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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: October 1, 2014
Last verified: October 2014

May 9, 2008
October 1, 2014
December 2006
December 2014   (final data collection date for primary outcome measure)
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 ]
  • To characterize the TRPV1 expression in the esophageal mucosa of children with esophagitis and to correlate the TRPV1 expression with severity of mucosal inflammation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To characterize the TRPV1 expression in the esophageal mucosa of children with retrosternal pain without esophageal mucosal inflammation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To characterize TRPV1 expression in children with gastrointestinal symptoms such as diarrhea, vomiting, and slow weight gain of feeding problems without histological evidence of esophageal mucosal disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the correlation of TRPV1 and TrkA expression in esophageal mucosa. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00677378 on ClinicalTrials.gov Archive Site
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Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain
Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

Children undergoing an endoscopy procedure for gastrointestinal symptoms and chest pain or reasons other than those listed in the exclusion criteria.

  • Epigastric Pain
  • Retrosternal Pain
  • Esophagitis
  • Gastrointestinal Symptoms
Not Provided
  • 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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00677378
CHW 06/34
No
Manu Sood, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: Manu Sood, MD Medical College of Wisconsin
Medical College of Wisconsin
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP