Clinical trial NCT00677378: Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain
Official title: Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epigastric Pain
Retrosternal Pain
Esophagitis
Gastrointestinal Symptoms
Keywords: TRPV1
Nerve growth factor
Capsaicin
TrkA
Retrosternal pain
Epigastric pain
Esophagitis
Gastrointestinal symptoms
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2008-05-14
Enrollment: 77
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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

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 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

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Manu Sood, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1001/archpedi.154.2.150.
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. doi: 10.1111/j.1572-0241.2002.05820.x.
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. doi: 10.1046/j.1365-2036.1997.00167.x.
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. doi: 10.1152/ajpgi.2001.281.5.G1196.
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. doi: 10.1016/0016-5085(95)90055-1.
citation: Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. doi: 10.1016/S0140-6736(00)02750-1. No abstract available.
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. doi: 10.1007/s00418-005-0025-9. Epub 2005 Jul 22.
citation: Cervero F, Laird JM. Understanding the signaling and transmission of visceral nociceptive events. J Neurobiol. 2004 Oct;61(1):45-54. doi: 10.1002/neu.20084.
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. doi: 10.1016/s0140-6736(00)04503-7.
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. doi: 10.1016/s0140-6736(03)12392-6.
citation: Lewin GR, Mendell LM. Nerve growth factor and nociception. Trends Neurosci. 1993 Sep;16(9):353-9. doi: 10.1016/0166-2236(93)90092-z.
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. doi: 10.1038/nm0696-703.
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. doi: 10.1016/s1359-6101(03)00047-9.
citation: 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. doi: 10.1016/s0140-6736(94)91316-1. No abstract available.
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. doi: 10.1007/s102860200016.
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. doi: 10.1097/00004583-199704000-00019.