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

NCT00694564 | Completed Results DMC

• 2 other identifiers: UCSD060705IND 75,404
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Keywords

abdominal pain; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety

  0, 2 weeks, 1 month, 2 month

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: S-adenosyl methionine

Interventions

S-adenosyl methionine DRUG

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

Also known as: SAM-e, Mood Plus

Treatment

Eligibility Criteria

• Age: 8 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Huang, Jeannie, M.D.: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Jeannie Huang
• Organization: UC San Diego

jshuang@ucsd.edu

858-576-1700

Study Officials

• Jeannie Huang, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: June 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2012
• Last Updated: March 16, 2018
• Results First Posted: September 13, 2013

Record last verified: 2016-01

Locations

US (1)