Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain

Esophagitis Clinical Trial

— TRPV1  

Official title:

Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677378
• Other study ID #: CHW 06/34
• Status: Completed
• Phase: N/A
• First received: May 9, 2008
• Last updated: October 21, 2015
• Start date: December 2006
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain
• Epigastric Pain
• Esophagitis
• Gastrointestinal Diseases
• Gastrointestinal Symptoms
• Retrosternal Pain
• Signs and Symptoms, Digestive

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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

Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 years	No