Status:
UNKNOWN
Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Pouchitis
Crhon's Disease Like of the Pouch
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for patients with ulcerative colitis (UC) who require surgery. Inflammation of the ileal pouch ...
Detailed Description
Hypothesis (es) and Aims: 1. The investigator aims to evaluate the natural development of the pouch microenvironment among post-IPAA patients over one year of follow-up, and associate dietary intake ...
Eligibility Criteria
Inclusion
- Post-IPAA for ulcerative colitis ≤3 months post-opp OR post -IPAA for UC 1.1 Active pouchitis defined as: 1.1.1 ≥5 points modified Pouch disease activity index (mPDAI), and one of the following: 1.1.2 Pouchoscopy demonstrating lesions in the ileum/jejunum/afferent pouch loop of the pouch, clinical PDAI\>2 points 1.1.3 MR/CTEnterography with evidence of inflammation of the pouch 1.1.4 Fecal calprotectin\>250 µg/gr
- Lack of obstructive symptomes for 8 weeks
- Stable medications and doses:
- 1 Immunomodulatory and biologics at least 8 weeks 3.2 Mesalamine at least 4 weeks 3.3 Medical cannabis at least 2 weeks 3.4 Budesonide dependent allowed if patients are active and budesonide dose is ≤6 mg, VIVOMIX probiotics allowed). Use of Antibiotics / Budesonide \<6 mg at baseline\*.
- \*Patients treated with steroids or antibiotics at baseline will be included in the study and be allowed to continue the study if they treated with a stable dose throughout at least 4 weeks. After 4 weeks if the trial, if they present clinical improvement, according to the judgment of the study physician, dose may be gradually reduced for the remaining trial without exclusion.
- Informed consent and ability to complete the study protocol.
Exclusion
- Pregnancy
- Use of systemic steroids / Budesonide \>6 mg at baseline.
- Currently active systemic diseases such as spondylo-arthropathies, collagen vascular disease, renal failure, hepatitis or heart disease
- Positive Stool culture, stool parasites or clostridium difficile toxin or alternative C- Difficile test.
- Evidence of bowel stricture
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04327219
Start Date
April 1 2020
End Date
April 1 2023
Last Update
February 7 2022
Active Locations (1)
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1
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel