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

Last updated: February 20, 2018
Sponsor: Huang, Jeannie, M.D.
Overall Status: Completed

Phase

N/A

Condition

Ulcerative Colitis (Pediatric)

Colic

Dysmenorrhea (Painful Periods)

Treatment

N/A

Clinical Study ID

NCT00694564
UCSD060705
IND 75,404
  • Ages 8-22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 8 to 22 years old

  • Diagnosed with RAP as verified by a physician, and having at least twice weeklyepisodes 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

Exclusion Criteria:

  • Focal abdominal pain by history or physical exam, unless a negative (includingendoscopic) evaluation has been performed

  • Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent),peptic ulcer disease, gastrointestinal infection (unresolved), or ongoinggastrointestinal 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 isnot 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 bipolardisorder.

  • Family history of mania or bipolar disorder.

  • Current use of opiates or other prescription pain medications and/or refusal to remainoff opiate/prescription pain medications during the study period.

  • Currently receiving additional therapies besides diet for recurrent abdominal painand/or refusal to remain off such therapies during the study period, including but notlimited to anticholinergic medications, antidepressant medications, biofeedbacktherapy, cognitive behavioral therapy.

  • Hypersensitivity to SAM-e.

  • Inability of child to provide assent and/or inability of parent/custodian to giveconsent.

Study Design

Total Participants: 8
Study Start date:
June 01, 2007
Estimated Completion Date:
July 31, 2012

Connect with a study center

  • University of California, San Diego

    San Diego, California 92103
    United States

    Site Not Available

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