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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539849
• Other study ID #: ADA-FOS
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: January 30, 2018
• Start date: December 2014
• Est. completion date: December 19, 2017

Study information

• Verified date: January 2018
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• FOS

Drug:
• Adalimumab

Locations

Country	Name	City	State
Spain	Hospital Universitari vall d'Hebron	Barcelona
Spain	Hospital Josep Trueta	Girona
Spain	Hospital de Bellvitge	Hospitalet del Llobregat	Barcelona
Spain	Hospital La Princesa	Madrid
Spain	Hospital de Santiago	Santiago de Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	AbbVie

Country where clinical trial is conducted

Spain, 

Outcome

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