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

Huang, Jeannie, M.D.

Status: Completed

Conditions: Abdominal Pain

Treatments: Drug: S-adenosyl methionine

Study type: Interventional

Identifiers

NCT00694564

IND 75,404

UCSD060705

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 8 to 22 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Treatment

Experimental group

Description:

This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.

Treatment:

Drug: S-adenosyl methionine