Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Pathmakanthan

ORCID ID

Contact details

GI Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265122366

Study information

Scientific title

A double blind, randomised, placebo controlled trial investigating the efficacy and role of Synbiotic Cocktail 2000 in the treatment of Clostridium difficile diarrhoea and colitis

Acronym

Study hypothesis

1. To assess the role of Synbiotic Cocktail 2000 on symptom duration and relapse rates in patients with one or more episodes of C. difficile diarrhoea
2. To confirm the safety, tolerance and efficacy of Synbiotic Cocktail 2000 used with metronidazole for treatment of C. difficile diarrhoea and colitis compared with metronidazole and placebo
3. To assess the rate of C. difficile toxin and C. difficile elimination with Synbiotic Cocktail 2000 when compared to placebo
4. To investigate the ability of Synbiotic Cocktail 2000 to inhibit C. difficile and Toxin A production in vitro
5. To investigate the efficacy and duration of human gut colonisation by Synbiotic Cocktail 2000 during and after treatment
6. To investigate and characterise mucosa-associated bacteria in patients with antibiotic associated colitis before and after treatment with Synbiotic Cocktail 2000

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Clostridium difficile diarrhoea and colitis

Intervention

Treatment will be initiated at the time of acute relapse and patients will commence on oral metronidazole with either probiotic or placebo. Antibiotic therapy will be continued for seven days while probiotic or placebo will continue for three weeks. Any relapse in symptoms will require oral vancomycin. Stool samples will be obtained daily during initial metronidazole therapy until two stool samples are negative for C. difficile toxin. Daily stool diaries will be kept by all patients. At the end of the three week period of probiotic therapy, patients will undergo a rigid sigmoidoscopy examination and one rectosigmoid biopsy obtained for culture.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Disease relapse over one month

Secondary outcome measures

1. Disease relapse over three months
2. Rate of loss of C. difficile and toxin from the stool
3. Time to resolution of diarrhoea

Overall trial start date

16/01/2003

Overall trial end date

16/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient with a stool sample positive for Toxin A and clinically symptomatic in the Trust will be offered entry into the trial.

ASSESSMENT ON ADMISSION INTO TRIAL:
1. History and physical examination
2. Blood tests
3. Stool analysis for C. difficile and Toxin A
4. Rigid or flexible sigmoidoscopy with biopsies

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Patients may be removed from the study if one or more of the following occurs:
1. Protocol violation or non-compliance on part of the patient
2. Refusal of the patient to continue treatment and a decision by the investigator that termination is in the patient's best medical interest (or a significant unrelated medical illness or complication)

Recruitment start date

16/01/2003

Recruitment end date

16/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes