"Tasty&Healthy" Dietary Approach for Crohn's Disease

NCT04239248 | Completed

• 1 other identifier: Tasty&Healthy
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the advent of multiple novel medications, many patients with Crohn's disease (CD) fail to achieve mucosal healing (MH). Exclusive enteral nutrition (EEN) has been shown to induce clinical remission accompanied by MH in many of CD patients. The aim of this proposal is to explore the effectiveness of the "Tasty\&Healthy" dietary approach based on avoiding "pro-inflammatory" and processed ingredients, for inducing and maintaining remission and MH in children and young adults. This approach is based on the previously published charity cook-book "Tasty\&Healthy" and might be more feasible than currently available nutritional treatments in CD. It does not offer a rigid diet with specific nutrients and does not require concurrent use of a formula feed. The investigators hypothesize that a flexible dietary intervention of excluding processed and pro-inflammatory ingredients will improve the rate of clinical remission and MH without the need for liquid formula or structured rigid diet which are more difficult to adhere to. The investigators also hypothesize that home kits of Fecal calprotectin (FC), can personalize the diet thereby increasing feasibility for maintenance therapy in some patients.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• ACTIVE-RCT-I: patient's tolerance to the diet by week 8.

  Percent of patients tolerating the diet. Tolerance is defined as the absence of all of the three following items: 1. Intolerance: cessation of dietary therapy because of patient's refusal to continue diet (based on reporting and the 24 hour recall); 2. Poor adherence based on the modified Medication Adherence Report Scale (MARS) questionnaire; The modified MARS questionnaire rates How closely patients adhere to the diet. This is a self-report measure of adherence. It can be used to determine patients' willingness and ability to comply with the diet daily. A score of 1-5 indicates that the patient is not adherent; a score of 6-9 indicates that the patient is adherent. 3. Poor adherence based on direct questioning (any answer other than "adheres to diet very often/always" will be considered poor compliant).

  8 weeks

• MH-RCT-II: Rate of mucosal healing (MH).

  Percent of patients achieving MH defined by the proportion of patients with FC response as defined by reduction of at least 50% of FC levels from baseline; this has been added to the initial primary endpoint (i.e. MINI\<8 points) after enrolling five patients given new data that the MINI is less accurate in adults.

  8 weeks

Secondary Outcomes (3)

• Percent of patients achieving MH rate at Week 8 assessed with panenteric capsule endoscopy (i.e. Crohn's capsule) at the end of both trials as the major secondary outcome.

  8 weeks

• Percent of patients achieving clinical remission rate

  8 weeks

• Response rate defined as percent of patients achieving clinical remission and either reduction of FC levels.

  8 weeks

Study Arms (4)

ACTIVE-RCT-I Tasty&Healthy intervention group

EXPERIMENTAL

Patients with mild-moderately symptomatic disease, will follow the Tasty\&Healthy dietary approach.

Dietary Supplement: Tasty&Healthy intervention group

ACTIVE-RCT-I Control group

ACTIVE COMPARATOR

Patients with mild-moderately symptomatic disease, will receive EEN with Modulen formula only.

Dietary Supplement: EEN intervention group

MH-RCT-II Tasty&Healthy intervention group

EXPERIMENTAL

Patients with laboratory evidence of mucosal inflammation but who are asymptomatic or have only minimal symptoms not requiring immediate treatment modification, will follow the Tasty\&Healthy dietary approach.

Dietary Supplement: Tasty&Healthy intervention group

MH-RCT-II Control group

NO INTERVENTION

Patients with laboratory evidence of mucosal inflammation but who are asymptomatic or have only minimal symptoms not requiring immediate treatment modification, will continue their habitual diet.

Interventions

Tasty&Healthy intervention group DIETARY_SUPPLEMENT

patients will receive dietary advice to exclude pro-inflammatory dietary components based on the book "Tasty\&Healthy".

ACTIVE-RCT-I Tasty&Healthy intervention group; MH-RCT-II Tasty&Healthy intervention group

EEN intervention group DIETARY_SUPPLEMENT

Oral exclusive feeding of formulated food (EEN), using Modulen formula only, for 8 weeks in amount based on the Daily Recommendations Intake. Those not tolerating oral EEN can receive EEN via a nasogastric tube.

ACTIVE-RCT-I Control group

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ACTIVE-RCT-I
• Children and young adults aged 6-24 years with established diagnosis of CD by European crohn's and colitis organisation (ECCO) /The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.
• \<1 years of disease duration since the time of CD diagnosis.
• Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
• Mild- moderate disease activity (wPCDAI 20-57.5 or CDAI 200-45) or milder disease (wPCDAI 12.5-57.5 or CDAI 150-450) that according to the physician's discretion warrants an immediate change in treatment (and thus cannot be included in the MH-RCT-II that has a non-treatment arm).
• Currently receiving no drug treatment or on maintenance treatment with immunomodulators (at stable dose for at least 16 weeks) or 5-aminosalicylic acid (5ASA)/sulfasalazine (at stable dose for at least 8 weeks). No current or prior treatment with biologics is allowed (i.e. biologic-naïve).
• MH-RCT-II
• Children and young adults aged 6-40 years with established diagnosis of CD by ECCO/ESPGHAN criteria.
• \<1 years of disease duration since the time of CD diagnosis, or \<3 years of disease duration since the time of CD diagnosis for patients without evidence of significant bowel wall thickening (≤4 mm) without any damage as much as known.
• Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
• MINI ≥8 points.
• Clinical remission or at most minimal symptoms (wPCDAI\<20/ CDAI\<200) that according to the physician's discretion do not warrant immediate medical treatment.
• Receiving no treatment or on maintenance treatment with immunomodulators and/or first biologic (both at stable dose and interval for at least 16 weeks), and/or 5ASA/sulfasalazine (at stable dose for at least 8 weeks).
• Second line biologics are allowed for patients without evidence of significant bowel wall thickening (≤4 mm) without bowel damage as much as known.

You may not qualify if:

• Fibrostenotic or penetrating phenotype.
• Fistulizing perianal disease which is not in complete remission.
• "Ulcerative colitis (UC)-like" isolated Crohn's colitis.
• Prior failure of exclusive enteral nutrition or any other dietary intervention, for any reason.
• The use of steroids or budesonide in the recent month, or antibiotics prescribed to treat the CD in the previous two weeks.
• Any formula feed during the last month.
• Prior intestinal resection.
• Pregnancy.
• Celiac disease.
• For ACTIVE-RCT-I: any prior or concurrent biologic therapy; for MH-RCT-II: any prior or concurrent biologic therapy other than second line biologic

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

• Aharoni-Frutkoff Y, Plotkin L, Pollak D, Livovsky J, Focht G, Lev-Tzion R, Ledder O, Assa A, Yogev D, Orlanski-Meyer E, Broide E, Kierkus J, Kang B, Weiss B, Aloi M, Schwerd T, Shouval DS, Bramuzzo M, Griffiths AM, Yassour M, Turner D. Whole Food Diet Induces Remission in Children and Young Adults With Mild to Moderate Crohn's Disease and Is More Tolerable Than Exclusive Enteral Nutrition: A Randomized Controlled Trial. Gastroenterology. 2025 Dec;169(7):1462-1474.e2. doi: 10.1053/j.gastro.2025.06.011. Epub 2025 Jun 17.

  PMID: 40553742 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: January 27, 2020
• Study Start: April 1, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

IL (1)