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
Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background.
One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet.
Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive Enteral Nutrition | Experimental | 35kcal/kg/day EEN (Nestle Modulen®) - Subjects will take medicine and EEN solution orally themselves. |
|
| Standard of care | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEN (Nestle Modulen®) | Dietary Supplement | 35kcal/kg/day for every patient |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with mucosal healing | Defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤2, at 12 weeks after randomization. The ileocolonoscopies will be evaluated by the site. SES-CD is an index for determining the severity of Crohn's disease. The SES-CD considers size of ulcerations, ulcerated surface, effected surface and the presence of narrowings, evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 60 where higher scores indicate more severe endoscopic activity. | 12 weeks |
| Percentage of patients that tolerate the EEN by week 12 | Defined as withdrawal from the study from randomization through 12 weeks after randomization | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic response | Defined as decrease in SES-CD > 50% from baseline at 12 weeks after randomization | 12 weeks |
| Mean change from baseline in SES-CD at 12 weeks after randomization | Mean change from baseline in SES-CD |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salih Tokmak | Contact | 0905052532698 | salihtokmak@duzce.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Salih Tokmak | Duzce University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duzce University School of Medicine | Recruiting | Düzce | 81620 | Turkey (Türkiye) |
Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR) will be shared
After publication, for a year
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
| ID | Term |
|---|---|
| D019819 | Budesonide |
| D011239 | Prednisolone |
| D008775 | Methylprednisolone |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
This is an open-label, randomized, multicenter, interventional, parallel-group study, designed to evaluate the efficacy and tolerability of EEN in inducing clinical remission at 12 weeks in subjects with ileocaecal CD.
Patients will receive EEN for 8 weeks, initially building up to the full required volume of formula over the first 3 to 4 days, depending on tolerance and side effects After the completion of the period of EEN, foods will be reintroduced slowly and supplementary enteral nutrition will be continued for another 4 weeks.
A total of 256 patients with ileocaecal CD will be randomized in a 1:1 ratio to receive steroids and EEN. Each of the treatment arms will comprise 128 subjects. In order to make the groups comparable, randomization will be stratified according to the severity of the disease according to Crohn's Disease Activity Index (CDAI):
Not provided
Not provided
Not provided
Not provided
| Standart of care |
| Drug |
|
|
|
| 12 weeks |
| Mean change from baseline in CDAI over time (Time Frame: Baseline, 4, 8 and 12 weeks after randomization) | The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from baseline indicates improvement. | 12 weeks |
| Time to clinical remission (Time frame: from randomization through 12 weeks after randomization) | Clinical remission was defined as:
Two-item Patient Reported Outcome (PRO-2) is a health outcome directly reported by the patient to quantify a treatment's efficacy that is derived from CDAI diary card. Participants were asked to record daily number of liquid or very soft stools and the severity of abdominal pain (defined as; 0=none, 1=mild, 2=moderate 3=severe). PRO-2 is the sum of the products of each item multiplied by a weighing factor. PRO-2 scores that correspond to CDAI thresholds are: Mild Moderate Severe CDAI 150 220 450 PRO-2 8 14 34 | 12 weeks |
| Time to clinical response (Time frame: from randomization through 12 weeks after randomization) | Clinical response was defined as:
| 12 weeks |
| Mean change from baseline in C-reactive protein (CRP) over time (Time Frame: 4, 8 and 12 weeks after randomization) | Changes in CRP levels | 12 weeks |
| Mean change from baseline in fecal calprotectin (FC) over time (Time Frame: 4, 8 and 12 weeks after randomization) | Changes in fecal calprotectin levels | 12 weeks |
| Mean change from baseline in PRO-2 (Time Frame: Baseline and 12 weeks after randomization) | Two-item Patient Reported Outcome (PRO-2) is a health outcome directly reported by the patient to quantify a treatment's efficacy that is derived from CDAI diary card. Participants were asked to record daily number of liquid or very soft stools and the severtiy of abdominal pain (defined as; 0=none, 1=mild, 2=moderate 3=severe). PRO-2 is the sum of the products of each item multiplied by a weighing factor. PRO-2 scores that correspond to CDAI thresholds are: Mild Moderate Severe CDAI 150 220 450 PRO-2 8 14 34 | 12 weeks |
| Change from baseline in SIBDQ total score (Time Frame: Baseline and 12 weeks after randomization) | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item HrQOL questionnaire designed to quantify the changes in patients' daily activity, related to Crohn's disease symptoms. Participants were asked questions about physical, social, emotional, and systemic aspects and scored on a 7-point scale from 1 (severe problem) to 7 (no problems at all). The score ranges from 1 to 70 where higher scores indicate better HrQOL. | 12 weeks |
| Change in Robarts Histopathology Index (RHI) (Time Frame: Baseline and 12 weeks after randomization) | RHI is a research tool used to quantify the histologic changes and to assess the degree of inflammation in the mucosa. RHI= 1xchronic inflammatory infiltrate level (4 levels)
The total score ranges from 0 (no disease activity) to 33 (severe disease activity). RHI≤3 corresponds to histologic remission. | 12 weeks |
| Number of Crohn's disease-related hospitalizations after randomization (Time Frame: From randomization through 12 weeks after randomization) | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department. | 12 weeks |
| D007410 | Intestinal Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |