PouchitisMicroPouchNCT04100291
Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
A study testing Faecal microbiota transplantation in people with Pouchitis and Inflammatory Bowel Diseases, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 2 sites in Denmark.
Trial summary
Patients with the chronic bowel disease pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the management of the chronic inflammatory bowel disease, ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pouchitis, Inflammatory Bowel Diseases, Ulcerative Colitis
- What is being tested?
- Faecal microbiota transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2019to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age with a J-pouch
- PDAI ≥ 7
- Established diagnosis of chronic pouchitis (≥3 times of pouchitis within the last year, symptoms more than 4 weeks despite antibiotic treatment)
- Antibiotic treatment for pouchitis (ciprofloxacin and/or metronidazole) within the last year
- Not pregnant or breastfeeding
Who cannot join
- Immunosuppression
- Pregnancy
- Evidence of intestinal pathogen bacteria in the stool at inclusion visit
- Any severe or newly diagnosed concomitant cardiovascular, hepatic, intestinal, renal, endocrine, pulmonary, dental disease with inflammation or psychiatric disorder, which, in the opinion of the investigator, might have an influence on the patient's compliance or the interpretation of the results
- Probiotic intake within the last 2 weeks prior to study intervention
- Participation in another clinical trial within the previous 30 days before baseline
- Serious food allergies with earlier anaphylactic reactions
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Gastrointestinal Surgery, Aalborg University Hospital
Aalborg, 9000
Department of Medical Gastroenterology, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Official title: The Effect of Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis: A Multicentre, Placebo-controlled, Randomized, Double Blinded Trial
Patients with the chronic bowel disease pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the management of the chronic inflammatory bowel disease, ulcerative colitis. Chronic pouchitis is a rare disease with a prevalence in Denmark of <1.8 per 10,000 people, mostly younger people (<50 years). The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Recent studies show that patients with pouchitis have an altered composition of the gut flora, called microbiota, compared to healthy individuals. As shown by several studies, faecal microbiota transplantation (FMT) with administration of faeces from healthy donors can alter the microbiota. Treatment with faecal microbiota transplantation is today known to be the ultimate treatment for antibiotic resistant recurrent bowel infection with the bacteria Clostridium difficile. It is however still uncertain if faecal microbiota transplantation can be used to the treatment of chronic pouchitis.
The study primary aims to investigate if transplantation of faeces from healthy donors administrated as enemas to patients with chronic pouchitis is superior to placebo for the treatment of pouchitis.
The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study. A positive result from the project will result in an improved treatment to pouchitis patients. Moreover, repeated long-lasting broad-spectrum treatments with antibiotic, which carry a high risk of antibiotic resistance in the society, will be avoided.
Read the detailed description
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT has a clinical effect by inducing clinical remission in patients with chronic pouchitis.
Objective of the study:
The aim of the MicroPouch-trial is to investigate if transplantation (FMT) of faeces from healthy donors to patients with chronic pouchitis is clinical significant to placebo for the treatment of pouchitis.
Study design:
The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study.
Methods:
Faecal microbiota transplantation is performed with faeces from healthy donors. Potential donors are recruited from the Danish Blood Bank. They are screened for a various of infectious diseases by serum analysis (haematology, inflammation, liver and kidney function, HIV, Hepatitis, Cytomegalovirus, Epstein Barr virus and HbA1c) and faeces analysis (calprotectin, Clostridium difficile (PCR), enteric pathogenic bacteria and antibiotic-resistant bacteria, parasites, cysts, and viruses). Furthermore, the potential donors will complete an extensive questionnaire regarding general health, risk factors and medical history, before they can be included as faecal donors in the project. The screening procedure is based on recommendation from the European FMT Working Group.
The transplantation is performed by enemas, which contain either faeces from the faecal donors or placebo.
Initial before the treatment with either donor faeces or placebo, the patient will be invited for serum analysis (CRP, leukocytes) and faecal analysis (calprotectin, Clostridium difficile, enteric pathogenic bacteria), followed by a pouchoscopy with collection of biopsies. Materials from serum- and faecal analysis and biopsies will be stored for later analysis purpose. The patient will further complete questionnaires concerning symptoms and quality of life. The stage of disease will be evaluated based on the acknowledged questionnaire for pouchitis called Pouchitis Disease Activity Index (PDAI) score.
The treatment begins after all the initial examinations, and the patient will be treated during one month. The treatment consists of daily enema infusion, which either contain faeces from the faecal donors or placebo. During the treatment, the patient will daily record symptoms related to pouchitis (diarrhea, abdominal pain, bleeding per rectum, fever, general discomfort) and possible adverse effects to the treatment.
At the end of treatment, the patient will meet to a follow-up examination including serum analysis (CRP, leukocytes) and faecal analysis (calprotectin), pouchoscopy incl. biopsies, and the questionnaires applied before the treatment. Materials from serum- and faecal analysis and biopsies will be stored for later analysis.
The patient will be followed up with serum- and faecal analysis and pouchoscopy after additional 6 and 12 months to evaluate the long term effect of the transplantation. The consumption of antibiotics during the first year will be recorded. In case of lacking effect of faecal microbiota transplantation, the patient is offered standard antibiotic treatment for pouchitis, and will leave the study.
Faecal samples and biopsies collected in the study will be analyzed for the composition of the microbiota.
- Conditions
- Pouchitis, Inflammatory Bowel Diseases, Ulcerative Colitis
- Being tested
- Faecal microbiota transplantation, Placebo
- Keywords
- FMT, Microbiota
- Medical subject headings
- Pouchitis, Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transplantationOther
FMT by daily enema with donor faeces
PlaceboOther
Placebo by daily enema with placebo mixture
| Study group | Role | What they receive |
|---|---|---|
| FMT | Active comparator | Faecal microbiota transplantation Receives: Other: Faecal microbiota transplantation |
| Placebo | Placebo comparator | Placebo mixture Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients achieving clinical remission assessed by PDAI
Clinical remission is defined as PDAI<7
Measured: 4 weeks
Secondary outcomes (6)
Number of patients achieving clinical response assessed by PDAI
Clinical response is defined as reduction of PDAI score >2
Measured: 4 weeks
Number of patients experience improvement in quality of life assessed by the patient-reported questionnaire SIBDQ
Measured: 4 weeks
Number of patients relapsing
Relapse is defined as need for antibiotic treatment for pouchitis
Measured: 12 months
Number of patients with treatment-related adverse events in the FMT group compared to the placebo group
Measured: 12 months
Increase of the faecal microbiota biodiversity assessed by alpha-diversity
Measured: 12 months
Engraftment of the donor microbiota in the patients assessed by beta-diversity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Jul 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: Covid-19 inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PouchitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital
- Investigators
- Ole Thorlacius-Ussing, Professor, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100291
- Sponsor's protocol ID
- MicroPouch
- Acronym
- MicroPouch
- Status last verified
- Jul 2022
- First submitted
- 12 Sep 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
PubMed 28087657Jakobsen SS, Kousgaard SJ, Cold F, Halkjaer SI, Petersen AM, Kjeldsen J, Hansen JM, Thorlacius-Ussing O. The effect of fecal microbiota transplantation on quality of life in patients with chronic pouchitis: a post hoc analysis of the MicroPouch trial. Ther Adv Gastroenterol. 2026 May 31;19:17562848261452497. doi: 10.1177/17562848261452497. eCollection 2026.
PubMed 42232317Kousgaard SJ, Cold F, Halkjaer SI, Petersen AM, Kjeldsen J, Hansen JM, Dall SM, Albertsen M, Nielsen HL, Kirk KF, Duch K, Sonderkaer M, Thorlacius-Ussing O. The Effect of Non-pooled Multidonor Faecal Microbiota Transplantation for Inducing Clinical Remission in Patients with Chronic Pouchitis: Results from a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [MicroPouch]. J Crohns Colitis. 2024 Nov 4;18(11):1753-1766. doi: 10.1093/ecco-jcc/jjae066.
