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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02539849
• Date of registration: 04/08/2015
• Prospective Registration: No
• Primary sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Public title: Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
• Scientific title: Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
• Date of first enrolment: December 2014
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02539849
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Dietary Supplement: FOS

Drug: Adalimumab

Primary Outcome(s)

FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients [Time Frame: 14 weeks]

Secondary ID(s)

ADA-FOS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AbbVie