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

November 18, 2011
September 4, 2014
November 2011
December 2011   (final data collection date for primary outcome measure)
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.
Colonization after probiotic consumption. [ Time Frame: Changes from baseline in microbiota at 30 days and 45 days ] [ Designated as safety issue: Yes ]
The colonization of these probiotic strains in the intestinal microbiota will be measured in feces by means of Real Time Polimerase Chain Reaction.Tolerance will be measured by means of number of adverse events and safety by means of physical examination, blood biochemistry and haemogram and tolerance will be tested reporting of any symptoms of gastrointestinal discomfort and frecuency and aspects of stools daily recorded.
Complete list of historical versions of study NCT01479543 on ClinicalTrials.gov Archive Site
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).

Same as current
Not Provided
Not Provided
 
Effects of Probiotics in Immune System of Healthy Adults
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Conditions Influencing Health Status
  • 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
  • Other: Probiotic CNCM I-4035
    9x10E9 cfu (colony forming unit) per day during 28 days.
    Other Name: CNCM I-4035
  • Other: Probiotic CNCM I-4036
    9x10E9 cfu (colony forming unit) per day during 28 days.
    Other Name: 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
  • Other: Placebo
    Placebo capsule for 28 days.
    Other Name: Placebo, group E
  • Experimental: Group A
    Volunteers received Probiotic CNCM I-4034.
    Intervention: Other: Probiotic CNCM I-4034
  • Experimental: Group B
    Volunteers receive Probiotic CNCM I-4035.
    Intervention: Other: Probiotic CNCM I-4035
  • Experimental: Group C
    Volunteers are given Probiotic CNCM I-4036.
    Intervention: Other: Probiotic CNCM I-4036
  • Experimental: Group D
    Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
    Intervention: Other: Probiotics CNCM I-4035 and CNCM I-4036
  • Placebo Comparator: Group E
    Volunteers receive a Placebo.
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01479543
SETOPROB
Yes
Pedro Abellan, Hero Institute for Infant Nutrition
Hero Institute for Infant Nutrition
  • Universidad de Granada
  • University of Valencia
  • Universidad de Murcia
Study Chair: Pedro Abellán, PhD Hero Institute of Infant Nutrition
Hero Institute for Infant Nutrition
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP