PouchitisPhase 2NCT02201186
To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis
A Phase 2 study testing Manuka honey enema in people with Pouchitis, run by Dr. Carl J Brown at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Pouchitis
- What is being tested?
- Manuka honey enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients who are unable to perform enema by themselves
- patients with an allergy to honey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pouchitis
- Being tested
- Manuka honey enema
- Keywords
- honey enema for pouchitis
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka honey enemaOther
Study patients diagnosed with acute pouchitis will perform manuka honey enemas twice a day for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Manuka honey enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2 weeks after the 30-day treatment
Secondary outcomes (1)
Composite complications
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.
Measured: throughout the 30-day honey enema treatment and within two weeks of the treatment completion date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Carl J Brown
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of General Surgeons
- Responsible party
- Sponsor-investigator, Dr. Carl J Brown, St. Paul's Hospital, Canada
- Investigators
- Carl Brown, Principal investigator, Saint Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201186
- Sponsor's protocol ID
- H13-02740
- Status last verified
- Apr 2017
- First submitted
- 19 Jul 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8170189Shen 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.
PubMed 12794576Kafadar 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.
PubMed 23736071Makhdoom 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.
PubMed 20364754Kilicoglu 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.
PubMed 18083132Cernak 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.
PubMed 22508360Hussein 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.
PubMed 22919407Medhi 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.
PubMed 18814487Viuda-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.
PubMed 19021816
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis (Pilot Study)
- ClinicalTrials.gov ID
- NCT02201186
- Acronym / sponsor ID
- H13-02740
- Conditions
- Pouchitis
- Keywords
- honey enema for pouchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dr. Carl J BrownUniversity, hospital or other
- Collaborators
- Canadian Association of General Surgeons
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| manuka honey enema treatment | Experimental | Other: Manuka honey enemaStudy patients diagnosed with acute pouchitis after bowel surgery for ulcerative colitis will perform manuka honey enemas twice a day for 30 days. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- patients who are unable to perform enema by themselves
- patients with an allergy to honey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuka honey enemaStudy patients diagnosed with acute pouchitis will perform manuka honey enemas twice a day for 30 days. | Other | manuka honey enema treatment |
Primary outcome
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.
1 secondary outcome
Composite complications
Time frame: throughout the 30-day honey enema treatment and within two weeks of the treatment completion date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 8170189Sandborn 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.
- Background: PubMed 12794576Shen 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.
- Background: PubMed 23736071Kafadar 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.
- Background: PubMed 20364754Makhdoom 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.
- Background: PubMed 18083132Kilicoglu 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.
- Background: PubMed 22508360Cernak 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.
- Background: PubMed 22919407Hussein 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.
- Background: PubMed 18814487Medhi 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.
- Background: PubMed 19021816Viuda-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown principal investigator
Saint Paul's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Manuka honey enema in people with Pouchitis, run by Dr. Carl J Brown at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDAI score (time frame: within 2 weeks after the 30-day treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201186, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.