Synbiotic Treatment in Crohn's Disease Patients

Crohn's Disease Clinical Trial

Official title:

Synbiotic Treatment in Crohn's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305409
• Other study ID #: CZB/4/335
• Secondary ID: RND ID: 2004GA07
• Status: Completed
• Phase: N/A
• First received: March 20, 2006
• Last updated: February 10, 2009
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Synbiotic (Synergy I / B.longum)

Locations

Country	Name	City	State
United Kingdom	Dundee University, Dept of Pathology and Neuroscience	Dundee	Angus
United Kingdom	Ninewells Hospital and Medical School	Dundee	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Bartosch S, Woodmansey EJ, Paterson JC, McMurdo ME, Macfarlane GT. Microbiological effects of consuming a synbiotic containing Bifidobacterium bifidum, Bifidobacterium lactis, and oligofructose in elderly persons, determined by real-time polymerase chain reaction and counting of viable bacteria. Clin Infect Dis. 2005 Jan 1;40(1):28-37. Epub 2004 Dec 6. — View Citation

Bassi A, Dodd S, Williamson P, Bodger K. Cost of illness of inflammatory bowel disease in the UK: a single centre retrospective study. Gut. 2004 Oct;53(10):1471-8. — View Citation

Caprilli R, Gassull MA, Escher JC, Moser G, Munkholm P, Forbes A, Hommes DW, Lochs H, Angelucci E, Cocco A, Vucelic B, Hildebrand H, Kolacek S, Riis L, Lukas M, de Franchis R, Hamilton M, Jantschek G, Michetti P, O'Morain C, Anwar MM, Freitas JL, Mouzas IA, Baert F, Mitchell R, Hawkey CJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: special situations. Gut. 2006 Mar;55 Suppl 1:i36-58. — View Citation

Fite A, Macfarlane GT, Cummings JH, Hopkins MJ, Kong SC, Furrie E, Macfarlane S. Identification and quantitation of mucosal and faecal desulfovibrios using real time polymerase chain reaction. Gut. 2004 Apr;53(4):523-9. — View Citation

Furrie E, Macfarlane S, Cummings JH, Macfarlane GT. Systemic antibodies towards mucosal bacteria in ulcerative colitis and Crohn's disease differentially activate the innate immune response. Gut. 2004 Jan;53(1):91-8. — View Citation

Furrie E, Macfarlane S, Kennedy A, Cummings JH, Walsh SV, O'neil DA, Macfarlane GT. Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: a randomised controlled pilot trial. Gut. 2005 Feb;54(2):242-9. — View Citation

Macfarlane GT, Cummings JH. Probiotics and prebiotics: can regulating the activities of intestinal bacteria benefit health? BMJ. 1999 Apr 10;318(7189):999-1003. Review. — View Citation

Stange EF, Travis SP, Vermeire S, Beglinger C, Kupcinkas L, Geboes K, Barakauskiene A, Villanacci V, Von Herbay A, Warren BF, Gasche C, Tilg H, Schreiber SW, Schölmerich J, Reinisch W; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. Gut. 2006 Mar;55 Suppl 1:i1-15. — View Citation

Travis SP, Stange EF, Lémann M, Oresland T, Chowers Y, Forbes A, D'Haens G, Kitis G, Cortot A, Prantera C, Marteau P, Colombel JF, Gionchetti P, Bouhnik Y, Tiret E, Kroesen J, Starlinger M, Mortensen NJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut. 2006 Mar;55 Suppl 1:i16-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in mucosal TNF-alpha
Secondary	Number of patients in remission as assessed by CDAI.
Secondary	Significant differences in mucosal regeneration between pre-synbiotic and post-synbiotic therapy groups and pre-control and post-control therapy groups.
Secondary	Differences in TNF-alpha, IL-18 and INF-gamma between the post-synbiotic and post-control groups.