Modulation of Intestinal Barrier Function and Inflammation Via Butyrate-promoting Dietary Fibre

April 20, 2022 updated by: Robert Brummer, Örebro University, Sweden

The Effects of Fermentable Dietary Fibre Supplementation on Intestinal Permeability and Inflammation in Microscopic Colitis

This study examines how a fermentable dietary fibre known to promote butyrate production impacts intestinal barrier function, intestinal microbiota, intestinal inflammation, and gastrointestinal symptoms in patients with microscopic colitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study examines the effects of a 6-week supplementation period with a dietary fibre product (type of wheat bran) on intestinal barrier function, intestinal inflammation, intestinal microbiota, and gastrointestinal symptoms in patients with MC. The study subjects will consume the study products (placebo-fibre, butyrate-promoting fibre) as a powder supplemented to their daily habitual diet. A maltodextrin-based product is used as placebo. After giving their informed consent, the study subjects fill out a background questionnaire to assess their eligibility for the study (Visit 1). Participants deemed suitable for the study will be randomised into two study arms (placebo-fibre, butyrate-promoting fibre) before undergoing a baseline visit (Visit 2) before the start of the intervention period. After the 6-week intervention period, the participants will come back for a final visit (Visit 3). In vivo intestinal permeability will be measured using the standard multi-sugar test at visits 2 and 3. Blood and faecal samples will also be collected during visits 2 and 3. In addition to the visits described above, a subset of patients (max. 20) will undergo a colonoscopy before and at the end of the intervention period at Örebro University Hospital where an experienced gastroenterologist collects 16 colonic biopsies. These colonic biopsies are mounted in an Ussing chamber system to specifically study colonic permeability. During visits 2 and 3, the participants also complete questionnaires to assess their gastrointestinal symptoms, quality of life, physical activity, and dietary habits. During the study period, the participants will also keep a daily diary recording the number of diarrheal and loose stools. The participants are asked to maintain their habitual diet and lifestyle as well as not to consume probiotic or prebiotic supplements.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
    • Örebro Län
      • Örebro, Örebro Län, Sweden, 703 62
        • Recruiting
        • Örebro university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Diagnosis of microscopic colitis (collagenous or lymphocytic colitis)
  3. Active disease with no medication (e.g. budesonide) or stable budesonide treatment with or without symptoms
  4. Age between 18-75

Exclusion Criteria:

  1. Previous diagnosis of other organic gastrointestinal disease that interferes with the outcome parameters used in this study (e.g. ulcerative colitis)
  2. Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
  3. History of or present gastrointestinal malignancy or polyposis
  4. Diagnosis of gastrointestinal infection within the last 6 months
  5. Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
  6. Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease)
  7. Autoimmune disease (e.g. rheumatoid arthritis)
  8. Chronic pain syndromes (e.g. fibromyalgia)
  9. Chronic fatigue syndrome
  10. Severe endometriosis
  11. Coeliac disease
  12. Diagnosis of lactose intolerance within the last 3 months
  13. Pregnancy or breast-feeding
  14. Regular intake of anti-inflammatory and/or other immunosuppressive medication than budesonide within the last 3 months
  15. Intake of proton pump inhibitors (e.g. omeprazol) within the last 4 weeks
  16. Use of anti-depressants within the last 3 months
  17. Regular intake of mast cell stabilizing drugs (e.g. sodium cromoglycate) within the last 3 months
  18. Antimicrobial treatment within the last 12 weeks before baseline sampling
  19. Antimicrobial prophylaxis (e.g. urinary tract infection)
  20. Regular intake of probiotics, nutritional supplements, or herb products that might affect intestinal function within the last 4 weeks if the investigator considers that those could affect study outcome
  21. Inability to maintain current diet and lifestyle during the study period
  22. Alcohol or drug abuse
  23. Any clinically significant present or past disease/condition which the investigator considers to possibly interfere with the study outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Dietary fibre
Butyrate-promoting dietary fibre
Dietary supplement: Dietary fibre
Dietary fibre as a powder, 24 g per day for 6 weeks
PLACEBO_COMPARATOR: Placebo compound
Dietary supplement: Placebo compound
Maltodextrin powder, 24 g per day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Colonic permeability in vivo
Time Frame: 6 weeks
Difference in urinary sucralose/erythritol excretion ratio between the study arms
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Small intestinal permeability in vivo
Time Frame: 6 weeks
Difference in urinary lactulose/rhamnose excretion ratio between the study arms
6 weeks
Colonic permeability ex vivo in Ussing chambers
Time Frame: 6 weeks
Difference in the translocation of FITC-labeled dextran and horseradish peroxidase between the study arms
6 weeks
Concentrations of intestinal fatty-acid binding protein
Time Frame: 6 weeks
Difference in plasma concentrations of intestinal fatty-acid binding protein between the study arms
6 weeks
Concentrations of lipopolysaccharide-binding protein
Time Frame: 6 weeks
Difference in plasma levels of lipopolysaccharide-binding protein between the study arms
6 weeks
Concentratios of faecal calprotectin
Time Frame: 6 weeks
Difference in faecal levels of calprotectin between the study arms
6 weeks
Concentrations of faecal myeloperoxidase
Time Frame: 6 weeks
Difference in faecal levels of myeloperoxidase between the study arms
6 weeks
Concentrations of high-sensitive C-reactive protein
Time Frame: 6 weeks
Difference in plasma levels of high-sensitive C-reactive protein between the study arms
6 weeks
Concentrations of inflammatory cytokines
Time Frame: 6 weeks
Difference in TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum between the study arms
6 weeks
Composition of intestinal microbiota
Time Frame: 6 weeks
Difference in the composition of intestinal microbiota between the study arms
6 weeks
Functionality of intestinal microbiota
Time Frame: 6 weeks
Difference in the levels of intestinal microbiota -derived metabolites in the serum and faeces between the study arms
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Faecal output measured by a daily diary
Time Frame: 6 weeks
Difference in the number of diarrhoeal stools per day between the study arms
6 weeks
Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale
Time Frame: 6 weeks
Difference in the frequency and severity of gastrointestinal symptoms between the study arms (15 questions with a scale of 1-7, minimum value 1, maximum 7, higher score correspond to a worse outcome)
6 weeks
Quality of life measured by EQ-5D-5L questionnaire
Time Frame: 6 weeks
Difference in the scores of the quality of life between the study arms (Visual Analog Scale 0-100, lower value corresponds to a worse outcome)
6 weeks
Anxiety and depression measured by Hospital Anxiety and Depression Scale
Time Frame: 6 weeks
Difference in the scores of anxiety and depression between the study arms (depression and anxiety scores separately, 7 questions each with a scale of 0-3, minimum score 0, maximum score 21 in both, higher value corresponds to a worse outcome)
6 weeks
General well-being measured by Short Health Scale
Time Frame: 6 weeks
Difference in the scores of general well-being between the study arms (4 questions with a scale of 1-7, higher scores correspond to a worse outcome)
6 weeks
Concentrations of systemic and faecal markers of oxidative stress
Time Frame: 6 weeks
Difference in blood and faecal markers of oxidative stress (e.g. glutathione) between the study arms
6 weeks
Concentrations of faecal chromogranins
Time Frame: 6 weeks
Difference in faecal levels of chromogranins between the study arms
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MC-DF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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