An interventional study of Dietary fibre and Placebo compound in Microscopic Colitis, sponsored by Örebro University, Sweden. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Basic science
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.
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's planned enrollment of 40 is below the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.
Browse Colitis, Microscopic studies →Örebro University, Sweden is the lead sponsor of 86 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Butyrate-promoting dietary fibre
Dietary Supplement: Dietary fibre
Placebo compound
Dietary Supplement: Placebo compound
Dietary fibre as a powder, 24 g per day for 6 weeks
Maltodextrin powder, 24 g per day for 6 weeks
Colonic permeability in vivo
Difference in urinary sucralose/erythritol excretion ratio between the study arms
Time frame: 6 weeks
Small intestinal permeability in vivo
Difference in urinary lactulose/rhamnose excretion ratio between the study arms
Time frame: 6 weeks
Colonic permeability ex vivo in Ussing chambers
Difference in the translocation of FITC-labeled dextran and horseradish peroxidase between the study arms
Time frame: 6 weeks
Concentrations of intestinal fatty-acid binding protein
Difference in plasma concentrations of intestinal fatty-acid binding protein between the study arms
Time frame: 6 weeks
Concentrations of lipopolysaccharide-binding protein
Difference in plasma levels of lipopolysaccharide-binding protein between the study arms
Time frame: 6 weeks
Concentratios of faecal calprotectin
Difference in faecal levels of calprotectin between the study arms
Time frame: 6 weeks
Concentrations of faecal myeloperoxidase
Difference in faecal levels of myeloperoxidase between the study arms
Time frame: 6 weeks
Concentrations of high-sensitive C-reactive protein
Difference in plasma levels of high-sensitive C-reactive protein between the study arms
Time frame: 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
Time frame: 6 weeks
Composition of intestinal microbiota
Difference in the composition of intestinal microbiota between the study arms
Time frame: 6 weeks
Functionality of intestinal microbiota
Difference in the levels of intestinal microbiota -derived metabolites in the serum and faeces between the study arms
Time frame: 6 weeks
Faecal output measured by a daily diary
Difference in the number of diarrhoeal stools per day between the study arms
Time frame: 6 weeks
Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 6 weeks
Concentrations of faecal chromogranins
Difference in faecal levels of chromogranins between the study arms
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Örebro University, Sweden