To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis
Condition: Pouchitis
MeSH terms: Pouchitis
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Manuka honey enema
Intervention type(s): Other
Intervention description(s): Study patients diagnosed with acute pouchitis will perform manuka honey enemas twice a day for 30 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: honey enema for pouchitis