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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hero Institute for Infant Nutrition.
Recruitment status was  Recruiting
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: November 23, 2011
Last verified: November 2011
  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 Phase
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 capsule
Phase 1

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:
  • 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.


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).



Estimated Enrollment: 105
Study Start Date: November 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Volunteers are given strain CNCM I-4034.
Other: Probiotic CNCM I-4034
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 capsule
Placebo capsule for 28 days.
Other Name: Placebo

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

Contacts
Contact: Esther Matencio, Bachelor 34.968.89.89.00 ext 1166 esther.matencio@hero.es

Locations
Spain
Hero Institute of Infant Nutrition Recruiting
Alcantarilla, Murcia, Spain, 30820
Contact: Esther Matencio, Bachelor    34.968.89.89.00 ext 1166    esther.matencio@hero.es   
Contact: Fernando Romero, PhD    34.968.89.89.00 ext 1220    fernando.romero@hero.es   
Sub-Investigator: Fernando Romero, PhD         
Sub-Investigator: Francisco Sáez, PhD         
Sub-Investigator: María José Bernal, PhD         
Sub-Investigator: Esther Matencio, Bachelor         
Sub-Investigator: Rosario Martínez, Bachelor         
Sub-Investigator: Inmaculada Ortuño, Bachelor         
Sub-Investigator: Luis Manuel Sánchez, Bachelor         
Principal Investigator: Pedro Abellán, PhD         
Murcia University Recruiting
Espinardo, Murcia, Spain, 30071
Contact: Gaspar Ros, PhD    34.868.88.47.94    gros@um.es   
Contact: María Jesús Periago, PhD    34.868.88.47.94    mjperi@um.es   
Principal Investigator: Gaspar Ros, PhD         
Sub-Investigator: María Jesús Periago, PhD         
Sub-Investigator: Carlos Gómez, Bachelor         
Granada University Recruiting
Granada, Spain, 18100
Contact: Angel Gil, PhD    34.958.24.10.00    agil@ugr.es   
Contact: Carolina Gómez, PhD    34.958.24.10.00    gomezll@ugr.es   
Principal Investigator: Angel Gil, PhD         
Sub-Investigator: Julio Plaza, Bachelor         
Sub-Investigator: Carolina Gómez, PhD         
Sub-Investigator: Miriam Bermúdez, Bachelor         
Valencia University Recruiting
Valencia, Spain, 46010
Contact: Dolores Corella, PhD    34.963.86.44.17    dolores.corella@uv.es   
Contact: Olga Portolés, PhD    34.963.86.44.17    olga.portoles@uv.es   
Principal Investigator: Dolores Corella, PhD         
Sub-Investigator: Olga Portolés, PhD         
Sub-Investigator: Salvador Genovés, Bachelor         
Sub-Investigator: Empar Chernoll, PhD         
Sub-Investigator: Daniel Ramón, PhD         
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
Last Updated: November 23, 2011
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014