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PRIMES: The Effect of Prebiotic B-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People

Sponsor
Clasado (Industry)
Overall Status
Completed
CT.gov ID
NCT01303484
Collaborator
University of Reading (Other)
40
Enrollment
1
Location
2
Arms
38
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Bi2muno® GOS
  • Dietary Supplement: Maltodextrin
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Placebo Controlled Cross- Over Study to Determine the Effect of prebioticB-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: MDn

Maltodextrin

Dietary Supplement: Maltodextrin
5.5g daily for 10 weeks
Other Names:
  • Dextrin

    		•
    Active Comparator: B-GOS

    Prebiotic

    Dietary Supplement: Bi2muno® GOS
    5.5g/day for 10 weeks
    Other Names:
  • galactooligosaccharide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers [12 months]

    2. Effect of B-GOS on the faecal microbiota composition of elderly persons [12 months]

    3. Effect of aging on body metabolites using NMR [12 months]

    Secondary Outcome Measures

    1. Effect of B-GOS on gut permeability [12 months]

    2. Weekly assessment of stools and gastrointestinal symptoms [8 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged between 65 and 80 years of age.

    • In good general health

    • The volunteer has given written informed consent to participate and is willing to participate in the entire study.

    Exclusion Criteria:

    • History or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.

    • Family history of colorectal cancer in under 50's

    • Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.

    • Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study (please note sensory evaluations are still permitted).

    • Undergone surgical resection of any part of the bowel.

    • History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).

    • Smoker

    • Lactose intolerant

    • Allergic to gluten

    • Currently prescribed immunosuppressive drugs. Participants will be required to withdraw should they begin taking any of the ineligible medication.

    • Intention to use regularly other medication which affects gastrointestinal motility and/or perception.

    • History of alcohol or drug misuse.

    • Suffer from any major conditions involving the following:

    Head, Ears, Eyes, Nose and Throat Dermatological/Connective tissue Coeliac disease Neurological Lymphatic Urogenital/Rectal Gastroenterological Abdominal Respiratory Cardiovascular Incontinence

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Reading Reading Berkshire United Kingdom

    Sponsors and Collaborators

    • Clasado
    • University of Reading

    Investigators

    • Principal Investigator: Glenn Gibson, PhD, University of Reading, United Kingdom

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clasado
    ClinicalTrials.gov Identifier:
    NCT01303484
    Other Study ID Numbers:
    • Clasado2011
    First Posted:
    Feb 24, 2011
    Last Update Posted:
    Mar 25, 2016
    Last Verified:
    Mar 1, 2016

    Study Results

    No Results Posted as of Mar 25, 2016