An investigation into the influence of intestinal transit rate on the metabolism of dietary sulphate

ISRCTN	ISRCTN23167543
DOI	https://doi.org/10.1186/ISRCTN23167543
Protocol serial number	N0544093560 - PROJ 30/10/2000
Sponsor	Department of Health (UK)
Funder	Cambridge Consortium - Addenbrooke's (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 15/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Lewis
Scientific

Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)7669 008 863

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Senna, loperamide
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	10/01/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	12
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/01/2001
Date of final enrolment	10/01/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Box No 201A

Cambridge
CB2 2QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007		Yes	No