Overview

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

Status:
Completed
Trial end date:
2017-12-19
Target enrollment:
0
Participant gender:
All
Summary
FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborator:
AbbVie
Treatments:
Adalimumab
Criteria
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.