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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04305535
• Other study ID #: EC032-19_FJD
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: Miguel A Aganzo-Yeves, RD
• Phone: +34661774925
• Email: miguel.aganzo[@]fjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: June 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• Peptidic+Placebo
Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
• Polymeric+Placebo
Polymeric oral nutritional supplement and a placebo

Locations

Country	Name	City	State
Spain	Miguel Aganzo Yeves	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Adventia Pharma, S.L., Biopolis S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malabsorption	Body Weight Change (kg)	6 months
Secondary	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
Secondary	Fat malabsorption	Presence of fat in the stool	6 months