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

April 24, 2017 updated by: Dr. Carl J Brown

To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis (Pilot Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pouchitis is the most common long-term complication of ileal pouch-anal anastomosis (IPAA) in ulcerative colitis (UC). Pouchitis is defined as a clinical syndrome of watery, frequent, at times bloody stool accompanied by urgency, incontinence, abdominal cramps, malaise, and fever. The PDAI (Pouchitis Disease Activity Index) provides a standardized definition of pouchitis based on clinical, endoscopic, and histological markers. Pouchitis is defined as a score ≥ 7 and remission as a score < 7. Recently, the modified Pouchitis Disease Activity Index has been used to omit biopsy and histology from the standard PDAI. Omission of endoscopic biopsy and histology from the PDAI simplifies pouchitis diagnostic criteria, reduces the cost of diagnosis, and avoids delay associated with determining histology score, while providing equivalent sensitivity and specificity. Patients with acute pouchitis are managed routinely by antibiotics such as Ciprofloxacin and Metronidazole. This treatment has some side effects, is expensive, and fails to respond in some patients. Some patients who are unresponsive to antibiotic therapy will need to have a pouchectomy and ileostomy done.

On the other hand, multiple studies have shown that honey, especially manuka honey has anti-inflammatory, anti-bacterial, wound healing, and anti-ulcerous effects. Phenolic compounds in honey, such as flavonoids, have been reported to exhibit a wide range of biological activities, including antibacterial, antiviral, anti-inflammatory, antioxidant, antitumor, anti-allergic, and vasodilatory actions. This honey can clear infection, remove malodour, reduce inflammation and pain, cause edema and exudation to subside, and increase the rate of healing by stimulation of angiogenesis, granulation and epithelialization.

Due to problems associated with antibiotic therapy, such as side effects, cost and failure of some patients to respond, we are looking to find an alternative method for treating acute pouchitis. This study is designed to determine the effect of manuka honey on symptoms, signs and pathology of acute pouchitis patients. We will select patients with any of the signs and symptoms of pouchitis, such as abdominal pain, fever, frequency or urgency of defecation. Proctoscopy will be done before and after honey enema and the modified PDAI scores will be determined. The manuka honey enema will be administered twice a day, for one month. Then, the modified PDAI scores before and after completion of honey enema treatment of these patients, will be compared.

We know that bacterial overgrowth, ischemia, faecal stasis, recurrence of ulcerative colitis in the pouch, or possibly a novel third form of inflammatory bowel disease, are possible etiologies of pouchitis. We also know that manuka honey has anti-inflammatory and anti-bacterial properties. Some studies demonstrate that honey is effective in the treatment of induced colitis in animal models. However, there is no current literature on the effect of honey on colitis or pouchitis in humans. Based on the aforementioned properties of honey, and considering the probable etiologies of pouchitis, we expect that these patients will respond to this method of treatment.

Some research has been done on the effect of honey in the treatment of colitis in animal models, but there have been no clinical studies that have assessed this treatment in pouchitis, or even colitis, in humans. Considering the etiologies of pouchitis, such as inflammation and bacterial overgrowth, and considering the main effects of honey, such as anti-bacterial and anti-inflammatory efficacy, honey enema may be useful in the treatment of pouchitis. Our study is trying to determine the effect of manuka honey enema in the treatment of acute pouchitis. We will try to determine whether the honey enema helps to decrease inflammation and infection in the pouch, and thereby provide us with a safe alternative method for the treatment of pouchitis.

In this pilot study, we will select patients who have any of the signs and symptoms of acute pouchitis, such as abdominal pain, fever, frequency, or urgency of defecation. Proctoscopy will be performed on these patients. Ten patients with modified PDAI score ≥ 7 will receive honey enemas twice a day for one month. We chose a twice daily enema regimen, because patients with inflammatory bowel disease usually receive their enemas twice a day. We expect one month to be enough time, because the duration of antibiotic therapy for patients with acute pouchitis is about one month. Then, the PDAI score of these patients, before and after honey enema will be compared.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Saint Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2 weeks after the 30-day treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
throughout the 30-day honey enema treatment and within two weeks of the treatment completion date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Carl J Brown

Collaborators

Canadian Association of General Surgeons

Investigators

  • Principal Investigator: Carl Brown, Saint Paul's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 19, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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