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

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ClinicalTrials.gov Identifier: NCT00677378
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : October 22, 2015
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Epigastric Pain Retrosternal Pain Esophagitis Gastrointestinal Symptoms

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.

Study Design

Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain
Study Start Date : December 2006
Primary Completion Date : December 2014
Study Completion Date : October 2015
Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
We are collecting a single mucosal biopsy during an endoscopy procedure.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677378

United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Principal Investigator: Manu Sood, MD Medical College of Wisconsin
More Information


Responsible Party: Manu Sood, Chief, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00677378     History of Changes
Other Study ID Numbers: CHW 06/34
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Manu Sood, Medical College of Wisconsin:
Nerve growth factor
Retrosternal pain
Epigastric pain
Gastrointestinal symptoms

Additional relevant MeSH terms:
Chest Pain
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs