An interventional study of Faecal microbiota transfer (FMT) in Microscopic Colitis, sponsored by Örebro University, Sweden. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Treatment
Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea, abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized that MC is caused by a deregulated immune response to a luminal agent in predisposed individuals, and an important role of the intestinal microbiota is suggested.
In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10 MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy donor into the intestine of a patient with the aim to restore a disturbed intestinal microbiota.
This will be an intervention pilot study with a 12-week and an optional 6-months follow-up period. It will be investigated if the infusion of suspended stool from healthy donors improves the symptoms of MC patients by restoring their disturbed intestinal microbiota. This procedure is known as faecal microbiota transplantation (FMT).
MC patients (n=10) will be randomised to receive FMT using stool from one of two healthy donors.
At baseline, blood samples and mucosal biopsies will be obtained from the descending colon. In addition, faecal samples will be collected and patients will complete symptom questionnaires. The first FMT will be administered by colonoscopy, FMT 2-3 by enemas. Faecal samples will be collected and questionnaires will be completed at different time points during the study. The patients will be followed-up at 6 weeks, 8 weeks, 12 weeks and 6 months after receiving FMT 1, however, the follow-up after 6 months will be optional. Additional biopsies from the descending colon and blood samples will be collected 6 weeks after the first FMT.
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's enrollment of 10 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.
Inclusion criteria for patients:
Exclusion criteria for patients
Inclusion criteria for donors
Exclusion criteria for donors
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suspended stool from a healthy donor
Other: Faecal microbiota transfer (FMT)
Suspended stool from a healthy donor
Proportion of MC patients in remission six weeks after the first FMT.
Remission is defined as \<3 stools per day and a mean of less than one watery stool per day.
Time frame: 6 weeks
Changes in general health and symptom questionnaire scores
SHS
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in general health questionnaire scores
SF-36
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in quality of life questionnaire scores
EG-5D-5L
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in gastrointestinal symptom questionnaire scores
GSRS
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in hospital and anxiety depression scores
HADS
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in number and form of bowel movements
1-week-diaries
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in faecal and mucosal microbiota composition
16S rRNA-based next generation sequencing
Time frame: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks
Changes in lymphocyte infiltration
Immunohistochemistry and flow cytometry
Time frame: 6 weeks
Changes in subepithelial collagen layer
Immunohistochemistry
Time frame: 6 weeks
Changes in immune cell composition of colonic biopsies
Immunohistochemistry and flow cytometry
Time frame: 6 weeks
Changes in inflammation markers in faecal samples such as faecal calprotectin
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in metabolite profile in faecal samples and blood
Time frame: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; blood: 6 weeks
Changes in gene expression in mucosal biopsies
Time frame: 6 weeks
Changes in barrier function markers in colonic biopsies
Time frame: 6 weeks
Changes in gene expression of butyrate transporters in colonic biopsies
Time frame: 6 weeks
Changes in markers of inflammation and intestinal barrier function in blood
Time frame: 6 weeks
Changes in plasma levels of cardiovascular disease markers and platelet responsiveness and aggregation
Time frame: 6 weeks
Plan to share: No
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Ran from Jun 2017 to primary completion in Jun 2019, 24 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Örebro University, Sweden