Phase
Condition
Ulcerative Colitis (Pediatric)
Colic
Dysmenorrhea (Painful Periods)
Treatment
N/AClinical Study ID
Ages 8-22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
8 to 22 years old
Diagnosed with RAP as verified by a physician, and having at least twice weeklyepisodes 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
Exclusion Criteria:
Focal abdominal pain by history or physical exam, unless a negative (includingendoscopic) evaluation has been performed
Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent),peptic ulcer disease, gastrointestinal infection (unresolved), or ongoinggastrointestinal 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 isnot 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 bipolardisorder.
Family history of mania or bipolar disorder.
Current use of opiates or other prescription pain medications and/or refusal to remainoff opiate/prescription pain medications during the study period.
Currently receiving additional therapies besides diet for recurrent abdominal painand/or refusal to remain off such therapies during the study period, including but notlimited to anticholinergic medications, antidepressant medications, biofeedbacktherapy, cognitive behavioral therapy.
Hypersensitivity to SAM-e.
Inability of child to provide assent and/or inability of parent/custodian to giveconsent.
Study Design
Connect with a study center
University of California, San Diego
San Diego, California 92103
United StatesSite Not Available

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