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
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: 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 September 18, 2014