A Study of a Prebiotic, a Probiotic and a Synbiotic Upon the Gut Microbiota and Immune Response of Healthy Volunteers

Launched by UNIVERSITY OF READING · Feb 29, 2012

Keywords

ClinConnect Summary

The primary objective of this study is to determine the effect of XOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic combination of both (8g/day XOS and 109 CFU/day B. lactis BI07) on the human gut microbiota.

A double-blind, placebo-controlled, randomized crossover study will be conducted in 44 healthy volunteers. The placebo will be maltodextrin (a food grade ingredient, administered at 8g/day).

Changes in the gut microbiota will be determined by measuring bacterial population levels in human faeces using fluorescence in situ hybridisation (FISH...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • signed consent form
• • age 25-65 years
• • body mass index 20-30 inclusive
• • good general health as determined by medical questionnaires
• • additional inclusion criteria: as far as possible, target volunteer group will have mild constipation (bowel movement of less than 1/day, hard stool consistency)
• Exclusion Criteria:
• • • Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study
• • History of drug abuse, including alcohol
• • Severe allergy or a history of severe abnormal drug reaction
• • Participation in experimental drug trial within four weeks prior to study
• • Participation in prebiotics or laxative trial within the previous three months
• • Use of antibiotics within the previous six months
• • Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint
• • Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study
• • Use of prescribed medication
• • Regular use of aspirin or other anti-inflammatory drugs