A Phase 3 interventional study of Bovine Colostrum and Placebo in Alcoholic Hepatitis, sponsored by Dayanand Medical College and Hospital. Active, not recruiting at 5 sites in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Dayanand Medical College and Hospital · Phase 3, Interventional, and Treatment
Severe alcohol-associated hepatitis (sAH)is associated with hepatocellular necrosis, inflammation, hyperactivated immune system, paradoxical immune exhaustion, leaky gut, and alteration in the gut microbiome. The leading cause of mortality is a bacterial infection with multi-organ failure.
Pentoxifylline was ineffective and Interleukin-1-based therapies - Anakinra and Canakinumab have not improved survival rates. The granulocyte colony-stimulating factor has shown mixed results. Indian studies improved 90-day survival, while Western studies on Pegfilgrastim have been negative. Corticosteroids decrease the mortality for only a month. In a recent study on Severe alcohol-associated hepatitis, Larsucosterol, a DNA methyltransferase inhibitor, was associated with non-significant improvement in 90-day mortality: 14.7 % (30 mg/day) and 16.67 % (90 mg/day) versus 24.27% on Methylprednisolone. Thus, a more durable treatment of severe alcohol-associated hepatitis is needed.
Bovine Colostrum contains many bioactive components such as immunoglobulin G, A, and M (70 - 80 % of total protein), Lactoferrin and Short-chain fatty acids. Bovine Colostrum has 30-100 times higher Lactoferrin concentration than milk. IgG and Lactoferrin synergistically neutralise lipopolysaccharide/ Endotoxin and act on mucosa-associated lymphoid tissue of the leaky gut, transforming it into healthy mucosa.
Fewer bacteria and Endotoxins - Pathogen-associated molecular patterns enter the portal circulation to interact with Toll-Like Receptor - 4 of the Liver Kupffer cells. Proinflammatory cytokines such as interleukins-1,6,8 and tumour necrosis factor-alpha, generation decreases, mitigating hepatocyte inflammation, necrosis, and cell death. We therefore conducted a multicenter, phase 3, double-blind, randomized, placebo-controlled trial to determine whether Bovine Colostrum, in addition to standard medical therapy, improves 90-day survival among patients with sAH. Secondary objectives were to assess its effects on liver disease severity, endotoxemia, systemic inflammatory markers, sepsis, and safety.
INTRODUCTION
Background and Rationale Severe alcoholic hepatitis (AH) imposes a significant global burden, markedly contributing to liver-related illness and death. The worldwide impact is driven by increasing alcohol consumption and the lack of effective treatments for severe cases. Chronic alcohol intake disrupts normal gut microbiome balance, leading to dysbiosis. This imbalance involves an increase in harmful bacteria and a decrease in beneficial ones, affecting overall gut health. Alcohol also damages the intestinal barrier, making it more permeable. This increased permeability allows bacteria and their harmful byproducts, such as lipopolysaccharides (LPS), to leak into the bloodstream. The leaked bacteria and LPS (pathogen-associated molecular patterns-PAMPs) reach the liver via the portal vein. In the liver, LPS activates toll-like receptor 4 (TLR4) on immune cells, triggering a pro-inflammatory response and hepatocyte necrosis. These PAMPs also contribute to systemic endotoxemia and septicaemia. Despite optimal medical therapy, often including prednisolone, severe alcohol-associated hepatitis has a 28-day mortality rate of 30-40%. The gut-liver axis has emerged as a promising target for treatment in sAH. Interventions such as antibiotics, nonabsorbable disaccharides, probiotics, and fecal microbiota transplantation have shown variable benefits in modulating intestinal permeability and microbial imbalance in cirrhosis. However, none are currently standard treatments for sAH. Furthermore, corticosteroids, while somewhat improving short-term survival, do not address the gut-driven inflammatory cascade and may increase the risk of infections. Bovine colostrum, the first milk produced after birth, is naturally rich in immunoglobulin G (IgG), lactoferrin, antimicrobial peptides, and short-chain fatty acids. Preclinical studies show that oral bovine colostrum can neutralize lipopolysaccharides, promote epithelial regeneration transforming the leaky gut into a healthy mucosal barrier, and modify the intestinal microbiota. These properties are highly relevant to reducing the pathogenic factors of sAH. Therefore, we conducted a multicenter, double-blind, placebo-controlled Phase 3 trial to determine whether adding oral IgG-enriched bovine colostrum to standard medical treatment could enhance survival and liver function in patients with sAH. Our hypothesis was that targeting the gut-liver axis with a safe, enterally delivered biologic would decrease systemic and hepatic inflammation, mitigate hepatocyte necrosis, lower infection rates, and improve clinical outcomes.
