An investigation into the influence of intestinal transit rate on the metabolism of dietary sulphate
| ISRCTN | ISRCTN23167543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23167543 |
| Secondary identifying numbers | N0544093560 - PROJ 30/10/2000 |
- 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
Scientific
Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)7669 008 863 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Senna, loperamide |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/01/2001 |
| Completion date | 10/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 12 volunteers |
| 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
- England
- United Kingdom
Study participating centre
Box No 201A
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
