Status:
COMPLETED
Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Lead Sponsor:
Huang, Jeannie, M.D.
Conditions:
Abdominal Pain
Eligibility:
All Genders
8-22 years
Phase:
NA
Brief Summary
This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in children. This will be an open-labeled study and all participants will receive SAM-e therapy. G...
Eligibility Criteria
Inclusion
- 8 to 22 years old
- Diagnosed with RAP as verified by a physician, and having at least twice weekly episodes of abdominal pain which cause the patient to withdraw from normal activities.
- At least one month trial on a high fiber diet without resolution of abdominal pain.
- Ambulatory
Exclusion
- Focal abdominal pain by history or physical exam, unless a negative (including endoscopic) evaluation has been performed
- Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent), peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing gastrointestinal inflammation.
- Current or recent (within the past year) pregnancy and/or current breastfeeding.
- Current diagnosis of nephropathy or genitourinary disease.
- Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is not an exclusion criterion).
- Unintentional loss of over 10% body weight over the past 3 months or weight \< 100% ideal body weight.
- Recurrent fevers (T\>100F) at least once a week or with abdominal pain episodes.
- Recurrent dehydration with abdominal pain episodes requiring intravenous rehydration.
- Current personal diagnosis of depression or report of suicidality, mania or bipolar disorder.
- Family history of mania or bipolar disorder.
- Current use of opiates or other prescription pain medications and/or refusal to remain off opiate/prescription pain medications during the study period.
- Currently receiving additional therapies besides diet for recurrent abdominal pain and/or refusal to remain off such therapies during the study period, including but not limited to anticholinergic medications, antidepressant medications, biofeedback therapy, cognitive behavioral therapy.
- Hypersensitivity to SAM-e.
- Inability of child to provide assent and/or inability of parent/custodian to give consent.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00694564
Start Date
June 1 2007
End Date
July 1 2012
Last Update
March 16 2018
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92103