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Cded in remission patients with high calprotectin
Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet | Experimental | Patients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin. |
|
| Control | No Intervention | Patients with normal treatment( biologic treatment indicated for CD) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crohn's disease exclusion diet | Dietary Supplement | Patients will receive, in addition to their normal treatment, polymeric formula + diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with calprotectin less than 250 at week 12 | Number of participants who achieve normal fecal calprotectin after the diet | week 12 |
| Level of calprotectin | To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Orsi, M.D. | Hospital Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | 1199 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37610564 | Derived | Arcucci MS, Menendez L, Orsi M, Gallo J, Guzman L, Busoni V, Lifschitz C. Role of adjuvant Crohn's disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn's disease having biochemical activity: A randomized, pilot study. Indian J Gastroenterol. 2024 Feb;43(1):199-207. doi: 10.1007/s12664-023-01416-x. Epub 2023 Aug 23. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2021 | Aug 28, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2021 | Aug 28, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D007410 | Intestinal Diseases |