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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Reading
Information provided by:
Clasado
ClinicalTrials.gov Identifier:
NCT01303484
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention Phase
Immunosenescence
Dietary Supplement: Bi2muno® GOS
Dietary Supplement: Maltodextrin
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Clasado:

Primary Outcome Measures:
  • Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effect of B-GOS on the faecal microbiota composition of elderly persons [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effect of aging on body metabolites using NMR [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of B-GOS on gut permeability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Weekly assessment of stools and gastrointestinal symptoms [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: MDn
Maltodextrin
Dietary Supplement: Maltodextrin
5.5g daily for 10 weeks
Other Name: Dextrin
Active Comparator: B-GOS
Prebiotic
Dietary Supplement: Bi2muno® GOS
5.5g/day for 10 weeks
Other Name: galactooligosaccharide

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303484

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Professor Glenn Gibson, University of Reading, United Kingdom
ClinicalTrials.gov Identifier: NCT01303484     History of Changes
Other Study ID Numbers: Clasado2011
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 15, 2014