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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	S-adenosyl methionine	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.

Primary Outcome Measures

Name	Time	Method
Wong-Baker FACES Pain Rating Scale	0, 2 weeks, 1 month, 2 months	We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).

Secondary Outcome Measures

Name	Time	Method
Safety	0, 2 weeks, 1 month, 2 month	Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.