Effects of Probiotics in Immune System of Healthy Adults

Not Applicable

Completed

Interventions: Other: Probiotic CNCM I-4034
Other: Probiotic CNCM I-4036
Other: Probiotic CNCM I-4035
Other: Placebo
Other: Probiotics CNCM I-4035 and CNCM I-4036

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Group A	Probiotic CNCM I-4034	Volunteers received Probiotic CNCM I-4034.
Group C	Probiotic CNCM I-4036	Volunteers are given Probiotic CNCM I-4036.
Group B	Probiotic CNCM I-4035	Volunteers receive Probiotic CNCM I-4035.
Group E	Placebo	Volunteers receive a Placebo.
Group D	Probiotics CNCM I-4035 and CNCM I-4036	Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance After Probiotic Consumption.	4 weeks of the treatments. Daily recorded.	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.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal and Immune Effects of Probiotics Consumption.	At Time zero, after 4 weeks, and 2 later.	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).

Locations (4): Murcia University
🇪🇸
Espinardo, Murcia, Spain
Hero Institute of Infant Nutrition
🇪🇸
Alcantarilla, Murcia, Spain
Valencia University
🇪🇸
Valencia, Spain
Granada University
🇪🇸
Granada, Spain