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

NCT00677378 | Completed

• 1 other identifier: CHW 06/34
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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

Conditions

Epigastric Pain; Retrosternal Pain; Esophagitis; Gastrointestinal Symptoms

Keywords

TRPV1; Nerve growth factor; Capsaicin; TrkA; Retrosternal pain; Epigastric pain; Esophagitis; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EXPERIMENTAL

Children undergoing an endoscopy for retrosternal chest pain, epigastric pain, regurgitation, heart burn or dyspepsia.

CONTROL

Children undergoing an endoscopy for reasons not stated in the experimental group condition (i.e. celiac disease, rectal bleeding, polyps, weight loss, malabsorption).

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (16)

• 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.

  PMID: 10665601 BACKGROUND

• 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.

  PMID: 12135011 BACKGROUND

• 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.

  PMID: 9218069 BACKGROUND

• 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.

  PMID: 11668028 BACKGROUND

• 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.

  PMID: 7835571 BACKGROUND

• Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. doi: 10.1016/S0140-6736(00)02750-1. No abstract available.

  PMID: 11030288 BACKGROUND

• 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.

  PMID: 16041554 BACKGROUND

• 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.

  PMID: 15362152 BACKGROUND

• 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.

  PMID: 11343743 BACKGROUND

• 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.

  PMID: 12573376 BACKGROUND

• 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.

  PMID: 7694405 BACKGROUND

• 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.

  PMID: 8640566 BACKGROUND

• 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.

  PMID: 12948520 BACKGROUND

• 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.

  PMID: 7912365 BACKGROUND

• 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.

  PMID: 12102460 BACKGROUND

• 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.

  PMID: 9100431 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Esophagitis; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Manu Sood, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Associate Professor

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 14, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

US (1)