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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Drug: S-adenosyl methionine

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.; Other Names: SAM-e; Mood Plus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huang, Jeannie, M.D.
• Investigators: Principal Investigator: Jeannie Huang, MD, MPH, University of California, San Diego

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 10, 2008

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: children; abdominal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: UCSD060705; IND 75,404