Back to resultsDiet in Pediatric Crohn´s Disease Treated With Biologics
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Crohn's disease exclusion diet
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility 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
Sites / Locations
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diet
Control
Arm Description
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.
Patients with normal treatment( biologic treatment indicated for CD)
Outcomes
Primary Outcome Measures
Number of Participants with calprotectin less than 250 at week 12
Number of participants who achieve normal fecal calprotectin after the diet
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.
Secondary Outcome Measures
Adherence
Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.
Full Information
NCT ID
NCT05034458
First Posted
June 12, 2021
Last Updated
September 21, 2023
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT05034458
Brief Title
Diet in Pediatric Crohn´s Disease Treated With Biologics
Official Title
Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cded in remission patients with high calprotectin
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients with normal treatment( biologic treatment indicated for CD)
Intervention Type
Dietary Supplement
Intervention Name(s)
Crohn's disease exclusion diet
Intervention Description
Patients will receive, in addition to their normal treatment, polymeric formula + diet
Primary Outcome Measure Information:
Title
Number of Participants with calprotectin less than 250 at week 12
Description
Number of participants who achieve normal fecal calprotectin after the diet
Time Frame
week 12
Title
Level of calprotectin
Description
To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Adherence
Description
Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Orsi, M.D.
Organizational Affiliation
Hospital Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diet in Pediatric Crohn´s Disease Treated With Biologics
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