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

September 4, 2014 updated by: Pedro Abellan, Hero Institute for Infant Nutrition

Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18100
        • Granada University
      • Valencia, Spain, 46010
        • Valencia University
    • Murcia
      • Alcantarilla, Murcia, Spain, 30820
        • Hero Institute of Infant Nutrition
      • Espinardo, Murcia, Spain, 30071
        • Murcia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks of the treatments. Daily recorded.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At Time zero, after 4 weeks, and 2 later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hero Institute for Infant Nutrition

Collaborators

Universidad de Murcia
University of Valencia
Universidad de Granada

Investigators

  • Study Chair: Pedro Abellán, PhD, Hero Institute of Infant Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SETOPROB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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