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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Crohn Disease

Treatments: Drug: Adalimumab; Dietary Supplement: FOS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02539849

ADA-FOS

Details and patient eligibility

About

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

Full description

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

adalimumab + FOS

Other group

Description:

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

Treatment:

Dietary Supplement: FOS

Drug: Adalimumab