Expired Study
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San Diego, California 92103


Purpose:

This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in a total of 30 children. This will be an open-labeled study and all participants will receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of depression and pain with minimal side effects as compared to other antidepressant therapy, we hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal pain.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT00694564


Primary Contact:

Principal Investigator
Jeannie Huang, MD, MPH
University of California, San Diego


Backup Contact:

N/A


Location Contact:

San Diego, California 92103
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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