Natural History of Severe Alcohol-Associated Hepatitis in the West:
In the STOPAH study, 60% - 67% patients were males; baseline Maddrey's Discriminant Function was 61.9 + 25.7 and the Model For End-Stage Liver Disease was 20.7 + 5.5 in the Placebo arm. Out of the total 418 deaths, 168(40%) occurred before day 29, 28% occurred between days 28 and 90 , 32% occurred between day 91 and 1 year.
Background cirrhosis was in 86.2-93.7% patients with Severe Alcohol Associated Hepatitis treated with prednisone who had undergone liver biopsies
Natural History of Severe Alcohol-Associated Hepatitis in India:
In all Indian studies patients had a very severe disease as evidenced by the high Maddrey's Discriminant Function scores and Model For End-Stage Liver Disease scores. The majority of deaths occurred within the first month, with only a few deaths in the second and third months. The vast majority of these patients had underlying cirrhosis and were males. Corticosteroids could be offered in only 12%, due to contraindications in the rest of the patients - Acute Kidney Injury (37%) , infection (45%), Gastrointestinal bleed in (18%), patient's refusal in 17%.
Treatment Abstinence from alcohol This is the most important factor in predicting the outcome after surviving the acute Alcohol-Associated hepatitis (AH) episode.
Nutrition A careful evaluation of nutritional status and energy intake is done, with the aim to deliver 35-40 kcal/kg of body weight and a daily protein intake of 1.2-1.5 g/kg of body weight orally. Small frequent meals and a bedtime snack is advised. Supplementation of Thiamine, other B vitamins, Vitamin D, and trace elements, including Zinc, should be done.
Pharmacotherapy of Severe Alcohol-Associated Hepatitis Corticosteroids All recent Western studies have concluded that corticosteroid use decreases the 30-day, but not 90- or 180-day mortality rate in patients with Severe Alcohol-Associated Hepatitis. A more durable treatment of severe alcohol-associated hepatitis is needed. The Maddrey's Discriminant Function in the Western studies ranged from [Median (Inter Quartile Range)] 54.4 (39.2 - 76.1) to 69.7(53.7 - 89.4). The Model For End-Stage Liver Disease score ranged from [median (Inter Quartile Range)] 21.49 (19.95 - 22.89) to 25(22 - 27). The 90- day mortality rate was 30% in the STOPAH trial, 30% in the DASH trial and 26% in the AntiBiocor trial compared to 10% in the Gawrieh S, et al study due to younger patients in the last study. The pooled 90-day survival was 73.61% (95% CI: 68.18%-78.69%) in placebo-treated patients in above studies.
Combining four contemporary Indian studies on Severe Alcohol-Associated Hepatitis, the median Maddrey's Discriminant Function scores ranged from 70 (32 - 320) to 84 (56 - 185) and the median Model For End-Stage Liver Disease scores ranged from 26 (15 - 40) to 27.5 (19 - 41). The 90-day survival ranged from 22% - 56% on standard medical treatment.
The inference is that Severe Alcohol-Associated Hepatitis in Indian patients is more severe than in Western patients.
Hence, in light of the National Institute on Alcohol Abuse and Alcoholism recommendations, it is clear that Corticosteroids are not a therapeutic option for Indian patients as Maddrey's Discriminant Function and Model For End-Stage Liver Disease scores are very high.
Although our pilot study conducted in 2015 had shown that treatment with a combination of Bovine Colostrum and Corticosteroids had improved the Maddrey's Discriminant Function level and survival rate at 3 months significantly, we would only use Bovine Colostrum as a therapeutic option versus standard medical treatment, rather than use corticosteroids as a active comparator arm which has no impact on the 90-day mortality and is often contraindicated in sAH patients with sepsis, acute kidney failure, upper gastrointestinal bleeding
Larsucosterol Larsucosterol, an endogenous oxysterol, is an epigenetic inhibitor of DNA methyltransferases, mitigating apoptosis. In a recent study (Model of End-Stage Liver Disease score-24, Maddrey's discriminant function scores 57.2 - 63), Larsucosterol was associated with non-significant improvement in 90-day mortality: 15.2 % (30 mg/day) and 16.8 % (90 mg/day) versus 24.5% on Methylprednisolone. However, the severity of hepatitis was milder compared to Indian our studies.
Failed Treatments Pentoxifylline was ineffective, and Interleukin-1-based therapies - Anakinra and Canakinumab have not improved survival rates. The granulocyte colony-stimulating factor has shown mixed results. Indian studies improved 90-day survival, while Western studies on Pegfilgrastim have been negative.
Bovine colostrum Composition and Rationale for its Treatment Potential in Severe Alcohol-Associated Hepatitis The Bovine Colostrum has the following components: fat, protein, peptides, lactose ,immunoglobins, lactoferrin, lysozyme, lactoperoxidase, insulin growth factor-I .
Colostrum contains elevated levels of IgG, IgA, and IgM, which make up 70-80% of the total protein in colostrum. Short-Chain Fatty Acids in Colostrum improve the integrity of the intestinal inner cell membrane. The lactoferrin concentration in colostrum is 30 - 100 fold higher than that in milk.
Lactoferrin binds to lipid A of Lipopolysaccharide (LPS) to neutralize it. IgG and lactoferrin synergistically neutralize LPS. IgG and lactoferrin interact with mucosa-associated lymphoid tissue of leaky mucosal barrier to convert into healthy mucosal barrier. It increases the growth and proliferation of enterocytes.
Additionally, lactoferrin has an impact on the levels of cytokines and chemokines that are produced by Gut-Associated Lymphoid Tissue and creates an environment for the growth of beneficial bacteria in the gut. Fewer bacteria and LPS /Endotoxin, - pathogen-associated molecular particles enter the Portal vein resulting in decreased trafficking and interaction of bacteria and LPS with Toll-like receptors-4 of the macrophages and Kupffer Cells in the liver. The production of pro-inflammatory cytokines such as interleukin-1 beta,6,8,10, (IL-1 beta,6,8,10), Reactive Oxygen Species (ROS) and Tumour necrosis factor-alpha (TNF-alpha) are decreased and hepatocellular necrosis is mitigated.
Thermal processing of colostrum In studies conducted by Donahue and Godden et al., heating colostrum at 60 °C for 60 min decreased total plate counts, coliform counts and other pathogens, but did not affect native IgG concentration.
Derivation of Dose of Bovine Colostrum Oral bovine colostrum preparation (Lactobin®) 56g/day was given prophylactically to 20 patients for 3 days preoperatively who underwent abdominal surgeries, and (Placebo) standard milk 56 g/day was given for 3 days to 20 similar patients.
The course of the plasma endotoxin / LPS levels and the endotoxin neutralization capacity were measured daily up to the 10th postoperative day. The results showed that the LPS levels in the Lactobin group, were significantly lower than those in the control group (p \< 0.05). The difference between the two groups was apparent on the day of the operation and the day after. There was a significantly greater increase in endotoxin-neutralizing capacity in the patients treated with lactobin than in the control group (p\<0.006). Thus, Bovine Colostrum has been successfully used to decrease the level of Endotoxemia / Lipopolysaccharides.
In the second placebo-controlled randomized study, 60 patients who underwent coronary bypass operations were administered either 42 g of a Bovine colostrum milk preparation per day or placebo for 2 days preoperatively. There was no reduction in Endotoxin levels and no increase in endotoxin-neutralizing capacity levels in patients receiving the lower dose of Colostrum. Thus, the correct dose of Bovine Colostrum appears to be 60 grams/day.
The Bovine Colostrum used in our study differed in composition and processing from that used in the Lactobin® preparation. While Lactobin® contained 80% protein and 52 mg of IgG per gram of protein (4.16 grams of IgG per 100 grams of BC), the BC used in the current study contained 52.75% protein and 342.5 mg of IgG per gram of protein - 18.09 grams of IgG per 100 grams of BC). The higher IgG concentration in Bovine Colostrum is attributable to freeze-drying. Lactobin® was prepared by spray drying. The shelf life of the freeze-dried Bovine Colostrum powder was 24 months at room temperature (20 - 25 °C). The Bovine Colostrum powder was packaged in aluminum-laminated packaging.
Trial design This is a multicentre, parallel, double-blind, randomised (1:1), placebo-controlled trial.
Methods: Participants Study setting The study will recruit patients admitted with "probable" Severe Alcohol-Associated Hepatitis at five academic centers and Hospitals in India. The accuracy of a clinical diagnosis of "probable Alcohol-Associated Hepatitis using the Crabbe et al criteria is 96%. Thus patients can be started on initiating treatment promptly on presentation rather than to rely upon histology which may delay assessment .Hence , no patients underwent liver biopsy.
Relevant concomitant care given during the trial Standard of care treatment will be given in both arms are as follows- Oral / Enteral nutrition (if oral intake is insufficient: Protein 1.2 -1.5 gm/kg/day, energy (kcal) 35-40/day, small frequent feeds with a bedtime snack of 50 g of complex carbohydrates with 13.5 g of proteins and B complex vitamins daily. Antibiotics for sepsis; Salt restriction and Diuretics for Ascites; Lactulose / Rifaximin / L Ornithine L Aspartate for Hepatic Encephalopathy; Terlipressin and Albumin for Type 1 Hepato Renal Syndrome; Carvedilol for prophylaxis against variceal hemorrhage; Terlipressin with Endoscopic Variceal Ligation for variceal bleed, if indicated.
Criteria for discontinuing or modifying allocated interventions for a given trial participant Occurrence of adverse effects of Bovine colostrum (Experimental arm) and pasteurised milk powder (placebo comparator): Allergy, Lactose Intolerance Strategies to improve adherence to intervention protocols All patients will be initially admitted to the hospital ICU / wards. After discharge from the hospital, the patients will be contacted telephonically and reminded to shall return for outpatient visits after 7 days, 14 days, 21 days, 28 days, and then bimonthly for two months. At the outpatient visit, history, physical examination, and laboratory tests will be done. The patients will return the empty sachets (which will be counted), and a new batch of sachets will be given until the next outpatient visit
Investigations
Each patient shall have an:
i. Assessment of effect of Intervention on Intestinal Barrier function: Serum Endotoxin levels as well as the TNF -alpha levels (an important downstream pro-inflammatory mediator).
Sample size determination In an Indian study of patients suffering from Severe Alcohol-Associated Hepatitis, published in 2014 by Singh et al , the Maddrey Discriminant Function score was 77.4 (range: 37- 235), the Model for End-Stage Liver Disease score was 27.5 (range:19- 41), and the survival rate was 22% at 90 days in the standard medical treatment arm and was 78.3% in Granulocyte Colony Stimiulating Arm.
Hence, we calculated the sample size based on the above study We considered a 20% increase in survival rate (80% power at 5% alpha), to be clinically meaningful and sufficient to change practice. To detect a 20% increase in survival (from 22% to 42%) in 3 months [the sample size was based on survival at a fixed time point (22% vs 42% at 3 months)], we required 79 patients in each group. Assuming, 10% dropouts. the total sample size required for the study is 174.
Randomisation Consecutive patients diagnosed with Severe Alcohol-Associated hepatitis will be then registered by the site medical team onto the trial site via Trans European Network for clinical trials services, a web-based registration and randomisation system, and randomised into two groups (groups A and B) to receive active drug or placebo 1:1.
Blinding Treatment allocation will be blinded to patients, investigators, data collectors, and statisticians by providing each patient with a unique number from the Trans European Network for clinical trials services registration system
Statistical methods Statistical methods for primary and secondary outcomes
Subject population (S) for analysis:
For primary survival (efficacy) analysis, we will use intention-to-treat analysis, in such a way that all study subjects who are randomized, regardless of adherence to study medication, will be used in the analysis in the treatment arms to which they are originally assigned to at randomization ("as randomized"). Significance will be assessed using a two-sided alpha level of 0.05.
Baseline Patients' Characteristics The baseline patients' characteristics will be compared between the two treatment groups to demonstrate the actual study group balance and to ensure whether a proper randomization is established or not. We will measure central tendency and variability with means and standard deviations or medians and interquartile range for continuous characteristics and frequencies with percentages for categorical characteristics.
Primary Outcome Unadjusted Log-Rank Test Of The Kaplan-Meier Survival Estimates This test for the two treatment arms has a at a two-sided alpha level of 0.05 with survival censored at 3 months.
Hazard Ratios Further, a Cox proportional hazards regression model (with survival censored at 3 months) will be used to estimate the hazard ratio with a 95% confidence interval associated with the treatment arm (A) compared to the Placebo (B). The Cox proportional Hazards will be estimated both unadjusted and Adjusted (For Centre, baseline MELD score, baseline alcohol intake, alcohol relapse of alcohol, acute kidney injury, severity of ascites ) .
Scaled Schoenfeld Residuals plots The pattern against the time in these plots will be observed. If a nonrandom pattern is observed, this will be considered a violation of the Proportional Hazards assumption.
