Diet in Pediatric Crohn´s Disease Treated With Biologics
Study Details
Study Description
Brief Summary
Cded in remission patients with high calprotectin
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diet 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. |
Dietary Supplement: Crohn's disease exclusion diet
Patients will receive, in addition to their normal treatment, polymeric formula + diet
|
| No Intervention: Control Patients with normal treatment( biologic treatment indicated for CD) |
Outcome Measures
Primary Outcome Measures
- Number of Participants with calprotectin less than 250 at week 12 [week 12]
Number of participants who achieve normal fecal calprotectin after the diet
- Level of calprotectin [week 12]
To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.
Secondary Outcome Measures
- Adherence [12 weeks]
Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients under 18 years of age
-
With a diagnosis of CD
-
Who have completed remission induction with biologic therapy
-
Who are on maintenance biologic therapy
-
Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).
Exclusion Criteria:
-
Children who are unable to receive enteral dietary intake
-
Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development
-
Children already on special diets
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | 1199 |
Sponsors and Collaborators
- Hospital Italiano de Buenos Aires
Investigators
- Principal Investigator: Marina Orsi, M.D., Hospital Italiano
Study Documents (Full-Text)
More Information
Publications
None provided.- 5992