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

Not Applicable

• Conditions: Absorption; Disorder, Carbohydrate; Crohn Disease; Absorption; Disorder, Protein; Absorption; Disorder; Malnutrition; Absorption; Disorder, Fat
• Interventions: Dietary Supplement: Peptidic+Placebo; Dietary Supplement: Peptidic+Probiotic; Dietary Supplement: Polymeric+Placebo

• Registration Number: NCT04305535
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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 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

Study Timeline

• Study Start: 2020-02-13
• Status Verified: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12
• Primary Completion: 2021-02
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peptidic+Placebo	Peptidic+Placebo	Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months
Peptidic+Probiotic	Peptidic+Probiotic	Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and mix of probiotics during 6 months
Polymeric+Placebo	Polymeric+Placebo	Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months

Primary Outcome Measures

Name	Time	Method
Malabsorption	6 months	Body Weight Change (kg)

Secondary Outcome Measures

Name	Time	Method
Changes in the consistency of the stools according to Bristol scale.	6 months	Bristol scale: type 1= separate hard lumps, type 2= sausage shaped but lumpy, type 3= like a sausage but with cracks on ots surface, type 4= like a sausage or sanake, smooth and soft, type 5= soft blobs with clear cut-edges, type 6= fluffy pieces with ragged edges, a mushy stool, type 7 = watery, no solid pieces.
Fat malabsorption	6 months	Presence of fat in the stool

Trial Locations

Locations (1)

Miguel Aganzo Yeves; 🇪🇸 Madrid, Spain