Antibiotics for the Treatment of Ulcerative Colitis

NCT00355602 | Completed

• 1 other identifier: Tenovus 134/03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is unknown. However, it is widely accepted that bacteria living in the large bowel are essential for the development of the disease. Intuitively, therefore, a logical approach to treatment would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in managing acute colitis, and has had only limited benefit in long-term treatment. The failure of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria are involved in causing disease, and equally importantly, nobody has targeted appropriate antibiotics to knock out the specific bacteria in question, in a systematic way. Despite this, increasing evidence implicates bacteria living on the lining of the bowel being involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in the lower large intestine and to determine the antibiotic sensitivities of those the investigators believe to be particularly involved in the disease, such as enterococcit, peptostreptococci and enterobacteria. Because the investigators have already studied resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using a combination of two antibiotics in this work. A controlled trial will test the benefit of using these antibiotics over a period of one month and then the patients will be followed up over a six month period. The investigators will be looking for significant long-term improvements, and a reduction in drug use following antibiotic therapy.

Conditions

Colitis, Ulcerative

Keywords

Antibiotics; Controlled Clinical Trial

Outcome Measures

Primary Outcomes (1)

• sigmoidoscopy score 0,1 and 7 months

Secondary Outcomes (6)

• mucosal immune markers: human beta defensins, proinflammatory cytokines

• haemtaology indices

• biochemical indices

• clinical activity index

• bowel habit diary

Interventions

Cefuroxime DRUG

Ciprofloxacin DRUG

Clarithromycin DRUG

Cotrimoxazole DRUG

Coamoxiclav DRUG

metronidazole DRUG

neomycin DRUG

rifaximin DRUG

Vancomycin DRUG

Doxycycline DRUG

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active ulcerative colitis, CAI greater than or equal to 4

You may not qualify if:

• Antibiotics in the last 3 months
• Probiotics
• Alteration to medications in last 3 months

Sponsors & Collaborators

• University of Dundee: lead
• Tenovus Scotland: collaborator

Study Sites (1)

Ninewells Hospital and Medical School

Dundee, Angus, DD1 9SY, United Kingdom

Location

Related Publications (7)

• Montgomery SM, Morris DL, Thompson NP, Subhani J, Pounder RE, Wakefield AJ. Prevalence of inflammatory bowel disease in British 26 year olds: national longitudinal birth cohort. BMJ. 1998 Apr 4;316(7137):1058-9. doi: 10.1136/bmj.316.7137.1058. No abstract available.

  PMID: 9552907 BACKGROUND

• Mayberry JF, Ballantyne KC, Hardcastle JD, Mangham C, Pye G. Epidemiological study of asymptomatic inflammatory bowel disease: the identification of cases during a screening programme for colorectal cancer. Gut. 1989 Apr;30(4):481-3. doi: 10.1136/gut.30.4.481.

  PMID: 2785474 BACKGROUND

• Loftus EV Jr, Silverstein MD, Sandborn WJ, Tremaine WJ, Harmsen WS, Zinsmeister AR. Ulcerative colitis in Olmsted County, Minnesota, 1940-1993: incidence, prevalence, and survival. Gut. 2000 Mar;46(3):336-43. doi: 10.1136/gut.46.3.336.

  PMID: 10673294 BACKGROUND

• Cummings JH, Macfarlane GT, Macfarlane S. Intestinal bacteria and ulcerative colitis. Curr Issues Intest Microbiol. 2003 Mar;4(1):9-20.

  PMID: 12691258 BACKGROUND

• Onderdonk AB, Bartlett JG. Bacteriological studies of experimental ulcerative colitis. Am J Clin Nutr. 1979 Jan;32(1):258-65. doi: 10.1093/ajcn/32.1.258. No abstract available.

  PMID: 760501 BACKGROUND

• Macfarlane S, Furrie E, Cummings JH, Macfarlane GT. Chemotaxonomic analysis of bacterial populations colonizing the rectal mucosa in patients with ulcerative colitis. Clin Infect Dis. 2004 Jun 15;38(12):1690-9. doi: 10.1086/420823. Epub 2004 May 25.

  PMID: 15227614 BACKGROUND

• 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: 15647189 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Cefuroxime; Ciprofloxacin; Clarithromycin; Trimethoprim, Sulfamethoxazole Drug Combination; Amoxicillin-Potassium Clavulanate Combination; Metronidazole; Neomycin; Rifaximin; Vancomycin; Doxycycline

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Erythromycin; Macrolides; Polyketides; Lactones; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations; Clavulanic Acid; Clavulanic Acids; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Aminoglycosides; Glycosides; Carbohydrates; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons

Study Officials

• George T Macfarlane, BSCc, PHD

  University of Dundee

  PRINCIPAL INVESTIGATOR

• John H Cummings, MBChB MSc MA

  University of Dundee

  PRINCIPAL INVESTIGATOR

• Sandra Macfarlane, BSc, PhD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2006
• First Posted: July 24, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 11, 2009

Record last verified: 2009-02

Locations

GB (1)