Clinical trial NCT01303484: The Effect of Prebiotic B-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Immunosenescence
Lead sponsor: Clasado
Sponsor class: INDUSTRY
Collaborators: name: University of Reading
First posted: 2011-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers
timeFrame: 12 months
measure: Effect of B-GOS on the faecal microbiota composition of elderly persons
timeFrame: 12 months
measure: Effect of aging on body metabolites using NMR
timeFrame: 12 months
Secondary outcomes:
measure: Effect of B-GOS on gut permeability
timeFrame: 12 months
measure: Weekly assessment of stools and gastrointestinal symptoms
timeFrame: 8 months
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading, United Kingdom
name: Glenn Gibson, PhD
role: PRINCIPAL_INVESTIGATOR
References: