Effects of Probiotics in Immune System of Healthy Adults (SETOPROB)

Hero Institute for Infant Nutrition

Status: Completed

Conditions: Conditions Influencing Health Status

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01479543

SETOPROB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

103 participants in 5 patient groups, including a placebo group

Group A

Experimental group

Description:

Volunteers received Probiotic CNCM I-4034.

Treatment:

Other: Probiotic CNCM I-4034

Group B

Experimental group

Description:

Volunteers receive Probiotic CNCM I-4035.

Treatment:

Other: Probiotic CNCM I-4035

Group C

Experimental group

Description:

Volunteers are given Probiotic CNCM I-4036.

Treatment:

Other: Probiotic CNCM I-4036

Group D

Experimental group

Description:

Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.

Treatment:

Other: Probiotics CNCM I-4035 and CNCM I-4036

Group E

Placebo Comparator group

Description:

Volunteers receive a Placebo.

Treatment:

Other: Placebo