Status:
TERMINATED
Melatonin and Ulcerative Colitis: A Pilot Clinical Trial
Lead Sponsor:
Emory University
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and f...
Detailed Description
Problem of Interest: Current treatments for ulcerative colitis are not always effective, and often have serious side effects. Therefore, there is considerable interest in finding alternative treatmen...
Eligibility Criteria
Inclusion
- Age 18-69 years.
- Diagnosed with ulcerative colitis and currently experiencing a flare up of mild-moderate severity according to Mayo Scoring system (\>=4 and \<=10).
- Has a regular GI physician(s).
- Availability for 14 weeks after enrolling in the study.
- Female patients of child bearing potential must be surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (i.e., abstinence, oral, intramuscular, or implanted hormonal contraception, 2-barrier methods such as condom, diaphragm or spermicide).
Exclusion
- Night shift workers; otherwise, inability to attend morning study visits.
- Current severe colitis according to the Mayo Scoring System (\>10) or requiring hospital admission, or current very mild colitis (\<4).
- Current supplemental intake of melatonin or currently using tobacco products.
- Proctitis or Crohn's disease
- Previous gastrectomy or small or large bowel resection
- Malabsorption syndrome (e.g., pancreatic insufficiency).
- History of large bowel resection for any reason.
- Diagnosed narcotic or alcohol dependence.
- On renal dialysis.
- Active liver disease (a chronic condition or under current therapy)
- Seizure disorders
- Immune system disorders
- Any history of hypo- or hyperparathyroidism.
- Unable to be off aspirin for 7 days.
- Use of systemic or rectal steroids in the past 8 weeks.
- Have a history of allergy or hypersensitivity to melatonin.
- History of bleeding disorder or current use of anticoagulant medication.
- Current use of calcium channel blockers, anticonvulsants, sedatives, hypnotics, or psychotropic medications.
- Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the following 6 months, or are currently taking hormone replacement therapy (HRT).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00790478
Start Date
January 1 2009
End Date
April 1 2010
Last Update
February 12 2021
Active Locations (2)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Consultative Gastroenterology
Atlanta, Georgia, United States