Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Dietary Supplement: FOS; Drug: Adalimumab

• Registration Number: NCT02539849
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease

Detailed Description

To demonstrate that FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients between 18 and 65 years old
• Crohn's disease patients
• Inflammatory activity confirmed by imaging techniques (colonoscopy or magnetic resonance imaging (MRI))
• Refractory inflammatory luminal disease (with or without perianal involvement) at any level of the gastrointestinal tract requiring therapy with adalimumab,according to standard clinical practice.
• Stable maintenance of any other medication (corticosteroids and / or immunosuppressants and/or 5-aminosalicylic acid (5-ASA)) for the past 4 weeks
• Screening tests required for a safe administration of anti tumour necrosis factor (anti-TNF) antibodies will be performed according to standard clinical practice

Exclusion Criteria

• Subjects consuming prebiotic supplements (inulin, FOS, galactooligosaccharides (GOS)) in their regular diet.
• Antibiotic use within the past 2 months
• Previous anti-TNF therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adalimumab + FOS	FOS	Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)
adalimumab + FOS	Adalimumab	Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)

Primary Outcome Measures

Name	Time	Method
FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients	14 weeks

Trial Locations

Locations (5)

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital de Bellvitge; 🇪🇸 Hospitalet del Llobregat, Barcelona, Spain

Hospital de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Hospital Universitari vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Josep Trueta; 🇪🇸 Girona, Spain