PubMed 38708959
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis: A Multicentre, Placebo-controlled, Randomized, Double Blinded Trial
- ClinicalTrials.gov ID
- NCT04100291
- Acronym / sponsor ID
- MicroPouch / MicroPouch
- Conditions
- Pouchitis, Inflammatory Bowel Diseases, Ulcerative Colitis
- Keywords
- FMT, Microbiota
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 inclusion difficulties
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of SurgeryUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 24 Sep 2019 (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.
Patients with the chronic bowel disease pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the management of the chronic inflammatory bowel disease, ulcerative colitis. Chronic pouchitis is a rare disease with a prevalence in Denmark of <1.8 per 10,000 people, mostly younger people (<50 years). The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Recent studies show that patients with pouchitis have an altered composition of the gut flora, called microbiota, compared to healthy individuals. As shown by several studies, faecal microbiota transplantation (FMT) with administration of faeces from healthy donors can alter the microbiota. Treatment with faecal microbiota transplantation is today known to be the ultimate treatment for antibiotic resistant recurrent bowel infection with the bacteria Clostridium difficile. It is however still uncertain if faecal microbiota transplantation can be used to the treatment of chronic pouchitis.
The study primary aims to investigate if transplantation of faeces from healthy donors administrated as enemas to patients with chronic pouchitis is superior to placebo for the treatment of pouchitis.
The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study. A positive result from the project will result in an improved treatment to pouchitis patients. Moreover, repeated long-lasting broad-spectrum treatments with antibiotic, which carry a high risk of antibiotic resistance in the society, will be avoided.
Detailed description
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT has a clinical effect by inducing clinical remission in patients with chronic pouchitis.
Objective of the study:
The aim of the MicroPouch-trial is to investigate if transplantation (FMT) of faeces from healthy donors to patients with chronic pouchitis is clinical significant to placebo for the treatment of pouchitis.
Study design:
The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study.
Methods:
Faecal microbiota transplantation is performed with faeces from healthy donors. Potential donors are recruited from the Danish Blood Bank. They are screened for a various of infectious diseases by serum analysis (haematology, inflammation, liver and kidney function, HIV, Hepatitis, Cytomegalovirus, Epstein Barr virus and HbA1c) and faeces analysis (calprotectin, Clostridium difficile (PCR), enteric pathogenic bacteria and antibiotic-resistant bacteria, parasites, cysts, and viruses). Furthermore, the potential donors will complete an extensive questionnaire regarding general health, risk factors and medical history, before they can be included as faecal donors in the project. The screening procedure is based on recommendation from the European FMT Working Group.
The transplantation is performed by enemas, which contain either faeces from the faecal donors or placebo.
Initial before the treatment with either donor faeces or placebo, the patient will be invited for serum analysis (CRP, leukocytes) and faecal analysis (calprotectin, Clostridium difficile, enteric pathogenic bacteria), followed by a pouchoscopy with collection of biopsies. Materials from serum- and faecal analysis and biopsies will be stored for later analysis purpose. The patient will further complete questionnaires concerning symptoms and quality of life. The stage of disease will be evaluated based on the acknowledged questionnaire for pouchitis called Pouchitis Disease Activity Index (PDAI) score.
The treatment begins after all the initial examinations, and the patient will be treated during one month. The treatment consists of daily enema infusion, which either contain faeces from the faecal donors or placebo. During the treatment, the patient will daily record symptoms related to pouchitis (diarrhea, abdominal pain, bleeding per rectum, fever, general discomfort) and possible adverse effects to the treatment.
At the end of treatment, the patient will meet to a follow-up examination including serum analysis (CRP, leukocytes) and faecal analysis (calprotectin), pouchoscopy incl. biopsies, and the questionnaires applied before the treatment. Materials from serum- and faecal analysis and biopsies will be stored for later analysis.
