Back to resultsEvaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
S-adenosyl methionine
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Pain focused on measuring abdominal pain, children
Eligibility 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.
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Safety
Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00694564
Brief Title
Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Official Title
A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huang, Jeannie, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
abdominal pain, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-adenosyl methionine
Other Intervention Name(s)
SAM-e, Mood Plus
Intervention Description
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Primary Outcome Measure Information:
Title
Wong-Baker FACES Pain Rating Scale
Description
We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).
Time Frame
0, 2 weeks, 1 month, 2 months
Secondary Outcome Measure Information:
Title
Safety
Description
Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.
Time Frame
0, 2 weeks, 1 month, 2 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie Huang, MD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
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