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Coordination Versus Pressure in Oesophageal Peristalsis

This study has been completed.
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00482885
First received: June 1, 2007
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. This allows not only contractile pressure to be measured, but also the coordination (proximal-distal) of contractions and the development of effective intra-bolus pressure (the force that drives bolus movement).

The study hypothesis is that (1) there will be a progressive increase in peristaltic pressure and decrease in velocity as the subjects move from the upright, through the supine to the upside down position and (2) the increase in pressure will be most evident in the mid-oesophagus at the transition zone between the striated and the smooth muscle contractions.


Condition
Gastroesophageal Reflux

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Position on Oesophageal Peristalsis and LOS Pressures: a High Resolution Manometry Study

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Enrollment: 25
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy controls and patients presenting with symptoms of reflux and endoscopy negative dysphagia

Criteria

Inclusion criteria

Subjects to be included in the study are those:

  1. male or female
  2. at least 18 years of age
  3. have given informed consent for the HRM procedure

Exclusion Criteria

For normal controls:

  1. with symptoms or a history of oesophageal gastrointestinal disease
  2. with regular intake of medication. Occasional use of analgesic (e.g. aspirin) is allowed
  3. with any hematological abnormalities
  4. with any evidence of infectious disease
  5. who are pregnant or breast-feeding.
  6. with evidence or history of drug or alcohol abuse within the past two years
  7. with diabetes mellitis
  8. with mental impairment limiting the ability to comply with study requirements
  9. who are taking or planning to take other investigational drugs during the study
  10. with use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics).
  11. with use of PPIs and H2 blockers

For patients:

  1. with no oesophageal symptoms (e.g. referred for studies prior to bariatric surgery)
  2. with mental impairment limiting the ability to comply with study requirements
  3. who are taking or planning to take other investigational drugs during the study
  4. with use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482885

Locations
United Kingdom
Oesophageal Laboratory, GSTT
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Mark Fox, MD Honorary Consultant and Senior Lecturer
  More Information

No publications provided

Responsible Party: Dr Rami Sweis, St Thomas' Hospital
ClinicalTrials.gov Identifier: NCT00482885     History of Changes
Other Study ID Numbers: 07/Q0702/3
Study First Received: June 1, 2007
Last Updated: June 24, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Esophagus
Peristalsis
Contractile Pressure
Coordination of contraction
Bolus transport
Esophageal function

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014