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

Early Phase 1

Completed

• Conditions: Immunosenescence

• Registration Number: NCT01303484
• Lead Sponsor: Clasado

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Study Start: 2011-05
• Primary Completion: 2012-11
• Study Completion: 2014-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of B-GOS on gut permeability	12 months
Weekly assessment of stools and gastrointestinal symptoms	8 months

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom