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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary fibre | Active Comparator | Butyrate-promoting dietary fibre |
|
| Placebo compound | Placebo Comparator | Placebo compound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary fibre | Dietary Supplement | Dietary fibre as a powder, 24 g per day for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Colonic permeability in vivo | Difference in urinary sucralose/erythritol excretion ratio between the study arms | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Small intestinal permeability in vivo | Difference in urinary lactulose/rhamnose excretion ratio between the study arms | 6 weeks |
| Colonic permeability ex vivo in Ussing chambers | Difference in the translocation of FITC-labeled dextran and horseradish peroxidase between the study arms |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal output measured by a daily diary | Difference in the number of diarrhoeal stools per day between the study arms | 6 weeks |
| Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard A Forsgård, PhD | Contact | 0790614037 | +46 | richard.forsgard@oru.se |
| Name | Affiliation | Role |
|---|---|---|
| Robert J Brummer, MD, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Recruiting | Örebro | Örebro County | 703 62 | Sweden |
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| ID | Term |
|---|---|
| D046728 | Colitis, Microscopic |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Placebo compound |
| Dietary Supplement |
Maltodextrin powder, 24 g per day for 6 weeks |
|
| 6 weeks |
| Concentrations of intestinal fatty-acid binding protein | Difference in plasma concentrations of intestinal fatty-acid binding protein between the study arms | 6 weeks |
| Concentrations of lipopolysaccharide-binding protein | Difference in plasma levels of lipopolysaccharide-binding protein between the study arms | 6 weeks |
| Concentratios of faecal calprotectin | Difference in faecal levels of calprotectin between the study arms | 6 weeks |
| Concentrations of faecal myeloperoxidase | Difference in faecal levels of myeloperoxidase between the study arms | 6 weeks |
| Concentrations of high-sensitive C-reactive protein | Difference in plasma levels of high-sensitive C-reactive protein between the study arms | 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 | 6 weeks |
| Composition of intestinal microbiota | Difference in the composition of intestinal microbiota between the study arms | 6 weeks |
| Functionality of intestinal microbiota | Difference in the levels of intestinal microbiota -derived metabolites in the serum and faeces between the study arms | 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 | 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 | 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 | 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 | Difference in blood and faecal markers of oxidative stress (e.g. glutathione) between the study arms | 6 weeks |
| Concentrations of faecal chromogranins | Difference in faecal levels of chromogranins between the study arms | 6 weeks |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |