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
1 other identifier
interventional
38
1 country
5
Brief Summary
FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2014
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2017
CompletedJanuary 31, 2018
January 1, 2018
3.1 years
August 4, 2015
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
14 weeks
Study Arms (1)
adalimumab + FOS
OTHERAdalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects consuming prebiotic supplements (inulin, FOS, galactooligosaccharides (GOS)) in their regular diet.
- Antibiotic use within the past 2 months
- Previous anti-TNF therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari Vall d'Hebron Research Institutelead
- AbbViecollaborator
Study Sites (5)
Hospital de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital de Bellvitge
Hospitalet Del Llobregat, Barcelona, 08907, Spain
Hospital Universitari vall d'Hebron
Barcelona, 08035, Spain
Hospital Josep Trueta
Girona, 17007, Spain
Hospital La Princesa
Madrid, 28006, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
September 3, 2015
Study Start
December 1, 2014
Primary Completion
December 19, 2017
Study Completion
December 19, 2017
Last Updated
January 31, 2018
Record last verified: 2018-01