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

NCT02201186 | Completed Phase 2

• 1 other identifier: H13-02740
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pouchitis

Keywords

honey enema for pouchitis

Outcome Measures

Primary Outcomes (1)

• PDAI score

  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 Outcomes (1)

• Composite complications

  throughout the 30-day honey enema treatment and within two weeks of the treatment completion date

Study Arms (1)

manuka honey enema treatment

EXPERIMENTAL

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

Interventions

Manuka honey enema OTHER

Study patients diagnosed with acute pouchitis will perform manuka honey enemas twice a day for 30 days.

manuka honey enema treatment

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Carl J Brown: lead
• Canadian Association of General Surgeons: collaborator

Study Sites (1)

Saint Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (9)

• Sandborn WJ, Tremaine WJ, Batts KP, Pemberton JH, Phillips SF. Pouchitis after ileal pouch-anal anastomosis: a Pouchitis Disease Activity Index. Mayo Clin Proc. 1994 May;69(5):409-15. doi: 10.1016/s0025-6196(12)61634-6.

  PMID: 8170189 BACKGROUND

• Shen B, Achkar JP, Connor JT, Ormsby AH, Remzi FH, Bevins CL, Brzezinski A, Bambrick ML, Fazio VW, Lashner BA. Modified pouchitis disease activity index: a simplified approach to the diagnosis of pouchitis. Dis Colon Rectum. 2003 Jun;46(6):748-53. doi: 10.1007/s10350-004-6652-8.

  PMID: 12794576 BACKGROUND

• Kafadar I, Moustafa F, Yalcin K, Klc BA. A rare adverse effect of metronidazole: nervous system symptoms. Pediatr Emerg Care. 2013 Jun;29(6):751-2. doi: 10.1097/PEC.0b013e318294f389.

  PMID: 23736071 BACKGROUND

• Makhdoom A, Khan MS, Lagahari MA, Rahopoto MQ, Tahir SM, Siddiqui KA. Management of diabetic foot by natural honey. J Ayub Med Coll Abbottabad. 2009 Jan-Mar;21(1):103-5.

  PMID: 20364754 BACKGROUND

• Kilicoglu B, Gencay C, Kismet K, Serin Kilicoglu S, Erguder I, Erel S, Sunay AE, Erdemli E, Durak I, Akkus MA. The ultrastructural research of liver in experimental obstructive jaundice and effect of honey. Am J Surg. 2008 Feb;195(2):249-56. doi: 10.1016/j.amjsurg.2007.04.011.

  PMID: 18083132 BACKGROUND

• Cernak M, Majtanova N, Cernak A, Majtan J. Honey prophylaxis reduces the risk of endophthalmitis during perioperative period of eye surgery. Phytother Res. 2012 Apr;26(4):613-6. doi: 10.1002/ptr.3606. Epub 2011 Oct 6.

  PMID: 22508360 BACKGROUND

• Hussein SZ, Mohd Yusoff K, Makpol S, Mohd Yusof YA. Gelam Honey Inhibits the Production of Proinflammatory, Mediators NO, PGE(2), TNF-alpha, and IL-6 in Carrageenan-Induced Acute Paw Edema in Rats. Evid Based Complement Alternat Med. 2012;2012:109636. doi: 10.1155/2012/109636. Epub 2012 Jul 1.

  PMID: 22919407 BACKGROUND

• Medhi B, Prakash A, Avti PK, Saikia UN, Pandhi P, Khanduja KL. Effect of Manuka honey and sulfasalazine in combination to promote antioxidant defense system in experimentally induced ulcerative colitis model in rats. Indian J Exp Biol. 2008 Aug;46(8):583-90.

  PMID: 18814487 BACKGROUND

• Viuda-Martos M, Ruiz-Navajas Y, Fernandez-Lopez J, Perez-Alvarez JA. Functional properties of honey, propolis, and royal jelly. J Food Sci. 2008 Nov;73(9):R117-24. doi: 10.1111/j.1750-3841.2008.00966.x.

  PMID: 19021816 BACKGROUND

MeSH Terms

Conditions

Pouchitis

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Officials

• Carl Brown

  Saint Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Division of General Surgery, clinical assistant professor of surgery at University of British Columbia

Study Record Dates

• First Submitted: July 19, 2014
• First Posted: July 25, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

CA (1)