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OpenTrials
Completed

NCT Number: NCT00305409

Synbiotic Treatment in Crohn's Disease Patients

The purpose of this study is to determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to reduce mucosal inflammation and induce remission.

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Key information

Conditions

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

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dundee University, Dept of Pathology and Neuroscience, Dundee, Angus, United Kingdom

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About this study

Crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. The Th1-mediated inflammatory response in Crohn's disease is characterised by increased IL-18 and INF-gamma and especially TNF-alpha, which are formed by lamina propria mononuclear cells. The aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic, that we have previously shown to down-regulate TNF-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in Crohn's disease patients with active disease, in a randomised controlled trial. Crohn's disease is associated with high mortality and incurs significant social, commercial and NHS costs. Many patients are refractile to standard treatments, which often have undesirable side effects. An inexpensive, effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Crohn's disease of large bowel (+/- small bowel disease)
  • 18-79 years old
  • stable doses of medications
  • CDAI >150, <450

Exclusion criteria

  • short gut syndrome
  • pregnancy
  • lactation
  • antibiotic therapy in last 3 months
  • probiotic therapy in last 1 month
  • <18, >79 years old
  • CDAI <150 or >450
  • indeterminate colitis, ulcerative colitis
  • alterations to medications in last 3 months

Treatment and study plan

Synbiotic (Synergy I / B.longum)

Drug

Primary outcomes

  1. Reduction in mucosal TNF-alpha

Secondary outcomes

  1. Number of patients in remission as assessed by CDAI.

  2. Significant differences in mucosal regeneration between pre-synbiotic and post-synbiotic therapy groups and pre-control and post-control therapy groups.

  3. Differences in TNF-alpha, IL-18 and INF-gamma between the post-synbiotic and post-control groups.

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2006
Registry last updated
Feb 11, 2009

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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