Diet in Pediatric Crohn´s Disease Treated With Biologics
Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
1 other identifier
interventional
30
1 country
1
Brief Summary
Cded in remission patients with high calprotectin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2021
CompletedFirst Submitted
Initial submission to the registry
June 12, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedSeptember 25, 2023
September 1, 2023
2 years
June 12, 2021
September 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Adherence
12 weeks
Study Arms (2)
Diet
EXPERIMENTALPatients 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 INTERVENTIONPatients with normal treatment( biologic treatment indicated for CD)
Interventions
Patients will receive, in addition to their normal treatment, polymeric formula + diet
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Italiano de Buenos Aires
Buenos Aires, 1199, Argentina
Related Publications (1)
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.
PMID: 37610564DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Orsi, M.D.
Hospital Italiano
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
June 12, 2021
First Posted
September 5, 2021
Study Start
May 14, 2021
Primary Completion
June 1, 2023
Study Completion
June 20, 2023
Last Updated
September 25, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share