Back to results

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

Primary Purpose

Crohn Disease

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Tasty&Healthy intervention group

EEN intervention group

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

6 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 biologic is not allowed.

Exclusion Criteria:

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 one first biologic

Sites / Locations

Shaare Zedek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

ACTIVE-RCT-I Tasty&Healthy intervention group

ACTIVE-RCT-I Control group

MH-RCT-II Tasty&Healthy intervention group

MH-RCT-II Control group

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

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: Intolerance: cessation of dietary therapy because of patient's refusal to continue diet (based on reporting and the 24 hour recall); 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. Poor adherence based on direct questioning (any answer other than "adheres to diet very often/always" will be considered poor compliant).

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.

Secondary Outcome Measures

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.

Rate of MH defined by a central reading panel which will include leading irritable bowel disease (IBD) medical experts. This panel will determine the mucosal inflammation rate at week 8.

Percent of patients achieving clinical remission rate

Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) by<12.5 points or Crohn's Disease Activity Index (CDAI)<150

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

Clinical remission: wPCDAI by<12.5 points or CDAI<150, and either reduction of at least 50% of FC levels from baseline or FC levels<150 µgr/gr.

Full Information

NCT ID

NCT04239248

First Posted

November 27, 2019

Last Updated

October 17, 2022

Sponsor

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04239248

Brief Title

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

Official Title

"Tasty&Healthy" is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shaare Zedek Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

The investigators plan to conduct a set of three studies: Two randomized controlled trials (RCT) both including the Tasty&Healthy dietary intervention for 8 weeks in CD patients aged 6-24 years vs. 1) EEN in mild-moderate CD, and the other RCT in CD patients aged 6-40 years vs. 2) a control group continuing their habitual diet in those with mucosal inflammation despite stable medical treatment, but who are in clinical remission or have only minimal symptoms not requiring immediate treatment. As a third study, responders from both trials will be offered to participate in an open label extension personalized-diet study of further 16 weeks (total 24 weeks), in which gluten and dairy will be gradually re-introduced based on repeated monthly home assays of FC while otherwise following the Tasty&Healthy dietary intervention in a treat-to-target management approach. Patients will be evaluated at baseline, week 4 and week 8 with additional weekly phone visits to ensure adherence with the diets and address questions. The extension study will include two clinic visits at weeks 16 and 24 and a monthly call to ensure adherence. The investigators hope to establish a dietary-approach which is simpler to implement than current nutritional alternatives. It will enable high flexibility in the allowed foods and does not require liquid formula. In turn, this could position Tasty&Healthy, not merely for inducing remission, but also as a feasible maintenance strategy in selected patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ACTIVE-RCT-I Tasty&Healthy intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

ACTIVE-RCT-I Control group

Arm Type

Active Comparator

Arm Description

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

Arm Title

MH-RCT-II Tasty&Healthy intervention group

Arm Type

Experimental

Arm Description

Arm Title

MH-RCT-II Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Tasty&Healthy intervention group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

EEN intervention group

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

8 weeks

Title

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

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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.

Description

Rate of MH defined by a central reading panel which will include leading irritable bowel disease (IBD) medical experts. This panel will determine the mucosal inflammation rate at week 8.

Time Frame

8 weeks

Title

Percent of patients achieving clinical remission rate

Description

Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) by<12.5 points or Crohn's Disease Activity Index (CDAI)<150

Time Frame

8 weeks

Title

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

Description

Clinical remission: wPCDAI by<12.5 points or CDAI<150, and either reduction of at least 50% of FC levels from baseline or FC levels<150 µgr/gr.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 biologic is not allowed. Exclusion Criteria: 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 one first biologic

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gili Focht

Phone

+972 25645028

gilif@szmc.org.il

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gili Focht

Phone

+972 25645028

gilif@szmc.org.il

First Name & Middle Initial & Last Name & Degree

Dan Turner, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs