Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/11/2011
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 Stephen Lewis

ORCID ID

Contact details

Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)7669 008 863

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093560 - PROJ 30/10/2000

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Dietary sulphate metabolism

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Senna, loperamide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/01/2001

Overall trial end date

10/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

12 volunteers

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/01/2001

Recruitment end date

10/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 201A
Cambridge
CB2 2QQ
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

Cambridge Consortium - Addenbrooke's (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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17156141

Publication citations

  1. Results

    Lewis S, Cochrane S, Alteration of sulfate and hydrogen metabolism in the human colon by changing intestinal transit rate., Am. J. Gastroenterol., 2007, 102, 3, 624-633, doi: 10.1111/j.1572-0241.2006.01020.x.

Additional files

Editorial Notes