An interventional study of Individual nutritional support in Malnutrition, Hepatitis B,Chronic and Acute-On-Chronic Liver Failure, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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Among 59 studies in Malnutrition with a site in China — 20 open to participants now, 21 under way, 1 of them phase 3. Malnutrition · China.
Among the 59 studies in Malnutrition with a site in China, this one is the 28th largest by planned enrollment of the 32 interventional ones that give a count, is one of 6 that started in 2023, is one of 19 with no phase, reaches primary completion later than 1 of the 20 other live ones, and was the 43rd registered.
1,278 studies on the registry are indexed under Malnutrition; 231 are open to participants now.
Browse Malnutrition studies →20 of the 59 studies in Malnutrition with a site in China are open now. Recruiting first, the newest first:
Huashan Hospital · Sites in China
Ages 61+
The Second Hospital of Nanjing Medical University · Sites in China
Ages 18–100
The Second Hospital of Nanjing Medical University · Sites in China
Ages 18+
Xiaoqin Luo · Sites in China
Ages 18+
Chengdu Qingshan Likang Pharmaceutical Co., Ltd · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 149 Malnutrition studies recruiting now, 84 (56%) set no upper age limit and 45 (30%) stop at 75 or younger; 40 take children under 18; 28 take healthy volunteers.
This study: 20 Years to 60 Years · all sexes · no healthy volunteers.
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59 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 6 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 118 across 844 interventional studies indexed under Malnutrition.
Median enrollment 120 across the 32 interventional studies, 500 across the 27 observational. Of the 24 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 59 have an industry lead sponsor. The 10 most frequent:
Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
Third Affiliated Hospital, Sun Yat-Sen University has 1 study filed under Malnutrition — fewer than ten, so there is no comparison to draw.
5 of the studies in Malnutrition with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05242055Capital Medical UniversityIntegrated Diagnosis and Treatment of CKD on Outcomes | 2026-12-31 |
| NCT06837194The Second Hospital of Nanjing Medical UniversityWashed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis | 2027-02-01 |
| NCT07136727The First Affiliated Hospital of Xinxiang Medical CollegeAI-Assisted Comprehensive Management for Cancer Patients With Comorbidities (GCOG-CG001) | 2027-05-01 |
| NCT07565415Nanfang Hospital, Southern Medical UniversityNanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy | 2027-09-01 |
| NCT07850375Institute of Hematology & Blood Diseases Hospital, ChinaNutritional Intervention for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation | 2027-10-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 59 studies in Malnutrition with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk
The aims of the randomized-controlled trial are to test the hypothesis that in medical inpatients with HBV related ACLF at risk for undernutrition defined by the nutritional risk score (NRS 2002), tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a effective strategy to prevent mortality, morbidity and functional decline.
Sixty patients with HBV related ACLF will be enrolled in this study. The participants are divided into trial Patients in the trail group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, others) based on a predefined nutritional strategy.In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated within first 3days ( oral supplements, parenteral nutrition) if targets are not met (at least 75% of targets).
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.
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 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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition.
Dietary Supplement: Individual nutritional support
30 patients will receive standard care food provided by the hospital kitchen according to their ability and desire, standard care food provided by the hospital kitchen.
Nutritional products and route（oral, parenteral）is possible to reach goals
Transplant free survival at 30 days
Time frame: 30 days
Transplant free survival at 90 days
Time frame: 90 days
L3-SMI as a marker of muscle mass
Third lumbar skeletal muscle index(L3-SMI) by CT scan
Time frame: 30 days, 90days
Grip as markers of muscle strength
Grip
Time frame: 30 days, 90days
Short Physical Performance Battery (SPPB) as markers of physical performance
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.
Time frame: 30 days, 90 days
Improvement in quality of life
Improvement in quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire on admission and during follow up measured by patient interview
Time frame: 30 days, 90days
length of hospital stay
days in the hospital within index hospitalisation and within the 90 days of follow up measured by patient interview and medical chart review
Time frame: days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review
Energy intake
Protein-calorie intake as assessed by serial 24-hour dietary recall
Time frame: 10 days
hepatic adverse outcomes
hepatic encephalopathy，esophageal variceal hemorrhage，etc
Time frame: 10days,30 days, 90 days
Combined safety endpoints in regard to side effects from nutritional therapy
Number of participants with side effects from nutritional support including (a) adverse gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain, abdominal distention) assessed by patient interview (yes/no) b) Complications due to center catheter for parenteral nutrition assessed by medical chart review (c) Refeeding syndrome assessed by chart review (d) Acute pancreatitis defined as 2 out of 3 criteria: abdominal pain, 3-fold increase in lipase or amylase, characteristic imaging findings assessed by chart review (e) Liver or gall bladder dysfunction assessed by chart review (f) Hyperglycemia (defined as glucose levels persistent levels \>10mmol/l in patients without diabetes or well controlled diabetes) assessed by medical chart review
Time frame: measured at day 10 and 30
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Apr 2024, 5 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 5 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Third Affiliated Hospital, Sun Yat-Sen University →