Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTIVE-RCT-I Tasty&Healthy intervention group | Experimental | Patients with mild-moderately symptomatic disease, will follow the Tasty&Healthy dietary approach. |
|
| ACTIVE-RCT-I Control group | Active Comparator | Patients with mild-moderately symptomatic disease, will receive EEN with Modulen formula only. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasty&Healthy intervention group | Dietary Supplement | patients will receive dietary advice to exclude pro-inflammatory dietary components based on the book "Tasty&Healthy". |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
Not provided
Inclusion Criteria:
ACTIVE-RCT-I
MH-RCT-II
Second line biologics are allowed for patients without evidence of significant bowel wall thickening (≤4 mm) without bowel damage as much as known.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40553742 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 | 8 weeks |
| 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. | 8 weeks |
| D007410 | Intestinal Diseases |