Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02201186
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Canadian Association of General Surgeons
Information provided by (Responsible Party):
Dr. Carl J Brown, St. Paul's Hospital, Canada

Brief Summary:
Patients with a bowel condition called ulcerative colitis have bowel surgery in which a portion of their bowel is removed and the reconnected at the small bowel to the anus. Sometimes, after the surgery, this connection part, the pouch, would be inflamed in a condition called Acute Pouchitis. Physicians usually treat them by prescribing antibiotics; however, some patients do not respond and need additional surgery. In this study, we will test an alternative treatment for this complication by performing manuka honey enemas twice a day for 30 days. This is a pilot study and ten patients will undergo enema treatment.

Condition or disease Intervention/treatment Phase
Pouchitis Other: Manuka honey enema Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have given written informed consent
  • have been diagnosed with ulcerative colitis
  • have had total colectomy and ileal pouch anal anastomosis before
  • have presented with signs and symptoms of pouchitis within the last two months of signing the informed consent
  • PDAI of greater than or equal to 7

Exclusion Criteria:

  • patients who are unable to perform enema by themselves
  • patients with an allergy to honey

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, British Columbia
Saint Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
Dr. Carl J Brown
Canadian Association of General Surgeons
Investigators
Layout table for investigator information
Principal Investigator: Carl Brown Saint Paul's Hospital

Publications:

Layout table for additonal information
Responsible Party: Dr. Carl J Brown, Head, Division of General Surgery, clinical assistant professor of surgery at University of British Columbia, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT02201186     History of Changes
Other Study ID Numbers: H13-02740
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Dr. Carl J Brown, St. Paul's Hospital, Canada:
honey enema for pouchitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases