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ISRCTN
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ISRCTN23167543
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ClinicalTrials.gov identifier
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Public title
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An investigation into the influence of intestinal transit rate on the metabolism of dietary sulphate
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0544093560 - PROJ 30/10/2000
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Study hypothesis
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Influence of intestinal transit on sulphate metabolism.
Hydrogen sulphide (H2S) can be toxic to the colon. The principle source of H2S in the colon is from the conversion of sulphate to sulfide by bacteria. Other sources of H2S production include the fermentation of proteins of animal and plant origin. The majority of dietary sulphate is absorbed in the small intestine with relatively small amounts entering the colon. Intestinal transit speed is known to influence the absorption and breakdown of many dietary substances. In particular intestinal transit speed alters the colonic bacterial flora and fermentation of food. The purpose of this study is to look at the influence of intestinal transit time on the metabolism of sulphate as no data exist. If transit is an influence in sulphate metabolism, then many of the findings linking high concentrations of faecal H2S to diseases such as ulcerative colitis could be explained. A brief clinical and drug history would be taken.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Dietary sulphate metabolism
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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10/01/2001
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Anticipated end date
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10/01/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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12 volunteers
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Interventions
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During the protocol volunteers will take (once a day) either:
1. Senna (a laxative)
2. Loperamide (slows down the colon)
3. Placebo tablet
Volunteers will be asked to take a special diet designed to be low in sulphate. Dr Lewis will be in close contact during the study period to answer any queries and ensure that the senna or loperamide are having the desired effect. In addition they will take tablets containing sulphate. Intestinal transit speed will be measured by two methods. Two stool samples will be collected and a urine sample. After completing the protocol volunteers will have a 2-week washout period repeating the protocol but taking a different transit altering tablet. The volunteers will complete all three protocols.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Consortium - Addenbrooke's (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17156141
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Contact name
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Dr
Stephen
Lewis
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Address
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Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)7669 008 863
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Email
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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15/11/2011
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Date ISRCTN assigned
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12/09/2003
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