The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prebiotics
- Sponsor
- Örebro University, Sweden
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in delta indomethacin challenged permeability at end of intervention period
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier function against drug-induced barrier disruption in a general population of elderly people, in a randomized double blinded placebo-controlled clinical trial.
Detailed Description
The study consisted of a 9 week clinical trial to which the study participants orally ingested two different prebiotic compounds/one placebo for a total of 6 weeks. The primary outcome was intestinal permeability which was measured before/after indomethacin intake before starting with the prebiotic supplementation and repeated 6 weeks afterwards. Indomethacin is an NSAID known to artificially increase the intestinal permeability. The prebiotic fibers arabinoxylan and oat-derived beta-glucan have not been investigated for their effect on intestinal permeability in older adults. Intestinal permeability was investigated using the multi-sugar permeability test. Participants ingested a water solution containing 5 sugar probes that are taken up in different parts of the gut. These sugars are later recovered in the urine at two different time points, reflecting gastroduodenal, small intestinal and colonic permeability.
Investigators
Robert Brummer
Professor, MD
Örebro University, Sweden
Eligibility Criteria
Inclusion Criteria
- •Informed consent signed by study participant
- •Age ≥ 55 years
- •Mentally and physically fit to complete questionnaires during the study period
Exclusion Criteria
- •Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
- •Inflammatory bowel diseases (IBD)
- •Participation in other clinical trials in the past three months.
- •Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammatory medication (including NSAIDs)
Outcomes
Primary Outcomes
Changes in delta indomethacin challenged permeability at end of intervention period
Time Frame: 6 weeks
In vivo multi-sugar permeability test
Secondary Outcomes
- Changes in faecal microbiota composition at end of intervention period(6 weeks)
- Changes in cytokine levels at end of intervention period(6 weeks)
- Changes in hospital and anxiety depression scores at end of intervention period(6 weeks)
- Changes in reactive oxygen species levels at end of intervention period(6 weeks)
- Changes in gastrointestinal symptom questionnaire scores at end of intervention period(6 weeks)
- Changes in perceived stress scale scores at end of intervention period(6 weeks)
- Changes in quality of life questionnaire scores at end of intervention period(6 weeks)