Clinical trial NCT00694564: 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
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Keywords: abdominal pain
children
Lead sponsor: Huang, Jeannie, M.D.
Sponsor class: INDIV
First posted: 2008-06-10
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: 0, 2 weeks, 1 month, 2 months
Secondary outcomes:
measure: Safety
timeFrame: 0, 2 weeks, 1 month, 2 month
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Jeannie Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: