Status:
UNKNOWN
Fecal Microbial Transplantation for Ileal Pouch Anal Anastomosis Patients
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Ileal Pouch Anal Anastomosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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).
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04336319
Start Date
July 5 2018
End Date
December 31 2024
Last Update
April 7 2020
Active Locations (1)
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1
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel