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

Immunosenescence Clinical Trial

— PRIMES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303484
• Other study ID #: Clasado2011
• Status: Completed
• Phase: Phase 0
• First received: February 23, 2011
• Last updated: March 24, 2016
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: March 2016
• Source: Clasado
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunosenescence

Intervention

Dietary Supplement:
• Bi2muno® GOS
5.5g/day for 10 weeks
• Maltodextrin
5.5g daily for 10 weeks

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
Clasado	University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers		12 months	No
Primary	Effect of B-GOS on the faecal microbiota composition of elderly persons		12 months	No
Primary	Effect of aging on body metabolites using NMR		12 months	No
Secondary	Effect of B-GOS on gut permeability		12 months	No
Secondary	Weekly assessment of stools and gastrointestinal symptoms		8 months	No