The patient will be followed up with serum- and faecal analysis and pouchoscopy after additional 6 and 12 months to evaluate the long term effect of the transplantation. The consumption of antibiotics during the first year will be recorded. In case of lacking effect of faecal microbiota transplantation, the patient is offered standard antibiotic treatment for pouchitis, and will leave the study.
Faecal samples and biopsies collected in the study will be analyzed for the composition of the microbiota.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT | Active comparator | Other: Faecal microbiota transplantationFaecal microbiota transplantation |
| Placebo | Placebo comparator | Other: PlaceboPlacebo mixture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age with a J-pouch
- PDAI ≥ 7
- Established diagnosis of chronic pouchitis (≥3 times of pouchitis within the last year, symptoms more than 4 weeks despite antibiotic treatment)
- Antibiotic treatment for pouchitis (ciprofloxacin and/or metronidazole) within the last year
- Not pregnant or breastfeeding
Key exclusion criteria (7 listed)
- Immunosuppression
- Pregnancy
- Evidence of intestinal pathogen bacteria in the stool at inclusion visit
- Any severe or newly diagnosed concomitant cardiovascular, hepatic, intestinal, renal, endocrine, pulmonary, dental disease with inflammation or psychiatric disorder, which, in the opinion of the investigator, might have an influence on the patient's compliance or the interpretation of the results
- Probiotic intake within the last 2 weeks prior to study intervention
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 transplantationFMT by daily enema with donor faeces | Other | FMT |
| PlaceboPlacebo by daily enema with placebo mixture | Other | Placebo |
Primary outcome
Number of patients achieving clinical remission assessed by PDAI
Time frame: 4 weeks
Clinical remission is defined as PDAI<7
6 secondary outcomes
Number of patients achieving clinical response assessed by PDAI
Time frame: 4 weeks
Number of patients experience improvement in quality of life assessed by the patient-reported questionnaire SIBDQ
Time frame: 4 weeks
Number of patients relapsing
Time frame: 12 months
Number of patients with treatment-related adverse events in the FMT group compared to the placebo group
Time frame: 12 months
Increase of the faecal microbiota biodiversity assessed by alpha-diversity
Time frame: 12 months
Engraftment of the donor microbiota in the patients assessed by beta-diversity
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Covid-19 inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 28087657Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
- Derived from this study: PubMed 42232317Jakobsen SS, Kousgaard SJ, Cold F, Halkjaer SI, Petersen AM, Kjeldsen J, Hansen JM, Thorlacius-Ussing O. The effect of fecal microbiota transplantation on quality of life in patients with chronic pouchitis: a post hoc analysis of the MicroPouch trial. Ther Adv Gastroenterol. 2026 May 31;19:17562848261452497. doi: 10.1177/17562848261452497. eCollection 2026.
- Derived from this study: PubMed 38708959Kousgaard SJ, Cold F, Halkjaer SI, Petersen AM, Kjeldsen J, Hansen JM, Dall SM, Albertsen M, Nielsen HL, Kirk KF, Duch K, Sonderkaer M, Thorlacius-Ussing O. The Effect of Non-pooled Multidonor Faecal Microbiota Transplantation for Inducing Clinical Remission in Patients with Chronic Pouchitis: Results from a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [MicroPouch]. J Crohns Colitis. 2024 Nov 4;18(11):1753-1766. doi: 10.1093/ecco-jcc/jjae066.
- 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.
Ole Thorlacius-Ussing, Professor study chair
Aalborg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal microbiota transplantation in people with Pouchitis and Inflammatory Bowel Diseases, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 2 sites in Denmark.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study was stopped early (reason given: Covid-19 inclusion difficulties). Results are not available in the source record.
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?
Number of patients achieving clinical remission assessed by PDAI (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100291, which also lists 3 linked publications.
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 14 Jul 2022.