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Completed

NCT Number: NCT01479543

Effects of Probiotics in Immune System of Healthy Adults

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.

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Key information

Conditions

Conditions Influencing Health Status

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Granada University, Granada, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic CNCM I-4034

Other

Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.

Other names: CNCM I-4034

Probiotic CNCM I-4035

Other

9x10E9 cfu (colony forming unit) per day during 28 days.

Other names: CNCM I-4035

Probiotic CNCM I-4036

Other

9x10E9 cfu (colony forming unit) per day during 28 days.

Other names: CNCM I-4036

Probiotics CNCM I-4035 and CNCM I-4036

Other

9x10E9 cfu (colony forming unit) per day during 28 days.

Other names: CNCM I-4035+CNCM I-4036

Placebo

Other

Placebo capsule for 28 days.

Other names: Placebo, group E

Primary outcomes

  1. Gastrointestinal Tolerance After Probiotic Consumption.

    Time frame: 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 outcomes

  1. Gastrointestinal and Immune Effects of Probiotics Consumption.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hero Institute for Infant Nutrition

Industry

Collaborators

  • Universidad de Granada
  • Universidad de Murcia
  • University of Valencia

Registry information

Official study title

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

Acronym: SETOPROB

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 24, 2011
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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