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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Unknown

Conditions: Malnutrition; Absorption; Disorder, Carbohydrate; Absorption; Disorder, Protein; Absorption; Disorder; Absorption; Disorder, Fat; Crohn Disease

Treatments: Dietary Supplement: Peptidic+Placebo; Dietary Supplement: Peptidic+Probiotic; Dietary Supplement: Polymeric+Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04305535

EC032-19_FJD

Details and patient eligibility

About

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.

Full 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

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 3 patient groups, including a placebo group

Peptidic+Probiotic

Active Comparator group

Description:

Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and mix of probiotics during 6 months

Treatment:

Dietary Supplement: Peptidic+Probiotic

Peptidic+Placebo

Active Comparator group

Description:

Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months

Treatment:

Dietary Supplement: Peptidic+Placebo

Polymeric+Placebo

Placebo Comparator group

Description:

Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months

Treatment:

Dietary Supplement: Polymeric+Placebo