Effects of Probiotics in Immune System of Healthy Adults

Study Overview
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Brief Summary
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The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable conditions, with a positive contribution to health and wellbeing of healthy individuals. Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036), increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular intake has positive effects on the gastrointestinal and immune system.

Detailed Description
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The project will be based on a double-blind, randomized, and placebo-controlled clinical trial. It will be multi-Centre, with four groups plus a control group. The colonization performed by the strains and the modification of the intestinal microbiota will be evaluated by means of strain identification with RT-PCR equipped with specific primers, and bacterial population counting with in situ immunofluorescence techniques. The safety of strain intake will be evaluated with physical examination, blood parameters, and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora. Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the record of aspect and frequency of faeces. The effect on the systemic and adaptive immune system will be measured by means of lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC on faeces.

Official Title
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Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults

Conditions
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Conditions Influencing Health Status

Intervention / Treatment
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* Other: Probiotic CNCM I-4034
* Other: Probiotic CNCM I-4035
* Other: Probiotic CNCM I-4036
* Other: Probiotics CNCM I-4035 and CNCM I-4036
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult Age: 18-50 years Normal defecation Normal blood parameters Body Mass Index: 18-30 Exclusion Criteria: Pregnancy Lactation Antibiotic treatment Gastrointestinal disease Diarrhoea Constipation Diabetes Abnormal blood pressure Allergy Smoker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Volunteers received Probiotic CNCM I-4034. | Other: Probiotic CNCM I-4034<br>* Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.<br>* Other names: CNCM I-4034;|
| Experimental: Group B<br>Volunteers receive Probiotic CNCM I-4035. | Other: Probiotic CNCM I-4035<br>* 9x10E9 cfu (colony forming unit) per day during 28 days.<br>* Other names: CNCM I-4035;|
| Experimental: Group C<br>Volunteers are given Probiotic CNCM I-4036. | Other: Probiotic CNCM I-4036<br>* 9x10E9 cfu (colony forming unit) per day during 28 days.<br>* Other names: CNCM I-4036;|
| Experimental: Group D<br>Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036. | Other: Probiotics CNCM I-4035 and CNCM I-4036<br>* 9x10E9 cfu (colony forming unit) per day during 28 days.<br>* Other names: CNCM I-4035+CNCM I-4036;|
| Placebo Comparator: Group E<br>Volunteers receive a Placebo. | Other: Placebo<br>* Placebo capsule for 28 days.<br>* Other names: Placebo, group E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance After Probiotic Consumption. | Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention. | 4 weeks of the treatments. Daily recorded. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal and Immune Effects of Probiotics Consumption. | Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks). Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period). | At Time zero, after 4 weeks, and 2 later. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Immunity, Gastrointestinal symptoms