Ileal Pouch Anal AnastomosisPhase 2NCT04336319
Fecal Microbial Transplantation for Ileal Pouch Anal Anastomosis Patients
A Phase 2 study testing Fecal Microbial Transplantation in people with Ileal Pouch Anal Anastomosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The investigator is hypothesize that an intensive FMT regimen will have superior efficacy the treatment of inflammatory disorders of the pouch (pouchitis and CLDP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileal Pouch Anal Anastomosis
- What is being tested?
- Fecal Microbial Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Jul 2018to 31 Dec 2024
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years with a confirmed diagnosis of UC, who underwent IPAA.
- Endoscopic deterioration or Clinically suspected pouchitis, defined as increased bowel frequency (≥1 stools) relative to post-IPAA baseline (1-3 months post IPAA).
- Clinically stable patients on constant medical regimen throughout the study period. Treated by mesalamine for at least 6 weeks, or steroids at least 2 week, or immunomodulator or biologic at least 12 weeks, medical cannabis at least 2 weeks
Who cannot join
- Diagnosis of Crohn's disease or indeterminate colitis prior to IPAA.
- Positive stool test for parasites or stool culture for pathological bacteria within 60 days prior to enrollment.
- Evidence or history of Clostridium difficile infection within 60 days prior to enrollment.
- Active clinically significant infection (within 60 days of enrollment).
- Active septic pouch complication (e.g., abscess, leak, fistula).
- Post-surgical complication of the pouch (e.g., obstruction, stricture, volvulus, prolapse).
Show all 15Show fewer
- Pregnancy or lactation.
- Unstable or uncontrolled medical disorder (other than suspected pouchitis).
- Inability to give informed consent and complete the study protocol.
- Patient participating in other concomitant clinical intervention trial or who had received any experimental drug within a month prior to enrollment
- Patients received antibiotics within 2 days of enrollment, or are anticipated to use antibiotics or probiotics within the study period (elective surgery or dental care).
- Patients received fecal transplantation in the last 6 months.
- Fever>38°c
- An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC).
- Inability or reluctance to follow through with the study protocol, including (but not exclusive) to: colonoscopy, enema, study visit.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv
Nitsan Maharshak, PhD, 972-3-6947305, nitsanm@tlvmc.gov.il
Nitsan Maharshak, MD
About this study
Official title: An Exploratory Pilot Study Assessing the Efficacy of Fecal Microbial Transplantation for Clinical and Endoscopic Characteristics of Ileal Pouch Anal Anastomosis Patients
The investigator is hypothesize that an intensive FMT regimen will have superior efficacy the treatment of inflammatory disorders of the pouch (pouchitis and CLDP).
Read the detailed description
Study Design:
An open label non-controlled clinical trial.
Study population:
Patients aged 18 to 80 years with a confirmed diagnosis of UC , who underwent IPAA.
Recruitment of the study population:
Patients will be enrolled at the Pouch Clinic of the Tel Aviv Medical Center Inflammatory Bowel Disease Center and at the Department of Colorectal Surgery.
Study procedure:
The study includes six visits to the IBD clinic and phone calls between visits. At baseline, after 8 weeks and after one year of intervention, all patients will undergo pouchoscopy which will be recorded and scored for pouch endoscopic score (Appendix 2). In all three procedures, samples will be collected for future analysis.
According to their endoscopic evaluation at baseline, patients will be categorized as those with an inflamed pouch (cuff, afferent loop, pouch inlet, J-pouch, pouch outlet or pouch mid-line scare) or non inflamed pouch (irritable pouch patients) according to a pouch endoscopic score (PES) and the modified pouch disease activity index endoscopic domain (mPDAI).
Baseline pouchoscopy will include FMT, followed by capsule FMT after 1 week (15 capsules), and after 4 weeks of the study.
All patients will undergo clinical followup at week 4 of the study (mPDAI clinical domain, PCS and PGA) and a second pouchoscopy after 8 weeks.
Clinical follow up will be performed at week 12 of the study, and an annual endoscopic follow up will be preformed at 52 weeks or per personal indication.
Data collection at baseline and follow-up visits will include:
- Clinical assessment:
- Pouch clinical score (PCS)
- mPDAI - clinical domains
- Physician Global Assessment (PGA)
- Pouch endoscopic score (PES)
- Collection of biological samples:
- Stool for analysis of calprotectin level and microbiome
- Urine for analysis of metabolomics
- Serum for analysis of complete blood count (CBC), serum levels of C-Reactive Protein (CRP), albumin, creatinine, liver enzymes
- Tissue samples collected during pouchoscopy at baseline and followup - samples will be collected from the cuff, pouch body and pouch inlet.
- Anthropocentric measures will be assessed (weight, height)
- Complete study questionnaires:
- A validated lifestyle and food frequency questionnaire (FFQ)
- Three day food diary
- Quality of life questionnaire (SF-12)
- Patient-reported outcomes (PRO) Measurement Information System (PROMIS)
- Life style questionnaire
Safety assessments:
will include history taking, vital signs, physical examinations and laboratory analysis during each visit. Patients who discontinue the trial treatment will continue to be followed as per protocol. Follow-up will be discontinued in patients who withdraw informed consent or are lost for follow-up. All adverse events will be registered as: unrelated, possible related, likely related or definitely related to the intervention. SAEs will be communicated immediately to the IRB.
- Conditions
- Ileal Pouch Anal Anastomosis
- Being tested
- Fecal Microbial Transplantation
- Keywords
- POUCH, FMT, IPAA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationBiological
- At baseline, the fecal fluid from 3 different donors, 150 ml, will be delivered via pouchoscopy after which the patient will roll in to the right lateral position and stay in that position for at least 15 minutes. Prior to the procedure, the patient will fast for 12 hours and preform two fleet enemas as preperation.
- FMT at 7 days and 4 weeks will be delivered via ingestion of 15 capsules containing 650 µL of fecal fluid from 3 different donors (the same three donors as at baseline).
| Study group | Role | What they receive |
|---|---|---|
| Patients with a confirmed diagnosis of UC who underwent IPAA | Experimental | Patients who meet inclusion criteria will be enrolled and will sign an informed consent form. The study includes six visits to the IBD clinic and phone calls between visits. Receives: Biological: Fecal Microbial Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of fecal microbial transplantation in pouch patients by disease exacerbations
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by rate of patients with disease exacerbations
Measured: 1 year
safety of fecal microbial transplantation in pouch patients by hospitalizations of patients
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require hospitalizations
Measured: 1 year
safety of fecal microbial transplantation in pouch patients by patients requiring surgery
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require surgery
Measured: 1 year
efficacy of FMT in pouch patients measured by mPDAI decrease
By preforming a pouchoscopy, mPDAI (modified pouchitis disease activity index) will be used to assess decrease of ≤1 in mPDAI in condition of the pouch comparing to baseline
Measured: 2 months
efficacy of FMT in pouch patients measured by clinical remission
efficacy of FMT in pouch patients will be measured by the amount of patients with clinical remission measured by mPDAI clinical score <3
Measured: 2 months
Secondary outcomes (18)
efficacy of FMT in pouch patients measured by amount of patients with sustained remission
Sustained remission as defined by mPDAI endoscopic score ≤ 1 or mPDAI endoscopic and clinical ≤ 5
Measured: 12 months
efficacy of FMT in pouch patients measured by amount of patients with sustained clinical remission
Sustained remission as defined by mPDAI clinical <3
Measured: 12 months
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Reduction in inflammatory markers (calprotectin and CRP)
Measured: 1 month
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Reduction in inflammatory markers (calprotectin and CRP)
Measured: 2 months
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Reduction in inflammatory markers (calprotectin and CRP)
Measured: 3 months
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Reduction in inflammatory markers (calprotectin and CRP)
Measured: 12 months
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Reduction in PGA (physical global assessment) comparing to baseline
Measured: 1 month
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Reduction in PGA (physical global assessment) comparing to previous assessments
Measured: 2 months
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Reduction in PGA (physical global assessment) comparing to previous assessments
Measured: 3 months
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Reduction in PGA (physical global assessment) comparing to previous assessments
Measured: 12 months
efficacy of FMT in pouch patients measured by improvement of life quality
efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement
Measured: 1 month
efficacy of FMT in pouch patients measured by improvement of life quality
efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement
Measured: 2 months
