NCT04305535

Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease

Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 phase and to recover in the remission phase.

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 probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption

Conditions

• Crohn Disease
• Absorption; Disorder, Protein
• Absorption; Disorder
• Absorption; Disorder, Fat
• Absorption; Disorder, Carbohydrate
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Peptidic+Probiotic	Oligomeric oral nutritional supplement (Bi1 peptidic) and a mix of probiotics * Bifidobacterium animalis subsp. lactis BPL1, * Lactobacillus rhamnosus BPL15, * Lactobacillus rhamnosus CNCM i-4036 * Bifidobacterium longum ES1
DIETARY_SUPPLEMENT	Peptidic+Placebo	Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
DIETARY_SUPPLEMENT	Polymeric+Placebo	Polymeric oral nutritional supplement and a placebo

Timeline

• Start date: 2020-02-13
• Primary completion: 2021-02-01
• Completion: 2021-06-01
• First posted: 2020-03-12
• Last updated: 2020-03-12

Locations

1 site across 1 country: Spain