N/A
N=8
Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Abdominal Pain
Bottom Line
View on ClinicalTrials.gov: NCT00694564 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Wong-Baker FACES Pain Rating Scale — 3; 3; 4; 4 units on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- S-adenosyl methionine (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Huang, Jeannie, M.D.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wong-Baker FACES Pain Rating Scale |
3; 3; 4; 4 | 0.004 sig |
| SECONDARY Safety |
— | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00694564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.