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

This study has been completed.
University of Reading
Information provided by (Responsible Party):
Clasado Identifier:
First received: February 23, 2011
Last updated: March 24, 2016
Last verified: March 2016
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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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

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 ]
  • Effect of B-GOS on the faecal microbiota composition of elderly persons [ Time Frame: 12 months ]
  • Effect of aging on body metabolites using NMR [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Effect of B-GOS on gut permeability [ Time Frame: 12 months ]
  • Weekly assessment of stools and gastrointestinal symptoms [ Time Frame: 8 months ]

Enrollment: 40
Study Start Date: May 2011
Study Completion Date: July 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: MDn
Dietary Supplement: Maltodextrin
5.5g daily for 10 weeks
Other Name: Dextrin
Active Comparator: B-GOS
Dietary Supplement: Bi2muno® GOS
5.5g/day for 10 weeks
Other Name: galactooligosaccharide


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01303484

United Kingdom
University of Reading
Reading, Berkshire, United Kingdom
Sponsors and Collaborators
University of Reading
Principal Investigator: Glenn Gibson, PhD University of Reading, United Kingdom
  More Information

Responsible Party: Clasado Identifier: NCT01303484     History of Changes
Other Study ID Numbers: Clasado2011
Study First Received: February 23, 2011
Last Updated: March 24, 2016 processed this record on June 23, 2017