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

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Crohn Disease; Absorption; Disorder; Absorption; Disorder, Protein; Absorption; Disorder, Fat; Absorption; Disorder, Carbohydrate
• Intervention / Treatment: Dietary supplement: Peptidic+Probiotic; Dietary supplement: Peptidic+Placebo; Dietary supplement: Polymeric+Placebo

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 Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Miguel Aganzo Yeves
    • Contact: Miguel A Aganzo-Yeves, RD; Phone Number: +34661774925; Email: miguel.aganzo@fjd.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: Peptidic+Placebo; Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months	Dietary supplement: Peptidic+Placebo; Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
Placebo Comparator: Polymeric+Placebo; Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months	Dietary supplement: Polymeric+Placebo; Polymeric oral nutritional supplement and a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malabsorption	Body Weight Change (kg)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the consistency of the stools according to Bristol scale.	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.	6 months
Fat malabsorption	Presence of fat in the stool	6 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Biopolis S.L.; Adventia Pharma
• Investigators: Principal Investigator: Miguel Aganzo-Yeves, RD, Hospital Universitario Fundacion Jimenez Diaz; Study Director: Clotilde Vázquez-Martínez, MD, Hospital Universitario Fundacion Jimenez Diaz

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Probiotics; Oral Nutritional Supplements; Oligomeric diet; Peptidic diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Disease; Crohn Disease; Malnutrition
• Other Study ID Numbers: EC032-19_FJD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No