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

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694564
• Other study ID #: UCSD060705
• Secondary ID: IND 75,404
• Status: Completed
• Phase: N/A
• First received: June 6, 2008
• Last updated: February 20, 2018
• Start date: June 2007
• Est. completion date: July 2012

Study information

• Verified date: January 2016
• Source: Huang, Jeannie, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Drug:
• S-adenosyl methionine
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Huang, Jeannie, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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