Clinical trial NCT01479543: Effects of Probiotics in Immune System of Healthy Adults
Official title: Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions Influencing Health Status
Keywords: Probiotic
Immunity
Gastrointestinal symptoms
Lead sponsor: Hero Institute for Infant Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Granada
name: University of Valencia
name: Universidad de Murcia
First posted: 2011-11-24
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal Tolerance After Probiotic Consumption.
timeFrame: 4 weeks of the treatments. Daily recorded.
Secondary outcomes:
measure: Gastrointestinal and Immune Effects of Probiotics Consumption.
timeFrame: At Time zero, after 4 weeks, and 2 later.
Other outcomes:
Locations:
city: Alcantarilla
country: Spain
facility: Hero Institute of Infant Nutrition
state: Murcia
city: Espinardo
country: Spain
facility: Murcia University
state: Murcia
city: Granada
country: Spain
facility: Granada University
city: Valencia
country: Spain
facility: Valencia University
Study officials:
affiliation: Hero Institute of Infant Nutrition
name: Pedro Abellán, PhD
role: STUDY_CHAIR
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