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

Clasado

Status and phase

Completed

Early Phase 1

Conditions

Immunosenescence

Treatments

Dietary Supplement: Maltodextrin

Dietary Supplement: Bi2muno® GOS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01303484

Clasado2011

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

65 to 80 years old

Volunteers

Accepts Healthy Volunteers

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