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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-19

Brief Summary

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

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Detailed Description

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

Conditions

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Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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adalimumab + FOS

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

Group Type OTHER

FOS

Intervention Type DIETARY_SUPPLEMENT

Adalimumab

Intervention Type DRUG

Interventions

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FOS

Intervention Type DIETARY_SUPPLEMENT

Adalimumab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No