Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FOS
Adalimumab
Sponsored by
About this trial
This is an interventional other trial for Crohn Disease
Eligibility 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.
Sites / Locations
- Hospital de Santiago
- Hospital de Bellvitge
- Hospital Universitari vall d'Hebron
- Hospital Josep Trueta
- Hospital La Princesa
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
adalimumab + FOS
Arm Description
Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)
Outcomes
Primary Outcome Measures
FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
Secondary Outcome Measures
Full Information
NCT ID
NCT02539849
First Posted
August 4, 2015
Last Updated
January 30, 2018
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT02539849
Brief Title
Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
Official Title
Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
December 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adalimumab + FOS
Arm Type
Other
Arm Description
Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)
Intervention Type
Dietary Supplement
Intervention Name(s)
FOS
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Primary Outcome Measure Information:
Title
FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de Bellvitge
City
Hospitalet del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
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