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Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT

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ClinicalTrials.gov Identifier: NCT03336385
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Fibebiotics consortium (EU)
Information provided by (Responsible Party):
Robert Brummer, Örebro University, Sweden

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.

Condition or disease Intervention/treatment Phase
Prebiotics Aged Dietary Supplement: Naxus Dietary Supplement: Oatwell Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study participants were allocated through block randomization into three different intervention arms that ran in parallell throughout the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The randomization list was generated and provided by the Fibebiotics consortium (part of the EU framework 7 program) using unique study codes for participants.

All study product labels were coded by a third-party. All investigators and study participants remained blinded until final analysis

Primary Purpose: Supportive Care
Official Title: The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial
Actual Study Start Date : October 12, 2015
Actual Primary Completion Date : December 18, 2015
Actual Study Completion Date : December 18, 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
Maltodextrin 12 gram used as placebo
Dietary Supplement: Placebo
Maltodextrin as placebo

Active Comparator: Naxus
Naxus contains the wheat-derived prebiotic fibre Arabinoxylan
Dietary Supplement: Naxus
Non-digestible polysaccharides arabinoxylan (Naxus)
Other Name: Placebo

Active Comparator: Oatwell
Oatwell contains an oat-derived prebiotic beta-glucan fibre
Dietary Supplement: Oatwell
Non-digestible polysaccharides oat beta-glucan (Oatwell)




Primary Outcome Measures :
  1. Changes in delta indomethacin challenged permeability at end of intervention period [ Time Frame: 6 weeks ]
    In vivo multi-sugar permeability test


Secondary Outcome Measures :
  1. Changes in faecal microbiota composition at end of intervention period [ Time Frame: 6 weeks ]
    16S rRNA-based sequencing

  2. Changes in cytokine levels at end of intervention period [ Time Frame: 6 weeks ]
    Multiplex assay for IL-1β, IL-6, IL-8, IL-10, IL-2, IL-12p70, IFN-γ and TNF-α

  3. Changes in reactive oxygen species levels at end of intervention period [ Time Frame: 6 weeks ]
    FORT test for hydrogen peroxide

  4. Changes in gastrointestinal symptom questionnaire scores at end of intervention period [ Time Frame: 6 weeks ]
    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.

  5. Changes in hospital and anxiety depression scores at end of intervention period [ Time Frame: 6 weeks ]
    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. Changes in perceived stress scale scores at end of intervention period [ Time Frame: 6 weeks ]
    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.

  7. Changes in quality of life questionnaire scores at end of intervention period [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336385


Locations
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Sweden
Örebro University
Örebro, Sweden, 701 82
Sponsors and Collaborators
Örebro University, Sweden
Fibebiotics consortium (EU)
Investigators
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Principal Investigator: Robert J Brummer, MD, PhD Örebro University

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Responsible Party: Robert Brummer, Professor, MD, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT03336385     History of Changes
Other Study ID Numbers: FIT
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Brummer, Örebro University, Sweden:
Older adults
Prebiotics
Intestinal permeability
NSAIDS