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
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
University of Reading🇬🇧Reading, Berkshire, United Kingdom