An interventional study of Tropical juice with probiotics (B.coagulans) and a Tropical juice with no probiotics in Lactose Intolerance, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Not applicable, Interventional, and Treatment
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.
Based on the foregoing, the group research has design a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.
Probiotics are defined by Food and Agriculture Organization of the United Nations and World Health Organization (FAO/WHO) as "living microorganisms that, properly administrated, confers a benefit on individual's health". Probiotics definition it's closely related to functional food concept, which encompasses either products or ingredients that are able to exert a positive impact on individual's health beyond their nutritional value. In fact, most of consumers in developed countries, strongly associate probiotics as functional foods. Lactic acid bacteria are the main microorganisms used as a probiotic, being Lactobacillus, Bifidobacterium, Propionibacterium and Streptococcus genus the most applied. Additionally, some Saccharomyces yeast may be used as probiotics.
However, a microorganism should present particular characteristic in human gastrointestinal's tract to be considered as a probiotic, following the Joint FAO/WHO Group directions: resistance to gastric and pancreatic secretions; adherence to intestinal epithelium and mucosa; antimicrobial activity against pathogenic bacteria; capability of reducing pathogen adhesion on intestinal epithelium; and present certain enzyme activity. The former bacteria genus fulfill most of the previous characteristics. However, these microorganism survival on gut is quite low (1-15%). For this reason, recent Works are searching for microorganism genus able to survive in a larger extend in gut.
Non-pathogenic bacteria of Bacillus genus have spore forming ability in the gastrointestinal tract. Specifically, Bacillus coagulans strain has been subject of new studies. B. coagulans has an optimal growth temperature of 35-50ºC, with pH conditions nearby 6. This microorganism consumes glucose, sucrose, maltose and mannitol while growing to produce lactic acid. In addition, B.coagulans is able to produce some enzymes (depending on the strain) such as alpha and beta-galactosidase, alpha-amylase, lipase and protease. However, the capability of growing in gut depends on time from its consumption (mostly oral) and the spore generation rate. The optimal dose is about 9,52x10e11 UFC, if an standard adult of 70 Kg is assumed. In addition, several studies have proved the B.coagulans ability of forming spores in presence of energy sources such as fructose and lactose.
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.
Based on the foregoing, the group research has designed a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 40 is close to the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Volunteers will consume once a day for 1 month a tropical juice (orange, mango, pineapple and turmeric) and a lactase tablet
Other: a Tropical juice with no probiotics · Other: lactase tablet
Volunteers will consume once a day for 1 month the probiotic added to a liquid matrix (tropical juice) and and a placebo tablet (cornstarch)
Dietary Supplement: Tropical juice with probiotics (B.coagulans) · Other: placebo tablet (cornstarch)
Once a day during all the intervention phase, volunteers with lactose intolerance should allow the spore-forming ability of B. coagulans in order to digest lactase from dairy products through regular consumption of Tropical juice with probiotics (B.coagulans)
Once a day during all the intervention phase, volunteers with lactose intolerance should consume a Tropical juice with no probiotics
lactase tablet
placebo tablet (cornstarch)
Gastrointestinal symptoms
The questionnaire developed by Casellas et al. 2009 on the specific symptoms of lactose intolerance. The patient will indicate on a scale of 1 to 10 the intensity of the following gastrointestinal symptoms: abdominal pain, bloating, flatulence, diarrhea and cramps. The scale indicates the total absence of symptoms (0) or their severe presence (10).
Time frame: 3 months
Sensory perception
It is evaluated using a visual analog scale (VAS) on different sensory aspects of the product: the desire to take it, taste, smell, consistency and effectiveness of its consumption. The scale analyzes values between 0% (most negative values) or 100% (extremely positive values).
Time frame: 3 months
Physical activity
Use of International Physical Activity Questionnaire (IPAQ) to determine changes on physical activity during the clinical trial
Time frame: 3 months
Waist circumference
Data referring to the waist circumference of the Spanish population allow to estimate cardiovascular risk parameters from 95 cm in men and 82 cm in women, and very high risk from 102 cm in men and 90 cm in women. The measurement is taken at the narrowest point between the last rib and the iliac crest, with the tape against the skin but not compressed. The person should be kept in an upright position, distributing the weight equally on both legs and their arms relaxed at the sides of the body.
Time frame: 3 months
Body weight
Body weight is measured using a digital scale for clinical use (capacity 0 - 150 kg), with the person positioned with their back to the viewer, without shoes, with a minimum of warm clothing (pants and t-shirt), heels together, looking towards straight forehead and body posture.
Time frame: 3 months
Digestive Symptoms Questionnaire (GSRS)
Assessment of digestive symptoms throughout the study. The questionnaire includes 15 items grouped into 5 blocks based on different gastrointestinal symptoms. The 5 groups of symptoms are: reflux, abdominal pain, indigestion, diarrhea and constipation. Subject is asked about pain or discomfort in the upper abdomen or pit of the stomach, heartburn, acid reflux, hunger, nausea, "gut rumbling," bloating, belching, farting, constipation , diarrhoea, loose or hard stools, an urgent need to have a bowel movement and a feeling of not having finished having a bowel movement. It is scored based on a 7-point Likert-type scale, where 1 represents the most positive option and 7 the most negative. The equivalence in this questionnaire would be: 1 asymptomatic; 2 slight discomfort; 3 mild symptoms; 4 moderate symptoms; 5 moderately severe symptoms; 6 severe symptoms; 7 very serious symptoms
Time frame: 3 months
Changes in stool quality
Bristol scale to find out changes in stool form and stool frequency. The Bristol scale has 7 groups: types 1 and 2 are indicative of constipation, types 3 and 4 are desirable stools, especially 4, since they are the easiest to defecate, finally types 5, 6 and 7 are indicative diarrhea or cholera
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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