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Contact Information:

Dr S Pathmakanthan


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Be Part of Research - Trial Details - 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
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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

Not Recruiting

Open to: All Genders

Age: Not Specified

Birmingham

Medical Conditions

Clostridium difficile diarrhoea and colitis

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Not provided at time of registration

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

16 Jan 2003 16 Jan 2004

Interventional

Intervention Type : Other
Intervention Description : 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.




You can take part if:



You may not be able to take part if:


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 patient2. 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)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Selly Oak Hospital
    Birmingham
    B29 6JD

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Dr S Pathmakanthan



The study is sponsored by Department of Health (UK) and funded by University Hospital Birmingham NHS Trust (UK).



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Read full details for Trial ID: ISRCTN10171652
Last updated 17 April 2015

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