Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT

Aged Clinical Trial

Official title:

The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336385
• Other study ID #: FIT
• Status: Completed
• Phase: N/A
• Start date: October 12, 2015
• Est. completion date: December 18, 2015

Study information

• Verified date: August 2018
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 18, 2015
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aged
• Prebiotics

Intervention

Dietary Supplement:
• Naxus
Non-digestible polysaccharides arabinoxylan (Naxus)
• Oatwell
Non-digestible polysaccharides oat beta-glucan (Oatwell)
• Placebo
Maltodextrin as placebo

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Fibebiotics consortium (EU)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in delta indomethacin challenged permeability at end of intervention period	In vivo multi-sugar permeability test	6 weeks
Secondary	Changes in faecal microbiota composition at end of intervention period	16S rRNA-based sequencing	6 weeks
Secondary	Changes in cytokine levels at end of intervention period	Multiplex assay for IL-1ß, IL-6, IL-8, IL-10, IL-2, IL-12p70, IFN-? and TNF-a	6 weeks
Secondary	Changes in reactive oxygen species levels at end of intervention period	FORT test for hydrogen peroxide	6 weeks
Secondary	Changes in gastrointestinal symptom questionnaire scores at end of intervention period	The Gastrointestinal Symptoms Rating Scale (GSRS) evaluates gastrointestinal (GI) symptoms based on the 5 domains diarrhoea, constipation, reflux, indigestion and abdominal pain. The symptoms are assessed with 15 items, ranging in scores 1 to 7 depending on their severity. A score of 1 represents "no problems" and score 7 represents "severe problems". The severity of symptoms may be defined as no problems (1 point), mild (1-2 points), moderate (2-4 points), and severe (4-7 points). The scores for each domain was calculated as the mean score of each corresponding item while the mean total GSRS score reflects the general severity of GI symptoms.	6 weeks
Secondary	Changes in hospital and anxiety depression scores at end of intervention period	The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the psychological distress of study participants.This questionnaire consists of 14 items subdivided in two subscales for the assessment of anxiety or depression. The total score is used as a measure of general psychological distress. The minimum score is 0 and the maximum score is 21. A score > 8 on respective subscales indicates a significant level of anxiety or depression.	6 weeks
Secondary	Changes in perceived stress scale scores at end of intervention period	The perceived stress scale (PSS) consists of 10 items, including a number of direct questions about current levels of experienced stress. The respondent answers how often a certain emotion has been present during the past month. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Each item is rated on a 5-point scale ranging from never (0) to almost always (4). The questions in this scale ask about the responders feelings and thoughts during the last month. In each case the questionnaire requires the respondent to indicate by circling how often they felt or thought a certain way.	6 weeks
Secondary	Changes in quality of life questionnaire scores at end of intervention period	The EuroQol 5D-5L (EQ-5D-5L) tool consists of two parts; 5Q-5D, which includes 5 items related to wellbeing and function (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression) and the visual analogue scale, 5Q-5D-VAS, ranging from 0 to 100.	6 weeks