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Completed

NCT Number: NCT02539849

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

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Santiago, Santiago de Compostela, A Coruña, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FOS

Dietary Supplement

Adalimumab

Drug

Primary outcomes

  1. FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • AbbVie

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 3, 2015
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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