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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

Conditions
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Abdominal Pain

Intervention / Treatment
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* Drug: S-adenosyl methionine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: S-adenosyl methionine<br>* S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.<br>* Other names: Mood Plus;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly. | 0, 2 weeks, 1 month, 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal pain, children