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

This study has been completed.
Information provided by (Responsible Party):
Huang, Jeannie, M.D. Identifier:
First received: June 6, 2008
Last updated: January 27, 2016
Last verified: January 2016
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.

Condition Intervention
Abdominal Pain
Drug: S-adenosyl methionine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

Resource links provided by NLM:

Further study details as provided by Huang, Jeannie, M.D.:

Primary Outcome Measures:
  • Wong-Baker FACES Pain Rating Scale [ Time Frame: 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:
  • Safety [ Time Frame: 0, 2 weeks, 1 month, 2 month ]

Enrollment: 8
Study Start Date: June 2007
Study Completion Date: July 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00694564

United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Huang, Jeannie, M.D.
Principal Investigator: Jeannie Huang, MD, MPH University of California, San Diego
  More Information

Responsible Party: Huang, Jeannie, M.D. Identifier: NCT00694564     History of Changes
Other Study ID Numbers: UCSD060705
IND 75,404
Study First Received: June 6, 2008
Results First Received: March 20, 2013
Last Updated: January 27, 2016

Keywords provided by Huang, Jeannie, M.D.:
abdominal pain

Additional relevant MeSH terms:
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on May 23, 2017