Microscopic ColitisNCT03275467
Faecal Microbiota Transplantation in Patients With Microscopic Colitis
A study testing Faecal microbiota transfer (FMT) in people with Microscopic Colitis, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microscopic Colitis
- What is being tested?
- Faecal microbiota transfer (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2017to 31 Oct 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Active MC diagnosis, defined as >3 stools a day from which at least one should be watery
- Willingness to stop budesonide treatment during participation in the trial
- Age: 18-70 years
- Signed informed consent
- High-butyrate producing microbiota in faecal samples
- Age: 18-65 years
Who cannot join
- Previous complicated gastrointestinal surgery
- Malignant disease except non-melanoma skin cancer
- Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- C. difficile or other current gastroenteritis
- Females who are pregnant or breast-feeding
- Severe endometriosis
Show all 44Show fewer
- Antimicrobial treatment 4 weeks prior to first screening visit
- Antimicrobial prophylaxis (eg. acne, urinary tract infection)
- Regular consumption of probiotic products 4 weeks prior to randomization
- Recently diagnosed lactose intolerance (less than 6 months prior to first screening visit)
- Recently diagnosed coeliac disease (less than 6 months prior to first screening visit)
- Regular intake of NSAIDs (non steroidal anti-inflammatory drugs)
- Abuse of alcohol or drugs
- Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
- Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhoea or constipation)
- First degree relative with IBD
- History of or present gastrointestinal malignancy or polyposis
- Recent (gastrointestinal) infection (within last 6 months)
- History of major gastrointestinal surgery (e.g. gastric bypass)
- Eosinophilic disorders of the gastrointestinal tract
- Current communicable disease (e.g. upper respiratory tract infection)
- Malignant disease and/or patients who are receiving systemic anti-neoplastic agents
- Psychiatric diseases (e.g. dementia, depression, schizophrenia, autism, Asperger Syndrome) or other incapacity for adequate cooperation
- Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
- Autoimmune disease and/or patients receiving immunosuppressive medications
- Major relevant allergies (e.g. food allergy, multiple allergies)
- Chronic pain syndromes (e.g. fibromyalgia)
- Chronic fatigue syndrome
- HIV, hepatitis A, B, C or known exposure within the recent 12 months
- Obesity (BMI>30) or metabolic syndrome
- Antimicrobial treatment or prophylaxis within the last 3 months
- Other chronic use of drugs that may affect the microbiome, e.g. proton pump inhibitors
- First degree relative with cardiovascular thrombosis before 50 years of age
- Females who are pregnant or breast-feeding
- Known clinically significant abnormal laboratory values
- Participation in high-risk sexual behaviours
- Abuse of alcohol or drugs
- Tattoo or body piercing within the last 6 months
- Travelling in countries with low hygiene or high infection risk for endemic diarrhoea within the last 6 months
- Positive stool testing for C. difficile, ova and parasites (e.g. Cyclospora, Isospora, Cryptosporidium), enteric pathogens (e.g. enterohaemorrhagic E. coli, Salmonella, Shigella, Yersinia, Campylobacter, Giarda antigen, amoebas)
- Positive stool testing for multiresistant bacteria (e.g. extended-spectrum beta- lactamase (ESBL) producing organisms, multi-resistant Gram-negative bacilli (MRGN) 3 and 4, vancomycin-resistant enterococci (VRE) or methicillin-resistant Staphylococcus aureus (MRSA))
- Calprotectin > 50 μg/g of faeces
- Positive blood testing for HIV, Hepatitis A, B, C, syphilis, Human T-lymphotropic virus (HTLV), cytomegalovirus (CMV) and Epstein Barr Virus (EBV)
- Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Microscopic Colitis
- Being tested
- Faecal microbiota transfer (FMT)
- Medical subject headings
- Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transfer (FMT)Other
Suspended stool from a healthy donor
| Study group | Role | What they receive |
|---|---|---|
| Faecal microbiota transfer (FMT) | Experimental | Suspended stool from a healthy donor Receives: Other: Faecal microbiota transfer (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (10)
Changes in general health and symptom questionnaire scores
SHS
Measured: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in general health questionnaire scores
SF-36
Measured: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in quality of life questionnaire scores
EG-5D-5L
Measured: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in gastrointestinal symptom questionnaire scores
GSRS
Measured: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in hospital and anxiety depression scores
HADS
Measured: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in number and form of bowel movements
1-week-diaries
Measured: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in faecal and mucosal microbiota composition
16S rRNA-based next generation sequencing
Measured: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks
Changes in lymphocyte infiltration
Immunohistochemistry and flow cytometry
Measured: 6 weeks
Changes in subepithelial collagen layer
Immunohistochemistry
Measured: 6 weeks
Changes in immune cell composition of colonic biopsies
Immunohistochemistry and flow cytometry
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 posted7 Sep 2017
- Study start1 Jun 2017
- Primary completion5 Jun 2019
- Study completion31 Oct 2019
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, Professor, MD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275467
- Sponsor's protocol ID
- 2017/072
- Status last verified
- Feb 2020
- First submitted
- 28 Aug 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation in Patients With Microscopic Colitis
- ClinicalTrials.gov ID
- NCT03275467
- Acronym / sponsor ID
- 2017/072
- Conditions
- Microscopic Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Region Örebro County
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 7 Sep 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faecal microbiota transfer (FMT) | Experimental | Other: Faecal microbiota transfer (FMT)Suspended stool from a healthy donor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Active MC diagnosis, defined as >3 stools a day from which at least one should be watery
- Willingness to stop budesonide treatment during participation in the trial
- Age: 18-70 years
- Signed informed consent
Key exclusion criteria (44 listed)
- Previous complicated gastrointestinal surgery
- Malignant disease except non-melanoma skin cancer
- Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- C. difficile or other current gastroenteritis
- Females who are pregnant or breast-feeding
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 |
|---|---|---|
| Faecal microbiota transfer (FMT)Suspended stool from a healthy donor | Other | Faecal microbiota transfer (FMT) |
Primary outcome
Proportion of MC patients in remission six weeks after the first FMT.
Time frame: 6 weeks
Remission is defined as <3 stools per day and a mean of less than one watery stool per day.
10 secondary outcomes
Changes in general health and symptom questionnaire scores
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in general health questionnaire scores
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in quality of life questionnaire scores
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in gastrointestinal symptom questionnaire scores
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in hospital and anxiety depression scores
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in number and form of bowel movements
Time frame: 6 weeks, 8 weeks, 12 weeks, 6 months
Changes in faecal and mucosal microbiota composition
Time frame: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks
Changes in lymphocyte infiltration
Time frame: 6 weeks
Changes in subepithelial collagen layer
Time frame: 6 weeks
Changes in immune cell composition of colonic biopsies
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- 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, Professor, MD 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 Faecal microbiota transfer (FMT) 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 7 inclusion and 44 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: finished, as of the sponsor's last update on 21 Feb 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of MC patients in remission six weeks after the first FMT. (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 Feb 2020.