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

This study has been completed.
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin Identifier:
First received: May 9, 2008
Last updated: October 21, 2015
Last verified: October 2015
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

Epigastric Pain
Retrosternal Pain
Gastrointestinal Symptoms

Study Type: Observational
Study Design: 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

Further study details as provided by Manu Sood, Medical College of Wisconsin:

Primary Outcome Measures:
  • 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.

Enrollment: 77
Study Start Date: December 2006
Study Completion Date: October 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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).

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.

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
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Please refer to this study by its identifier: 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 Identifier: NCT00677378     History of Changes
Other Study ID Numbers: CHW 06/34
Study First Received: May 9, 2008
Last Updated: October 21, 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 processed this record on May 25, 2017