Microscopic ColitisNCT05058131
Modulation of Intestinal Barrier Function and Inflammation Via Butyrate-promoting Dietary Fibre
A study testing Dietary fibre in people with Microscopic Colitis, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Microscopic Colitis
- What is being tested?
- Dietary fibre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 3 Nov 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Diagnosis of microscopic colitis (collagenous or lymphocytic colitis)
- Active disease with no medication (e.g. budesonide) or stable budesonide treatment with or without symptoms
- Age between 18-75
Who cannot join
- Previous diagnosis of other organic gastrointestinal disease that interferes with the outcome parameters used in this study (e.g. ulcerative colitis)
- Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
- History of or present gastrointestinal malignancy or polyposis
- Diagnosis of gastrointestinal infection within the last 6 months
- Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease)
Show all 23Show fewer
- Autoimmune disease (e.g. rheumatoid arthritis)
- Chronic pain syndromes (e.g. fibromyalgia)
- Chronic fatigue syndrome
- Severe endometriosis
- Coeliac disease
- Diagnosis of lactose intolerance within the last 3 months
- Pregnancy or breast-feeding
- Regular intake of anti-inflammatory and/or other immunosuppressive medication than budesonide within the last 3 months
- Intake of proton pump inhibitors (e.g. omeprazol) within the last 4 weeks
- Use of anti-depressants within the last 3 months
- Regular intake of mast cell stabilizing drugs (e.g. sodium cromoglycate) within the last 3 months
- Antimicrobial treatment within the last 12 weeks before baseline sampling
- Antimicrobial prophylaxis (e.g. urinary tract infection)
- 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
- Inability to maintain current diet and lifestyle during the study period
- Alcohol or drug abuse
- Any clinically significant present or past disease/condition which the investigator considers to possibly interfere with the study outcome
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Örebro University
Örebro, Örebro County, 703 62
Richard A Forsgård, PhD, 0790614037 ext. +46, richard.forsgard@oru.se
Robert J Brummer, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Microscopic Colitis
- Being tested
- Dietary fibre, Placebo compound
- Medical subject headings
- Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fibreDietary supplement
Dietary fibre as a powder, 24 g per day for 6 weeks
Placebo compoundDietary supplement
Maltodextrin powder, 24 g per day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary fibre | Active comparator | Butyrate-promoting dietary fibre Receives: Dietary Supplement: Dietary fibre |
| Placebo compound | Placebo comparator | Placebo compound Receives: Dietary Supplement: Placebo compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic permeability in vivo
Difference in urinary sucralose/erythritol excretion ratio between the study arms
Measured: 6 weeks
Secondary outcomes (10)
Small intestinal permeability in vivo
Difference in urinary lactulose/rhamnose excretion ratio between the study arms
Measured: 6 weeks
Colonic permeability ex vivo in Ussing chambers
Difference in the translocation of FITC-labeled dextran and horseradish peroxidase between the study arms
Measured: 6 weeks
Concentrations of intestinal fatty-acid binding protein
Difference in plasma concentrations of intestinal fatty-acid binding protein between the study arms
Measured: 6 weeks
Concentrations of lipopolysaccharide-binding protein
Difference in plasma levels of lipopolysaccharide-binding protein between the study arms
Measured: 6 weeks
Concentratios of faecal calprotectin
Difference in faecal levels of calprotectin between the study arms
Measured: 6 weeks
Concentrations of faecal myeloperoxidase
Difference in faecal levels of myeloperoxidase between the study arms
Measured: 6 weeks
Concentrations of high-sensitive C-reactive protein
Difference in plasma levels of high-sensitive C-reactive protein between the study arms
Measured: 6 weeks
Concentrations of inflammatory cytokines
Difference in TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum between the study arms
Measured: 6 weeks
Composition of intestinal microbiota
Difference in the composition of intestinal microbiota between the study arms
Measured: 6 weeks
Functionality of intestinal microbiota
Difference in the levels of intestinal microbiota -derived metabolites in the serum and faeces between the study arms
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start3 Nov 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058131
- Sponsor's protocol ID
- MC-DF
- Status last verified
- Apr 2022
- First submitted
- 9 Sep 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fermentable Dietary Fibre Supplementation on Intestinal Permeability and Inflammation in Microscopic Colitis
- ClinicalTrials.gov ID
- NCT05058131
- Acronym / sponsor ID
- MC-DF
- Conditions
- Microscopic Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary fibre | Active comparator | Dietary Supplement: Dietary fibreButyrate-promoting dietary fibre |
| Placebo compound | Placebo comparator | Dietary Supplement: Placebo compoundPlacebo compound |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Diagnosis of microscopic colitis (collagenous or lymphocytic colitis)
- Active disease with no medication (e.g. budesonide) or stable budesonide treatment with or without symptoms
- Age between 18-75
Key exclusion criteria (23 listed)
- Previous diagnosis of other organic gastrointestinal disease that interferes with the outcome parameters used in this study (e.g. ulcerative colitis)
- Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
- History of or present gastrointestinal malignancy or polyposis
- Diagnosis of gastrointestinal infection within the last 6 months
- Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary fibreDietary fibre as a powder, 24 g per day for 6 weeks | Dietary supplement | Dietary fibre |
| Placebo compoundMaltodextrin powder, 24 g per day for 6 weeks | Dietary supplement | Placebo compound |
Primary outcome
Colonic permeability in vivo
Time frame: 6 weeks
Difference in urinary sucralose/erythritol excretion ratio between the study arms
10 secondary outcomes
Small intestinal permeability in vivo
Time frame: 6 weeks
Colonic permeability ex vivo in Ussing chambers
Time frame: 6 weeks
Concentrations of intestinal fatty-acid binding protein
Time frame: 6 weeks
Concentrations of lipopolysaccharide-binding protein
Time frame: 6 weeks
Concentratios of faecal calprotectin
Time frame: 6 weeks
Concentrations of faecal myeloperoxidase
Time frame: 6 weeks
Concentrations of high-sensitive C-reactive protein
Time frame: 6 weeks
Concentrations of inflammatory cytokines
Time frame: 6 weeks
Composition of intestinal microbiota
Time frame: 6 weeks
Functionality of intestinal microbiota
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Brummer, MD, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fibre in people with Microscopic Colitis, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard A Forsgård, PhD (0790614037 ext. +46, richard.forsgard@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic permeability in vivo (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.