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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Immunosenescence

Intervention / Treatment
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* Dietary Supplement: Bi2muno® GOS
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: MDn<br>Maltodextrin | Dietary Supplement: Maltodextrin<br>* 5.5g daily for 10 weeks<br>* Other names: Dextrin;|
| Active Comparator: B-GOS<br>Prebiotic | Dietary Supplement: Bi2muno® GOS<br>* 5.5g/day for 10 weeks<br>* Other names: galactooligosaccharide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of B-GOS on gut permeability |  | 12 months | 
| Weekly assessment of stools and gastrointestinal symptoms |  | 8 months |