NCT00305409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

2.5 years

First QC Date

March 20, 2006

Last Update Submit

February 10, 2009

Conditions

Crohn's Disease

Keywords

Crohn'sTNF-alphaSynbioticProbiotic

Outcome Measures

Primary Outcomes (1)

  • Reduction in mucosal TNF-alpha

Secondary Outcomes (3)

  • Number of patients in remission as assessed by CDAI.

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

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

Interventions

Synbiotic (Synergy I / B.longum)DRUG

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dundee University, Dept of Pathology and Neuroscience

Dundee, Angus, DD1 9SY, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (9)

  • 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. doi: 10.1136/gut.2004.044834.

    PMID: 15647189BACKGROUND

  • 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. doi: 10.1136/gut.2003.031245.

    PMID: 15016746BACKGROUND

  • 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. doi: 10.1086/426027. Epub 2004 Dec 6.

    PMID: 15614689BACKGROUND

  • Macfarlane GT, Cummings JH. Probiotics and prebiotics: can regulating the activities of intestinal bacteria benefit health? BMJ. 1999 Apr 10;318(7189):999-1003. doi: 10.1136/bmj.318.7189.999. No abstract available.

    PMID: 10195977BACKGROUND

  • 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. doi: 10.1136/gut.2004.041616.

    PMID: 15361497BACKGROUND

  • 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, Scholmerich 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(Suppl 1):i1-15. doi: 10.1136/gut.2005.081950a. No abstract available.

    PMID: 16481628BACKGROUND

  • 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. doi: 10.1136/gut.53.1.91.

    PMID: 14684582BACKGROUND

  • 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(Suppl 1):i36-58. doi: 10.1136/gut.2005.081950c.

    PMID: 16481630BACKGROUND

  • Travis SP, Stange EF, Lemann 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(Suppl 1):i16-35. doi: 10.1136/gut.2005.081950b.

    PMID: 16481629BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • George MacFarlane, BSc PhD

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 21, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

GB(2)