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Completed

NCT Number: NCT01303484

The Effect of Prebiotic B-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

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Key information

Conditions

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Reading

Reading, Berkshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bi2muno® GOS

Dietary Supplement

5.5g/day for 10 weeks

Other names: galactooligosaccharide

Maltodextrin

Dietary Supplement

5.5g daily for 10 weeks

Other names: Dextrin

Primary outcomes

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

    Time frame: 12 months

  2. Effect of B-GOS on the faecal microbiota composition of elderly persons

    Time frame: 12 months

  3. Effect of aging on body metabolites using NMR

    Time frame: 12 months

Secondary outcomes

  1. Effect of B-GOS on gut permeability

    Time frame: 12 months

  2. Weekly assessment of stools and gastrointestinal symptoms

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Clasado

Industry

Collaborators

  • University of Reading

Registry information

Official study 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

Acronym: PRIMES

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Feb 24, 2011
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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