Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

Completed · Not applicable

Conditions studied: Abdominal Pain

In brief

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. 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.

Key facts

Study ID

NCT00694564

Run by

Huang, Jeannie, M.D.

People needed

8

Starts

2007-06-01

Expected to finish

2012-07-01

Last updated by the study team

2018-03-16

Who can join

Age: 8 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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