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

Not Applicable

Completed

• Conditions: Abdominal Pain
• Interventions: Drug: S-adenosyl methionine

• Registration Number: NCT00694564
• Lead Sponsor: Huang, Jeannie, M.D.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2011-03
• Study Completion: 2012-07
• Results First Submitted: 2013-03-20
• Results First Submitted QC: 2013-08-28
• Results First Posted: 2013-09-13
• Status Verified: 2016-01
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-03-16

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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States