Effect of Prebiotic FOS on Intestinal Abundance of Faecal... | NCT02539849

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

NCT02539849

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Completed

Last Update Posted

Jan 31, 2018Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Crohn Disease

Interventions

FOS
Adalimumab

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014Actual

Primary Completion Date

Dec 19, 2017Actual

Completion Date

Dec 19, 2017Actual

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 31, 2015

First Posted Date

Sep 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Jan 31, 2018Actual

Name	Class
AbbVie	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adalimumab + FOS	Other	Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)	Dietary Supplement: FOS Drug: Adalimumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FOS	Dietary Supplement		adalimumab + FOS
Adalimumab

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Santiago		Santiago de Compostela	A Coruña	15706	Spain
Hospital de Bellvitge

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided