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Completed

NCT Number: NCT00694564

Evaluation 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.

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Key information

Age range

8 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-adenosyl methionine

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Safety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Huang, Jeannie, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Jun 10, 2008
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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