efficacy of FMT in pouch patients measured by improvement of life quality
efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement
Measured: 3 months
efficacy of FMT in pouch patients measured by improvement of life quality
efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement
Measured: 12 months
efficacy of FMT in pouch patients measured by improvement of nutritional status
improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25
Measured: 1 month
efficacy of FMT in pouch patients measured by improvement of nutritional status
improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25
Measured: 2 months
efficacy of FMT in pouch patients measured by improvement of nutritional status
improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25
Measured: 3 months
efficacy of FMT in pouch patients measured by improvement of nutritional status
improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25
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 posted7 Apr 2020
- Study start5 Jul 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileal Pouch Anal AnastomosisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Nitsan Maharshak, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336319
- Sponsor's protocol ID
- 0210-18-TLV
- Status last verified
- Apr 2020
- First submitted
- 4 Jun 2019
- Last updated
- 7 Apr 2020
- Results posted
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pilot Study Assessing the Efficacy of Fecal Microbial Transplantation for Clinical and Endoscopic Characteristics of Ileal Pouch Anal Anastomosis Patients
- ClinicalTrials.gov ID
- NCT04336319
- Acronym / sponsor ID
- 0210-18-TLV
- Conditions
- Ileal Pouch Anal Anastomosis
- Keywords
- POUCH, FMT, IPAA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Apr 2020 (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.
The investigator is hypothesize that an intensive FMT regimen will have superior efficacy the treatment of inflammatory disorders of the pouch (pouchitis and CLDP).
Detailed description
Study Design:
An open label non-controlled clinical trial.
Study population:
Patients aged 18 to 80 years with a confirmed diagnosis of UC , who underwent IPAA.
Recruitment of the study population:
Patients will be enrolled at the Pouch Clinic of the Tel Aviv Medical Center Inflammatory Bowel Disease Center and at the Department of Colorectal Surgery.
Study procedure:
The study includes six visits to the IBD clinic and phone calls between visits. At baseline, after 8 weeks and after one year of intervention, all patients will undergo pouchoscopy which will be recorded and scored for pouch endoscopic score (Appendix 2). In all three procedures, samples will be collected for future analysis.
According to their endoscopic evaluation at baseline, patients will be categorized as those with an inflamed pouch (cuff, afferent loop, pouch inlet, J-pouch, pouch outlet or pouch mid-line scare) or non inflamed pouch (irritable pouch patients) according to a pouch endoscopic score (PES) and the modified pouch disease activity index endoscopic domain (mPDAI).
Baseline pouchoscopy will include FMT, followed by capsule FMT after 1 week (15 capsules), and after 4 weeks of the study.
All patients will undergo clinical followup at week 4 of the study (mPDAI clinical domain, PCS and PGA) and a second pouchoscopy after 8 weeks.
Clinical follow up will be performed at week 12 of the study, and an annual endoscopic follow up will be preformed at 52 weeks or per personal indication.
Data collection at baseline and follow-up visits will include:
- Clinical assessment:
- Pouch clinical score (PCS)
- mPDAI - clinical domains
- Physician Global Assessment (PGA)
- Pouch endoscopic score (PES)
- Collection of biological samples:
- Stool for analysis of calprotectin level and microbiome
- Urine for analysis of metabolomics
- Serum for analysis of complete blood count (CBC), serum levels of C-Reactive Protein (CRP), albumin, creatinine, liver enzymes
- Tissue samples collected during pouchoscopy at baseline and followup - samples will be collected from the cuff, pouch body and pouch inlet.
- Anthropocentric measures will be assessed (weight, height)
- Complete study questionnaires:
- A validated lifestyle and food frequency questionnaire (FFQ)
- Three day food diary
- Quality of life questionnaire (SF-12)
- Patient-reported outcomes (PRO) Measurement Information System (PROMIS)
- Life style questionnaire
Safety assessments:
will include history taking, vital signs, physical examinations and laboratory analysis during each visit. Patients who discontinue the trial treatment will continue to be followed as per protocol. Follow-up will be discontinued in patients who withdraw informed consent or are lost for follow-up. All adverse events will be registered as: unrelated, possible related, likely related or definitely related to the intervention. SAEs will be communicated immediately to the IRB.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a confirmed diagnosis of UC who underwent IPAA | Experimental | Biological: Fecal Microbial TransplantationPatients who meet inclusion criteria will be enrolled and will sign an informed consent form. The study includes six visits to the IBD clinic and phone calls between visits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 80 years with a confirmed diagnosis of UC, who underwent IPAA.
