Fecal Microbial Transplantation for Ileal Pouch Anal Anastomosis Patients

NCT04336319 | Unknown Phase 2

• 1 other identifier: 0210-18-TLV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Ileal Pouch Anal Anastomosis

Keywords

POUCH; FMT; IPAA

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  2 months

Secondary Outcomes (18)

• efficacy of FMT in pouch patients measured by amount of patients with sustained remission

  12 months

• efficacy of FMT in pouch patients measured by amount of patients with sustained clinical remission

  12 months

• efficacy of FMT in pouch patients measured by reduce of inflammatory markers

  1 month

• efficacy of FMT in pouch patients measured by reduce of inflammatory markers

  2 months

• efficacy of FMT in pouch patients measured by reduce of inflammatory markers

  3 months

Study Arms (1)

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.

Biological: Fecal Microbial Transplantation

Interventions

Fecal Microbial Transplantation BIOLOGICAL

1. 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).

Patients with a confirmed diagnosis of UC who underwent IPAA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Study Officials

• Nitsan Maharshak, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Fliss, PhD

CONTACT

97236974924; naomifl@tlvmc.gov.il

Meytal Kahlon, BA

CONTACT

97236974924; meytalkah@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, R&D Department

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: April 7, 2020
• Study Start: July 5, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)