Status:
UNKNOWN
Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborating Sponsors:
Adventia Pharma
Biopolis S.L.
Conditions:
Crohn Disease
Absorption; Disorder, Protein
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute ...
Detailed Description
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of ...
Eligibility Criteria
Inclusion
- Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food.
- Willing to comply with the prescribed diet follow-up for CD.
Exclusion
- Having received antibiotics in the previous 3 months
- Having undergone intestinal resection surgery≥70-75%
- Refuse to participate in the study
- Comorbidity that allows to suspect survival \<1 year
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04305535
Start Date
February 13 2020
End Date
June 1 2021
Last Update
March 12 2020
Active Locations (1)
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1
Miguel Aganzo Yeves
Madrid, Spain, 28040