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

Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02539849

Enrollment

Registered

2015-09-03

Start date

2014-12-31

Completion date

2017-12-19

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

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

Interventions

DIETARY_SUPPLEMENTFOS

DRUGAdalimumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026