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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00677378
First received: May 9, 2008
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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
Epigastric Pain
Retrosternal Pain
Esophagitis
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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 81
Study Start Date: December 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/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).

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

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
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.

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00677378

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

Publications:

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
Study First Received: May 9, 2008
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
TRPV1
Nerve growth factor
Capsaicin
TrkA
Retrosternal pain
Epigastric pain
Esophagitis
Gastrointestinal symptoms

Additional relevant MeSH terms:
Esophagitis
Chest Pain
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Esophageal Diseases
Digestive System Diseases
Gastroenteritis
Pain
Signs and Symptoms
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014