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

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ClinicalTrials.gov Identifier: NCT04327219
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Pouchitis Crhon's Disease Like of the Pouch Other: CDED diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  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.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet ("CDED") for Ileal Pouch Anal Anastomosis ("IPAA") Patients With Endoscopic Deterioration or Clinically Suspected Pouchitis
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: CDED diet
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
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.

No Intervention: standard diet
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.



Primary Outcome Measures :
  1. steroid free clinical remission [ Time Frame: week 6 ]
    defined as Clinical pouchitis disease activity index ("PDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) sub score<2 for pouchitis patients


Secondary Outcome Measures :
  1. Steroid free clinical remission [ Time Frame: week 12 ]
    defined as Clinical pouchitis disease activity index ("PDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) sub score<2

  2. Maintanence of clinical remission [ Time Frame: week 24 ]
    defined as Clinical pouchitis disease activity index ("PDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) sub score<2

  3. Clinical response [ Time Frame: week 6 ]
    reduction in Clinical pouchitis disease activity index ("PDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) >1

  4. Pouchitis remission [ Time Frame: week 12 ]
    defined as pouchitis disease activity index ("PDAI" ranges between 0-18 where highest is the worst and lowest is best clinically) <7 points

  5. Pouchitis remission [ Time Frame: week 24 ]
    defined as pouchitis disease activity index ("PDAI" ranges between 0-18 where highest is the worst and lowest is best clinically)<7 points

  6. Clinically significant change in mean CRP [ Time Frame: week 6 ]
    normalization of CRP or reduction in CRP of ≥100mg/dl

  7. Clinically significant change in mean CRP [ Time Frame: week 12 ]
    normalization of CRP or reduction in CRP of ≥100mg/dl

  8. Clinically significant change in mean CRP [ Time Frame: week 24 ]
    normalization of CRP or reduction in CRP of ≥100mg/dl

  9. Clinically significant change in mean fecal calprotectin [ Time Frame: week 6 ]
    normalization in calprotectin or reduction in calprotectin of ≥150mg/gr

  10. Clinically significant change in mean fecal calprotectin [ Time Frame: week 12 ]
    normalization in calprotectin or reduction in calprotectin of ≥150mg/gr

  11. Clinically significant change in mean fecal calprotectin [ Time Frame: week 24 ]
    normalization in calprotectin or reduction in calprotectin of ≥150mg/gr



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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, endoscopic PDAI>2 points 1.1.3 MR/CTEnterography with evidence of inflammation of the pouch 1.1.4 Fecal calprotectin>250 µg/gr
  2. Lack of obstructive symptomes for 8 weeks
  3. Stable medications and doses:

    3.1 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.

  4. Informed consent and ability to complete the study protocol.

Exclusion Criteria:

  1. Pregnancy
  2. Use of systemic steroids / Budesonide >6 mg at baseline.
  3. Currently active systemic diseases such as spondylo-arthropathies, collagen vascular disease, renal failure, hepatitis or heart disease
  4. Positive Stool culture, stool parasites or clostridium difficile toxin or alternative C- Difficile test.
  5. Evidence of bowel stricture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327219


Contacts
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Contact: Nitsan Maharshak, Dr. +972527360384 nitsanm@tlvmc.gov.il

Locations
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Israel
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Nitsan Maharshak, PhD    972-3-6947305    nitsanm@tlvmc.gov.il   
Principal Investigator: Nitsan Maharshak, MD         
Sub-Investigator: Naomi Fliss Isakov, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: Eli Sprecher, MD, PI, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04327219    
Other Study ID Numbers: TASMC-0637-19-CTIL
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center:
pouchitis
crohn's disease of the pouch
crohn's disease exclusion diet
CDED
ileal pouch anal anastomosis
IPAA
Additional relevant MeSH terms:
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Crohn Disease
Pouchitis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileitis
Enteritis
Ileal Diseases