Visceral (Hyper)Sensitivity Clinical Trial
Official title:
The Effects of Butyrate Enemas on Visceral Perception
| NCT number | NCT00726817 |
| Other study ID # | MEC 06-3-020 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | July 29, 2008 |
| Last updated | February 22, 2017 |
| Start date | December 2007 |
| Verified date | July 2008 |
| Source | Maastricht University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
During this double blind, placebo controlled, randomised cross over study, healthy volunteers received an enema once daily for one week containing either placebo (saline), 50mM butyrate or 100mM of butyrate. Before and directly after each test period a barostat protocol was performed to measure parameters for visceral perception.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - healthy Exclusion Criteria: - age, under 18 or over 65 - use of pre- or probiotics during study and 3 months previous to study - previous bowel complaints - gastrointestinal disease or abdominal surgery |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,