PouchitisNCT04820413
Faecal Microbiota Transplantation From Normal Pouch Function Donor 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 1 site in Denmark.
Trial summary
Patients with chronic 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?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 15 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 3 months
Who cannot join
- Immunosuppression
- Pregnancy or breastfeeding
- 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
1 site in 1 country.
Denmark1 site
Department of Gastrointestinal Surgery, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: Faecal Microbiota Transplantation Using Stool From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis
Patients with chronic 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. The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Studies show that patients with pouchitis have an altered composition of the gut microbiota compared to healthy individuals and patients with a pouch without inflammation. 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 to chronic pouchitis has been investigated in several clinical trials with mixed results. It is however still uncertain if faecal microbiota transplantation using stool from healthy individuals with a colon is optimal, or if stool from patient with a normally functioning pouch should be used.
The study primary aims to investigate if transplantation of faeces from patient with a normal pouch function can induce clinical remission in patients with chronic pouchitis.
Read the detailed description
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT with stool from a normal function pouch patient has a clinical effect by inducing clinical remission in patients with chronic pouchitis.
Objective of the study:
The aim of the trial is to investigate if transplantation (FMT) of faeces from a patient with a normally functioning pouch can induce clinical remission in patients with chronic pouchitis.
Study design:
The project is designed as a single-center, open-label, treatment study.
Methods:
Faecal microbiota transplantation is performed with faeces from a donor with a normally functioning pouch. Potential donors are recruited from the Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark. 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 faeces from the faecal donor.
Initial before the treatment with FMT, the patient will be invited for serum analysis (CRP, leukocytes) and faecal analysis (calprotectin, C.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 contain faeces from the faecal donor. 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 after additional 1,3, 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
- 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
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Not described Receives: Other: Faecal microbiota transplantation |
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 (2)
Number of patients achieving clinical response assessed by PDAI
Clinical response is defined as reduction of PDAI score >2
Measured: 4 weeks
Engraftment of the donor microbiota in the patients
Assessed by beta-diversity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Mar 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT04820413
- Sponsor's protocol ID
- MicroPouch-NP
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2021
- Last updated
- 13 Jul 2022
- 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 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation Using Stool From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis
- ClinicalTrials.gov ID
- NCT04820413
- Acronym / sponsor ID
- MicroPouch-NP
- Conditions
- Pouchitis, Inflammatory Bowel Diseases, Ulcerative Colitis
- Keywords
- FMT, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of SurgeryUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 29 Mar 2021 (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 chronic 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. The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Studies show that patients with pouchitis have an altered composition of the gut microbiota compared to healthy individuals and patients with a pouch without inflammation. 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 to chronic pouchitis has been investigated in several clinical trials with mixed results. It is however still uncertain if faecal microbiota transplantation using stool from healthy individuals with a colon is optimal, or if stool from patient with a normally functioning pouch should be used.
The study primary aims to investigate if transplantation of faeces from patient with a normal pouch function can induce clinical remission in patients with chronic pouchitis.
Detailed description
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut microbiota using FMT with stool from a normal function pouch patient has a clinical effect by inducing clinical remission in patients with chronic pouchitis.
Objective of the study:
The aim of the trial is to investigate if transplantation (FMT) of faeces from a patient with a normally functioning pouch can induce clinical remission in patients with chronic pouchitis.
Study design:
The project is designed as a single-center, open-label, treatment study.
Methods:
Faecal microbiota transplantation is performed with faeces from a donor with a normally functioning pouch. Potential donors are recruited from the Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark. 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 faeces from the faecal donor.
Initial before the treatment with FMT, the patient will be invited for serum analysis (CRP, leukocytes) and faecal analysis (calprotectin, C.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 contain faeces from the faecal donor. 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 after additional 1,3, 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Other: Faecal microbiota transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 3 months
Key exclusion criteria (7 listed)
- Immunosuppression
- Pregnancy or breastfeeding
- 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 |
Primary outcome
Number of patients achieving clinical remission assessed by PDAI
Time frame: 4 weeks
Clinical remission is defined as PDAI<7
2 secondary outcomes
Number of patients achieving clinical response assessed by PDAI
Time frame: 4 weeks
Engraftment of the donor microbiota in the patients
Time frame: 4 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 13 Jul 2022.
- 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
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 transplantation in people with Pouchitis and Inflammatory Bowel Diseases, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site 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 4 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: finished, as of the sponsor's last update on 13 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 1 site 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. 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?
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?
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 13 Jul 2022.