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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00694564
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : September 13, 2013
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Drug: S-adenosyl methionine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Study Start Date : June 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694564


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

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Responsible Party: Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier: NCT00694564    
Other Study ID Numbers: UCSD060705
IND 75,404
First Posted: June 10, 2008    Key Record Dates
Results First Posted: September 13, 2013
Last Update Posted: March 16, 2018
Last Verified: January 2016
Keywords provided by Huang, Jeannie, M.D.:
abdominal pain
children
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive