Clinical trial NCT05584254: Effects of β-glucans on Gut Permeability and Microbiota in Elderly
Official title: Effects of β-glucan Based Dietary Fibres on Indomethacin-induced Hyperpermeability and Gut Microbiota Composition in Elderly: A Randomized Placebo-controlled Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Bowel Symptoms
Prebiotics
Keywords: elderly
prebiotics
permeability
clinical trial
Microbiota
Health
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Kerry Group
First posted: 2022-10-18
Enrollment: 43
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 study products (2 different forms of yeast-beta glucan and a placebo) taken in a cross-over design.
Primary purpose: TREATMENT

Brief summary: The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier function against drug-induced barrier disruption vs placebo for a cohort of elderly people with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over clinical trial.

Detailed description: Baseline samples for measurements of intestinal permeability (multisugar test), microbiota composition (faecal samples) and well-being (questionnaires) were collected during the first week for:

Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls) Elderly with gastrointestinal (GI) symptoms

Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial where they were blindly and randomly distributed one of the following: Soluble yeast-derived beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was taken for 3 weeks with a 1 week washout until all participants had taken all supplements. Towards the end of each supplement period, samples for measurement of intestinal permeability and microbiota were collected, in addition to questionnaires being filled out.

Eligibility criteria: Elderly with gastrointestinal symptoms

Inclusion Criteria:

* Informed consent signed by study participant
* Age \>55 years
* Scoring above 2 on the dimensions for diarrhoea and constipation on the Gastrointestinal symptoms rating scale (GSRS)
* Mentally and physically fit to complete questionnaires during the study period

Exclusion Criteria:

* Known or genic gastrointestinal diseasewith 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-inflammtory medication (including NSAIDs)

Healthy controls

Inclusion Criteria:

* Age ≥ 18 years
* Informed consent signed by the study participant
* Mentally and physically fit to complete questionnaires during the study period

Exclusion Criteria:

* Previous abdominal surgery
* A hypertonic condition demanding medical treatment
* Diagnosed psychiatric disease
* Lactose intolerance
* Usage of medical prescribed medications, expect oral contraceptives, during the 14 days preceding study start
* Premenstrual syndrome
* Pregnant or breast feeding
* 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.

Primary outcomes:
measure: Intestinal permeability at baseline (before indomethacin)
timeFrame: Day 1
measure: Intestinal permeability at baseline (after indomethacin)
timeFrame: Day 1
measure: Changes in Intestinal permeability 3 weeks after study supplementation 1 (before indomethacin).
timeFrame: 3 weeks
measure: Changes in intestinal permeability 3 weeks after study supplementation 1 (after indomethacin).
timeFrame: 3 weeks
measure: Changes in intestinal permeability 3 weeks after study supplementation 2 (before indomethacin)
timeFrame: 3 weeks
measure: Changes in intestinal permeability 3 weeks after study supplementation 2 (after indomethacin)
timeFrame: 3 weeks
measure: Changes in intestinal permeability 3 weeks after study supplementation 3 (before indomethacin)
timeFrame: 3 weeks
measure: Changes in intestinal permeability 3 weeks after study supplementation 3 (after indomethacin)
timeFrame: 3 weeks
Secondary outcomes:
measure: Microbiota diversity - at baseline
timeFrame: Day 1
measure: Bacterial species - at baseline
timeFrame: Day 1
measure: Changes in microbiota diversity 3 weeks after study supplementation 1
timeFrame: 3 weeks
measure: Changes in bacterial species 3 weeks after study supplementation 1
timeFrame: 3 weeks
measure: Changes in microbiota diversity 3 weeks after study supplementation 2
timeFrame: 3 weeks
measure: Changes in bacterial species 3 weeks after study supplementation 2
timeFrame: 3 weeks
measure: Changes in microbiota diversity 3 weeks after study supplementation 3
timeFrame: 3 weeks
measure: Changes in bacterial species 3 weeks after study supplementation 3
timeFrame: 3 weeks
measure: Changes in microbiota diversity - Washout (1 week after ending supplementation 1, i.e. 4 weeks after baseline)
timeFrame: 4 weeks
measure: Changes in bacterial species - Washout (1 week after ending study supplementation 1, i.e. 4 weeks after baseline)
timeFrame: 4 weeks
measure: Changes in microbiota diversity - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)
timeFrame: 4 weeks
measure: Changes in bacterial species - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)
timeFrame: 4 weeks
measure: Changes in microbiota diversity - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)
timeFrame: 4 weeks
measure: Changes in bacterial species - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)
timeFrame: 4 weeks
measure: Changes in gastrointestinal symptom questionnaire scores
timeFrame: up to 13 weeks
measure: Changes in hospital and anxiety depression scores
timeFrame: up to 13 weeks
measure: Changes in perceived stress scale scores
timeFrame: Up to 13 weeks
measure: Changes in quality of life questionnaire scores
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Campus USÖ, Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Robert J Brummer, PhD/MD
role: PRINCIPAL_INVESTIGATOR
References: