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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huang, Jeannie, M.D.

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.