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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04305535
Other study ID # EC032-19_FJD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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