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

March 24, 2016 updated by: Clasado

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 78 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers
Time Frame: 12 months
12 months
Effect of B-GOS on the faecal microbiota composition of elderly persons
Time Frame: 12 months
12 months
Effect of aging on body metabolites using NMR
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of B-GOS on gut permeability
Time Frame: 12 months
12 months
Weekly assessment of stools and gastrointestinal symptoms
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clasado

Collaborators

University of Reading

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Clasado2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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