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 : February 7, 2022
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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 |
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Pouchitis Crhon's Disease Like of the Pouch | Other: CDED diet | Not Applicable |

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

Arm | Intervention/treatment |
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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.
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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.
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- steroid free clinical remission [ Time Frame: week 6 ]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
- Steroid free clinical remission [ Time Frame: week 12 ]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
- Maintenance of clinical remission [ Time Frame: week 24 ]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
- clinical and endoscopic remission [ Time Frame: week 12 ]defined as modified pouchitis disease activity index ("mPDAI" ranges between 0-12 where highest is the worst and lowest is best clinically) sub score<5
- clinical and endoscopic remission [ Time Frame: week 24 ]defined as modified pouchitis disease activity index ("mPDAI" ranges between 0-12 where highest is the worst and lowest is best clinically) sub score<5
- Clinical response [ Time Frame: week 6 ]reduction in Clinical pouchitis disease activity index ("cPDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) ≥1
- Clinical response [ Time Frame: week 12 ]reduction in Clinical pouchitis disease activity index ("cPDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) ≥1
- 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
- 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
- Clinically significant change in mean CRP [ Time Frame: week 6 ]normalization (CRP ≤5mg/l) of CRP or reduction in CRP of ≥10 mg/l
- Clinically significant change in mean CRP [ Time Frame: week 12 ]normalization (CRP ≤5mg/l) of CRP or reduction in CRP of ≥10 mg/l
- Clinically significant change in mean CRP [ Time Frame: week 24 ]normalization (CRP ≤5mg/l) of CRP or reduction in CRP of ≥10 mg/l
- Clinically significant change in mean fecal calprotectin [ Time Frame: week 6 ]normalization (≤150 mg/g) in calprotectin or reduction in calprotectin of ≥150mg/gr
- Clinically significant change in mean fecal calprotectin [ Time Frame: week 12 ]normalization (≤150 mg/g) in calprotectin or reduction in calprotectin of ≥150mg/gr
- Clinically significant change in mean fecal calprotectin [ Time Frame: week 24 ]normalization (≤150 mg/g) 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 |
Inclusion Criteria:
- 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
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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.
- Informed consent and ability to complete the study protocol.
Exclusion Criteria:
- 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

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
Contact: Nitsan Maharshak, Dr. | +972527360384 | nitsanm@tlvmc.gov.il |
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 |
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: | February 7, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pouchitis crohn's disease of the pouch crohn's disease exclusion diet |
CDED ileal pouch anal anastomosis IPAA |
Crohn Disease Pouchitis Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Ileitis Enteritis Ileal Diseases |