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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

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

Intervention / Treatment
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* Dietary Supplement: Peptidic+Probiotic
* Dietary Supplement: Peptidic+Placebo
* Dietary Supplement: Polymeric+Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peptidic+Probiotic<br>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<br>* 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<br>|
| Active Comparator: Peptidic+Placebo<br>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<br>* Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo<br>|
| Placebo Comparator: Polymeric+Placebo<br>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<br>* Polymeric oral nutritional supplement and a placebo<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oligomeric diet, Peptidic diet, Probiotics, Oral Nutritional Supplements