MedPath

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

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
NameTimeMethod
Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers12 months
Effect of B-GOS on the faecal microbiota composition of elderly persons12 months
Effect of aging on body metabolites using NMR12 months
Secondary Outcome Measures
NameTimeMethod
Effect of B-GOS on gut permeability12 months
Weekly assessment of stools and gastrointestinal symptoms8 months

Trial Locations

Locations (1)

University of Reading

🇬🇧

Reading, Berkshire, United Kingdom

University of Reading
🇬🇧Reading, Berkshire, United Kingdom

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.