The Effect of a Prebiotic, Probiotic and Synbiotic on the Gut Microbiota and Immune Response of Older Volunteers (GOS)
A Double-blind, Placebo-controlled, Randomized Crossover Study of a Prebiotic (Galacto-oligosaccharides, GOS), Probiotic (B.Lactis, BI07) and Synbiotic (GOS + BI07) on the Gut Microbiota and Immune Response of Older Volunteers
1 other identifier
interventional
40
1 country
1
Brief Summary
Healthy older volunteers will be recruited to a study where they will be given four different treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be collected and analysed for changes in faecal microbial populations and selected immune responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedApril 27, 2012
April 1, 2012
1.6 years
April 19, 2012
April 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Changes to the gut microbiota
The primary objective of this study is to determine the effect of GOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic (8g/day of GOS and 109 CFU/day of B. lactis BI07) on the human gut microbiota. Changes in the gut microbiota will be determined by measuring bacterial population levels in human faeces using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation. Faecal pH will be measured and the production of short chain fatty acids (SCFA) will be analysed and quantified using high performance liquid chromatography (HPLC).
Baseline and after 21d treatment
Secondary Outcomes (1)
Immune function
Baseline and after 21d treatment
Study Arms (4)
Synbiotic
EXPERIMENTAL8g/day gluco-oligosaccharide + 109 CFU/day B. lactis BI07
Placebo
EXPERIMENTAL8g/day maltodextrin
Prebiotic
EXPERIMENTAL8g/day galacto-oligosaccharides (GOS)
Probiotic
EXPERIMENTAL109 CFU/day B. lactis BI07
Interventions
8g/day galacto-oligosaccharide + 10\^9 CFU/day B.lactis
Eligibility Criteria
You may qualify if:
- a signed consent form,
- age \>60 years
- good general health
- not in the residential care.
You may not qualify if:
- evidence of physical or mental disease
- planned major surgery
- use of antibiotics within the previous six months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Readinglead
- Daniscocollaborator
Study Sites (1)
University of Reading
Reading, Berkshire, RG6 6AP, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert A Rastall
University of Reading
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post doctoral research fellow
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 26, 2012
Study Start
March 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
April 27, 2012
Record last verified: 2012-04