THE PATHOPHYSIOLOGY OF NOCTURNAL REFLUX IN OBESE SUBJECTS

Withdrawn

• Conditions: nocturnal GERD; nocturnal heartburn; 10017977

• Registration Number: NL-OMON34444
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Man and woman > 18 years of age
- Proven nocturnal GERD (pH < 4 during > 3 % of supine position)
- Obese subjects: BMI > 30 kg/m2

Exclusion Criteria

- Pre-existent esophageal motility disorders
- Proven obstructive sleep apnea with CPAP therapy
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- nocturnal reflux pattern (supine reflux, number of reflux episodes, LES<br /><br>pressure)<br /><br>- LES pressure during reflux episodes<br /><br>- esophageal clearance</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Esophageal high resolution manometry<br /><br>- basal LES pressure<br /><br>- gastroesophageal pressure gradient<br /><br>- distal esophageal contractil integral (parameter which quantifies the<br /><br>esophageal contraction)<br /><br><br /><br>pH-impedance signals<br /><br>- percentage non-acid reflux<br /><br>- bolus transit time<br /><br>- Symptom Association Probability (SAP-score)</p><br>