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CompletedNCT00677378TRPV1Updated Oct 22, 2015

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

An observational study in Epigastric Pain, Retrosternal Pain and Esophagitis, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-10-22.

Sponsored by Medical College of Wisconsin · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
77
Ages
5 Years to 17 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Epigastric Pain
  • Retrosternal Pain
  • Esophagitis
  • Gastrointestinal Symptoms

Keywords

  • TRPV1
  • Nerve growth factor
  • Capsaicin
  • TrkA
  • Retrosternal pain
  • Epigastric pain
  • Esophagitis
  • Gastrointestinal symptoms
03

In context

Esophagitis

324 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 77 is below the median of 100 across 93 observational studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 546 studies on the registry; 120 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 57 (77%) have results posted.

Browse Medical College of Wisconsin studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
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.

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
77 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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).

06

What researchers measure

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.

    Time frame: 5 years

07

Study locations

1 site
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

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. doi: 10.1001/archpedi.154.2.150. PubMed 10665601 ↗
  • 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. PubMed 12135011 ↗
  • 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. PubMed 9218069 ↗
  • 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. PubMed 11668028 ↗
  • 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. PubMed 7835571 ↗
  • Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. doi: 10.1016/S0140-6736(00)02750-1. No abstract available. PubMed 11030288 ↗
  • 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. PubMed 16041554 ↗
  • 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. PubMed 15362152 ↗
  • 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. PubMed 11343743 ↗
  • 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. PubMed 12573376 ↗
  • 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. PubMed 7694405 ↗
  • 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. PubMed 8640566 ↗
  • 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. PubMed 12948520 ↗
  • 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. PubMed 7912365 ↗
  • 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. PubMed 12102460 ↗
  • 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. PubMed 9100431 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006, a primary completion of Dec 2014 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2008
First posted
May 14, 2008
Start
Dec 2006
Primary completionActual
Dec 2014
CompletionActual
Oct 2015
Last update
Oct 22, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00677378
Lead sponsor
Medical College of Wisconsin
Responsible party
Manu Sood (Chief, Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
May 14, 2008
Start date
Dec 2006
Primary completion
Dec 2014
Completion
Oct 2015
Last update
Oct 22, 2015

Study contacts

Manu Sood, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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