Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients

NCT04327219 | Unknown

• 1 other identifier: TASMC-0637-19-CTIL
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 (pouchitis) occurs in up to 60% of pouch patients. Although, pouchitis patients are former UC patients, the disease occurs in the small intestine, similarly to Crohn's disease (CD). Further, the disease can be clinically similar to CD, involving the proximal gastro-intestinal tract and causing strictures, fistula, or perianal disease. The Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. The diet also provides dietary components that may favor species (especially SCFA producers) which appear to be deficient in CD. The investigator therefore aims to examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in a cohort of adults suffering from active pouchitis.

Conditions

Pouchitis; Crhon's Disease Like of the Pouch

Keywords

pouchitis; crohn's disease of the pouch; crohn's disease exclusion diet; CDED; ileal pouch anal anastomosis; IPAA

Outcome Measures

Primary Outcomes (1)

• steroid free clinical remission

  defined as Clinical pouchitis disease activity index ("cPDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) sub score≤2 for pouchitis patients

  week 6

Secondary Outcomes (14)

• Steroid free clinical remission

  week 12

• Maintenance of clinical remission

  week 24

• clinical and endoscopic remission

  week 12

• clinical and endoscopic remission

  week 24

• Clinical response

  week 6

Study Arms (2)

CDED diet

EXPERIMENTAL

The CDED will be divided into 3 stages: 0-6 weeks- induction phase (phase 1), weeks 7-12 step-down phase (phase 2), week 13 -24 maintenance phase (phase 3). During these weeks the diet is structured and contains a list of allowed/disallowed foods, and mandatory foods with specific daily/weekly amounts. Patients will be asked to progress with the diet if they respond to the diet clinically. Patients who do not improve, but show a clinicaly significant trend in symptoms, may be asked to prolong a dietary phase until reaching clinical reaction.

Other: CDED diet

standard diet

NO INTERVENTION

The control standard diet will be personally tailored for nutritional needs according to patient's daily recommended intake (DRI) for calories and protein intake (25kcal/kg and 0.8-1gr/kg per day respectivlly), and will follow the clinical guidelines for dietary therapy of patients with IBD.

Interventions

CDED diet OTHER

examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in adults suffering from active pouchitis.

CDED diet

Eligibility Criteria

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

You may qualify if:

• 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:
• 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\*.
• Informed consent and ability to complete the study protocol.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Pouchitis

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Central Study Contacts

Nitsan Maharshak, Dr.

CONTACT

+972527360384; nitsanm@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 1. Twenty patients, at 0-3 months post ileostomy closure will be enrolled for the study. Patients will be randomized to receive the CDED or standard diet at a ratio of 1:1 2. Fourty two adults with a diagnosis of acute exacerbation of pouchitis will be included in the study. Participants will be randomised to receive the CDED or standard diet at a ratio of 1:1. Upon initiation of the patient recruitment, 15 pouchitis patients will be treated with the study diet (modified CDED) for 24 weeks per treatment protocol as a pilot study.

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

IL (1)