- Endoscopic deterioration or Clinically suspected pouchitis, defined as increased bowel frequency (≥1 stools) relative to post-IPAA baseline (1-3 months post IPAA).
- Clinically stable patients on constant medical regimen throughout the study period. Treated by mesalamine for at least 6 weeks, or steroids at least 2 week, or immunomodulator or biologic at least 12 weeks, medical cannabis at least 2 weeks
Key exclusion criteria (15 listed)
- Diagnosis of Crohn's disease or indeterminate colitis prior to IPAA.
- Positive stool test for parasites or stool culture for pathological bacteria within 60 days prior to enrollment.
- Evidence or history of Clostridium difficile infection within 60 days prior to enrollment.
- Active clinically significant infection (within 60 days of enrollment).
- Active septic pouch complication (e.g., abscess, leak, fistula).
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 |
|---|---|---|
| Fecal Microbial Transplantation1. At baseline, the fecal fluid from 3 different donors, 150 ml, will be delivered via pouchoscopy after which the patient will roll in to the right lateral position and stay in that position for at least 15 minutes. Prior to the procedure, the patient will fast for 12 hours and preform two fleet enemas as preperation. 2. FMT at 7 days and 4 weeks will be delivered via ingestion of 15 capsules containing 650 µL of fecal fluid from 3 different donors (the same three donors as at baseline). | Biological | Patients with a confirmed diagnosis of UC who underwent IPAA |
Primary outcome
safety of fecal microbial transplantation in pouch patients by disease exacerbations
Time frame: 1 year
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by rate of patients with disease exacerbations
safety of fecal microbial transplantation in pouch patients by hospitalizations of patients
Time frame: 1 year
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require hospitalizations
safety of fecal microbial transplantation in pouch patients by patients requiring surgery
Time frame: 1 year
determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require surgery
efficacy of FMT in pouch patients measured by mPDAI decrease
Time frame: 2 months
By preforming a pouchoscopy, mPDAI (modified pouchitis disease activity index) will be used to assess decrease of ≤1 in mPDAI in condition of the pouch comparing to baseline
efficacy of FMT in pouch patients measured by clinical remission
Time frame: 2 months
efficacy of FMT in pouch patients will be measured by the amount of patients with clinical remission measured by mPDAI clinical score <3
18 secondary outcomes
efficacy of FMT in pouch patients measured by amount of patients with sustained remission
Time frame: 12 months
efficacy of FMT in pouch patients measured by amount of patients with sustained clinical remission
Time frame: 12 months
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Time frame: 1 month
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Time frame: 2 months
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Time frame: 3 months
efficacy of FMT in pouch patients measured by reduce of inflammatory markers
Time frame: 12 months
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Time frame: 1 month
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Time frame: 2 months
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Time frame: 3 months
efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment)
Time frame: 12 months
efficacy of FMT in pouch patients measured by improvement of life quality
Time frame: 1 month
efficacy of FMT in pouch patients measured by improvement of life quality
Time frame: 2 months
efficacy of FMT in pouch patients measured by improvement of life quality
Time frame: 3 months
efficacy of FMT in pouch patients measured by improvement of life quality
Time frame: 12 months
efficacy of FMT in pouch patients measured by improvement of nutritional status
Time frame: 1 month
efficacy of FMT in pouch patients measured by improvement of nutritional status
Time frame: 2 months
efficacy of FMT in pouch patients measured by improvement of nutritional status
Time frame: 3 months
efficacy of FMT in pouch patients measured by improvement of nutritional status
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
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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.
Nitsan Maharshak, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbial Transplantation in people with Ileal Pouch Anal Anastomosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Apr 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi Fliss, PhD (97236974924, naomifl@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of fecal microbial transplantation in pouch patients by disease exacerbations (time frame: 1 year). The study lists 5 primary outcomes in all. 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 7 Apr 2020.