Restricted Mean Survival Time To address the violation of the proportional hazards assumption, the restricted mean survival time for both treatment arms over 90 days for the Actual Observed outcome and the Worst Case Scenario will be calculated.
Secondary Outcomes A similar unadjusted log-rank test of the Kaplan-Meier survival estimates and Cox proportional hazards regression model analysis will be planned for secondary outcome survival at 1 month. In the graphical Scaled Schoenfeld tests, the pattern against the time in these plots will be observed. If a non-random pattern is observed ,we will then calculate the restricted mean survival time for both treatment arms over 30 days for the Actual Observed outcome and the Worst Case Scenario.
Other secondary outcomes measures such as Change in Maddrey Discriminant Factor levels/ Model For End-Stage Liver Disease score, Endotoxin levels, and Cytokines levels between baseline and 4 weeks assessment will be assessed for normal distribution by graphical (Quantile-Quantile Plot) interpretation and numerical method (Kolmogorov-Smirnov test). A paired t-test will be used for all those outcomes which will follow approximately normal distribution and a Mann-Whitney U test will be used for skewed parameters.
Longitudinal changes in MELD and mDF scores were evaluated using joint models linking repeated measurements to survival. Recurrent sepsis episodes were analyzed using generalized estimating equations (baseline sepsis) and partial proportional odds models (sepsis occurring during the treatment period).
No formal interim analysis is planned for this trial. Monitoring for Adverse Events A treatment-emergent Adverse Event will be defined as an Adverse Event that begins or that worsens in severity after at least one dose of the study drug has been administered. Any adverse event occurring during the study will be documented in the subject's Case Report Form specifying the time of onset, the duration, the severity, and the relationship to the test medication
Grades of Severity of the Adverse Event as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0:
113 studies on the registry are indexed under Hepatitis, Alcoholic; 24 are open to participants now.
This study's enrollment of 174 is above the median of 60 across 80 interventional studies indexed under Hepatitis, Alcoholic.
Browse Hepatitis, Alcoholic studies →Dayanand Medical College and Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Protein 1.2 -1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a lyophilised freeze dried powder (20 gm thrice a day) for 4 weeks. \+ Antibiotics + Diuretics +Terlipressin along with IV Albumin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed +drugs for HE if indicated
Drug: Bovine Colostrum
Placebo (Pasteurized Milk Powder) 20 gms thrice a day for 4 weeks; isocaloric, isonitrogenous to the Bovine Colostrum, three times daily for 4 weeks, in addition to standard medical therapy and nutritional support. The placebo was formulated to match BC in appearance, consistency, and taste Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. \+ Antibiotics + Diuretics + drugs for HE + Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed + if indicated.
Drug: Placebo
Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a freeze dried powder (20 gm thrice a day) for 4 weeks. \+ Antibiotics + Diuretics +Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed +drugs for HE if indicated
Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Placebo (Pasteurised Milk Powder) 20 gms thrice a day for 4 weeks \+ Antibiotics + Diuretics + drugs for HE + Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed + if indicated.
Survival
Survival at 3 month
Time frame: 3 month
Change in mDF and MELD levels
Change in mDF and MELD levels will be measured at baseline and after 30 days of treatment
Time frame: one month
Change in Endotoxin levels
Change in Endotoxin levels will be measured at baseline and after 4 weeks of treatment
Time frame: one month
Change in Cytokines levels
Change in Cytokines levels will be measured at baseline and after 30 days of treatment
Time frame: one month
Number of episodes of sepsis
Number of episodes of sepsis (bacteremia, Pneumonia, SBP, Cellulitis, UTI) \[Criteria for defining infections in cirrhosis are appropriate for Severe Alcohol-Associated Hepatitis\] {32. Bajaj JS, O'Leary JG, Reddy KR, Wong F, Olson JC, Subramanian RM, Brown G, Noble NA, Thacker LR, Kamath PS; NACSELD. Second infections independently increase mortality in hospitalized patients with cirrhosis: the North American consortium for the study of end-stage liver disease (NACSELD) experience. Hepatology. 2012 Dec;56(6):2328-35. doi: 10.1002/hep.25947. PMID: 22806618; PMCID: PMC3492528.}
Time frame: 1 month
Survival
Survival at 1 month
Time frame: 1 month
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Aug 2024, 80 months.
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Studies of the drug tested here: BOS taurus colostrum
Dayanand Medical College and Hospital