Clinical trial NCT03336385: Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT
Official title: The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prebiotics
Aged
Keywords: Older adults
Prebiotics
Intestinal permeability
NSAIDS
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Fibebiotics consortium (EU)
First posted: 2017-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants were allocated through block randomization into three different intervention arms that ran in parallell throughout the study
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Changes in delta indomethacin challenged permeability at end of intervention period
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in faecal microbiota composition at end of intervention period
timeFrame: 6 weeks
measure: Changes in cytokine levels at end of intervention period
timeFrame: 6 weeks
measure: Changes in reactive oxygen species levels at end of intervention period
timeFrame: 6 weeks
measure: Changes in gastrointestinal symptom questionnaire scores at end of intervention period
timeFrame: 6 weeks
measure: Changes in hospital and anxiety depression scores at end of intervention period
timeFrame: 6 weeks
measure: Changes in perceived stress scale scores at end of intervention period
timeFrame: 6 weeks
measure: Changes in quality of life questionnaire scores at end of intervention period
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Robert J Brummer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: