To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis
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|ClinicalTrials.gov Identifier: NCT02201186|
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pouchitis||Other: Manuka honey enema||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis (Pilot Study)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: manuka honey enema treatment
Study patients diagnosed with acute pouchitis after bowel surgery for ulcerative colitis will perform manuka honey enemas twice a day for 30 days.
Other: Manuka honey enema
Study patients diagnosed with acute pouchitis will perform manuka honey enemas twice a day for 30 days.
- PDAI score [ Time Frame: within 2 weeks after the 30-day treatment ]PDAI score is a criterion for defining pouchitis. A PDAI score will be calculated from a proctoscopy assessment before treatment. Within two weeks after the treatment, another proctoscopy will be performed to determine the post-treatment PDAI score to see if there is a decrease in PDAI score for the study patients.
- Composite complications [ Time Frame: throughout the 30-day honey enema treatment and within two weeks of the treatment completion date ]includes stool frequency (no different, 1-2 stools/day > postoperative usual, 3 or more stools/day > postoperative usual), rectal bleeding (none or rare or present daily), fecal urgency or abdominal cramps (none, occasional or usual), presence of fever (temperature >37.8° C), abdominal pain (no, occasional or usual) and readmission to hospital for any reason.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201186
|Canada, British Columbia|
|Saint Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Carl Brown||Saint Paul's Hospital|