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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-07-31

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

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Detailed Description

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Conditions

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Immunosenescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MDn

Maltodextrin

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

5.5g daily for 10 weeks

B-GOS

Prebiotic

Group Type ACTIVE_COMPARATOR

Bi2muno® GOS

Intervention Type DIETARY_SUPPLEMENT

5.5g/day for 10 weeks

Interventions

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Bi2muno® GOS

5.5g/day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

5.5g daily for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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galactooligosaccharide Dextrin

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes