Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain - Full Text View

Sponsored by:	Medical College of Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00677378

Purpose

We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression along with microscopic changes associated with heart burn and abdominal pain

Condition
Epigastric Pain Retrosternal Pain Esophagitis Gastrointestinal Symptoms

Drug Information available for: Nerve growth factor Tyrosine Capsaicin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Capsaicin-Sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

To characterize the TRPV1 expression in the esophageal mucosa of children with esophagitis and to correlate the TRPV1 expression with severity of mucosal inflammation and microscopic changes. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

We are collecting a single mucosal biopsy during an endoscopy procedure.

Estimated Enrollment:	81
Study Start Date:	April 2006
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
EXP Children undergoing an endoscopy for retrosternal chest pain, epigastric pain, regurgitation, heart burn or dyspepsia.
CON Children undergoing an endoscopy for reasons not stated in the experimental group condition (i.e. celiac disease, rectal bleeding, polyps, weight loss, malabsorption).

Detailed Description:

Approximately 5% of children between 10-17 years of age report symptoms of heart burn, epigastric pain or regurgitation. This study will evaluate the changes in nerve innervation and TRPV1 receptor expression in children having upper endoscopy for evaluation of heart burn and abdominal pain.

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children undergoing an endoscopy procedure for gastrointestinal symptoms and chest pain or reasons other than those listed in the exclusion criteria.

Criteria

Inclusion Criteria:

Retrosternal and/or epigastric pain and esophagitis
Retrosternal and/or epigastric pain but no macroscopic or microscopic esophagitis
Gastrointestinal symptoms such as diarrhea, regurgitation, rumination, vomiting, feeding aversion, non-organic failure to thrive, celiac disease with no macroscopic or microscopic esophageal inflammation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677378

Contacts

Contact: Manu Sood, MD	414-266-3690	msood@mcw.edu
Contact: Muhammad Altaf, MD	414-266-3690	maltaf@mcw.edu

Locations

United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Manu Sood, MD 414-266-3690 msood@mcw.edu
Contact: Muhammad Altaf, MD 414-266-3690 maltaf@mcw.edu
Sub-Investigator: Paula North, MD, PhD
Sub-Investigator: Muhammad Altaf, MD
Sub-Investigator: Colin Rudolph, MD, PhD
Sub-Investigator: Banani Banerjee, PhD
Sub-Investigator: Adrian Miranda, MD
Sub-Investigator: Jyoti Sengupta, PhD

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator:

Manu Sood, MD

Medical College of Wisconsin

More Information

Publications:

Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 2000 Feb;154(2):150-4.

El-Serag HB, Bailey NR, Gilger M, Rabeneck L. Endoscopic manifestations of gastroesophageal reflux disease in patients between 18 months and 25 years without neurological deficits. Am J Gastroenterol. 2002 Jul;97(7):1635-9.

Carlsson R, Galmiche JP, Dent J, Lundell L, Frison L. Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta-analysis of long-term omeprazole trials. Aliment Pharmacol Ther. 1997 Jun;11(3):473-82.

Sarkar S, Hobson AR, Furlong PL, Woolf CJ, Thompson DG, Aziz Q. Central neural mechanisms mediating human visceral hypersensitivity. Am J Physiol Gastrointest Liver Physiol. 2001 Nov;281(5):G1196-202.

Mehta AJ, De Caestecker JS, Camm AJ, Northfield TC. Sensitization to painful distention and abnormal sensory perception in the esophagus. Gastroenterology. 1995 Feb;108(2):311-9.

Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. No abstract available.

Faussone-Pellegrini MS, Taddei A, Bizzoco E, Lazzeri M, Vannucchi MG, Bechi P. Distribution of the vanilloid (capsaicin) receptor type 1 in the human stomach. Histochem Cell Biol. 2005 Jul;124(1):61-8. Epub 2005 Jul 22.

Cervero F, Laird JM. Understanding the signaling and transmission of visceral nociceptive events. J Neurobiol. 2004 Oct;61(1):45-54. Review.

Yiangou Y, Facer P, Dyer NH, Chan CL, Knowles C, Williams NS, Anand P. Vanilloid receptor 1 immunoreactivity in inflamed human bowel. Lancet. 2001 Apr 28;357(9265):1338-9.

Chan CL, Facer P, Davis JB, Smith GD, Egerton J, Bountra C, Williams NS, Anand P. Sensory fibres expressing capsaicin receptor TRPV1 in patients with rectal hypersensitivity and faecal urgency. Lancet. 2003 Feb 1;361(9355):385-91.

Lewin GR, Mendell LM. Nerve growth factor and nociception. Trends Neurosci. 1993 Sep;16(9):353-9. Review.

Anand P, Terenghi G, Warner G, Kopelman P, Williams-Chestnut RE, Sinicropi DV. The role of endogenous nerve growth factor in human diabetic neuropathy. Nat Med. 1996 Jun;2(6):703-7.

Micera A, Puxeddu I, Aloe L, Levi-Schaffer F. New insights on the involvement of Nerve Growth Factor in allergic inflammation and fibrosis. Cytokine Growth Factor Rev. 2003 Oct;14(5):369-74. Review.

Anand P, Pandya S, Ladiwala U, Singhal B, Sinicropi DV, Williams-Chestnut RE. Depletion of nerve growth factor in leprosy. Lancet. 1994 Jul 9;344(8915):129-30. No abstract available.

Indo Y. Genetics of congenital insensitivity to pain with anhidrosis (CIPA) or hereditary sensory and autonomic neuropathy type IV. Clinical, biological and molecular aspects of mutations in TRKA(NTRK1) gene encoding the receptor tyrosine kinase for nerve growth factor. Clin Auton Res. 2002 May;12 Suppl 1:I20-32. Review.

March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65.

Responsible Party:	Medical College of Wisconsin ( Manu Sood/Principal Investigator )
Study ID Numbers:	CHW 06/34
Study First Received:	May 9, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00677378
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

TRPV1
Nerve growth factor
Capsaicin
TrkA

Retrosternal pain
Epigastric pain
Esophagitis
Gastrointestinal symptoms

Study placed in the following topic categories:

Esophagitis
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Pain
Esophageal Diseases
Gastroenteritis
Capsaicin

ClinicalTrials.gov processed this record on January 14, 2009