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

This study has been completed.
Sponsor:
Collaborators:
Universidad de Granada
University of Valencia
Universidad de Murcia
Information provided by (Responsible Party):
Pedro Abellan, Hero Institute for Infant Nutrition
ClinicalTrials.gov Identifier:
NCT01479543
First received: November 18, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Conditions Influencing Health Status
Other: Probiotic CNCM I-4034
Other: Probiotic CNCM I-4035
Other: Probiotic CNCM I-4036
Other: Probiotics CNCM I-4035 and CNCM I-4036
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults

Further study details as provided by Hero Institute for Infant Nutrition:

Primary Outcome Measures:
  • Gastrointestinal Tolerance After Probiotic Consumption. [ Time Frame: 4 weeks of the treatments. Daily recorded. ] [ Designated as safety issue: No ]
    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:
  • Gastrointestinal and Immune Effects of Probiotics Consumption. [ Time Frame: At Time zero, after 4 weeks, and 2 later. ] [ Designated as safety issue: Yes ]

    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).



Enrollment: 103
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: CNCM I-4035+CNCM I-4036
Placebo Comparator: Group E
Volunteers receive a Placebo.
Other: Placebo
Placebo capsule for 28 days.
Other Name: Placebo, group E

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479543

Locations
Spain
Hero Institute of Infant Nutrition
Alcantarilla, Murcia, Spain, 30820
Murcia University
Espinardo, Murcia, Spain, 30071
Granada University
Granada, Spain, 18100
Valencia University
Valencia, Spain, 46010
Sponsors and Collaborators
Hero Institute for Infant Nutrition
Universidad de Granada
University of Valencia
Universidad de Murcia
Investigators
Study Chair: Pedro Abellán, PhD Hero Institute of Infant Nutrition
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pedro Abellan, Project Manager, Hero Institute for Infant Nutrition
ClinicalTrials.gov Identifier: NCT01479543     History of Changes
Other Study ID Numbers: SETOPROB
Study First Received: November 18, 2011
Results First Received: August 19, 2014
Last Updated: September 4, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Hero Institute for Infant Nutrition:
Probiotic
Immunity
Gastrointestinal symptoms

ClinicalTrials.gov processed this record on October 20, 2014