This is a randomized, double-blind, placebo-controlled, cross-over clinical trial of buspirone in patients with complaints of dysphagia due to poor esophageal motility. The goal of this clinical trial is to study the effect of buspirone on esophageal motility by performing high resolution impedance manometry (HRiM).
Esophageal motility disorders can be characterized by poor esophageal motility with impaired clearance of the esophagus. Examples are Ineffective Esophageal Motility (IEM, \>70% of the swallows are ineffective or ≥50% are failed) and Absent Contractility (100% failed peristalsis). Both might be the underlying cause for dysphagia. Several studies have shown that poor esophageal motility can be manipulated by pharmacological means. Buspirone, a 5-HT1A agonist, is able to significantly increase distal esophageal wave amplitude and duration in healthy volunteers, suggesting it may be effective in IEM. At the moment, findings in patients with IEM are not consistent and depend on the dose and treatment duration. This cross-over trial will examine the use of buspirone in patients with dysphagia, with the intent of using a higher dose. We will use impedance/manometry and pressure flow analysis to liquid, viscous and solid boluses to evaluate the symptomatic and manometric effect of buspirone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
4 weeks of treatment with buspirone
4 weeks of treatment with placebo
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGHRiM Manometric Features: DCI 5ml supine
Changes in distal contractile integral (DCI, in mmHg\*s\*cm) between buspirone and placebo. DCI is established on HRiM. As primary endpoint, we will focus on the values for DCI for the liquid bolus, 5 ml in supine position.
Time frame: During manometric assessment after 4 weeks of treatment
Bolus passage score
Patients will evaluate the perception of each swallow during the manometric assessment via the following Likert score: 1-Normal, 2-Slow passage of bolus, 3-Stepwise passage, 4-Partial Blockage, 5-Complete Blockage.
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: PCI
Pharyngeal Esophageal Contractile Integral (PCI es., mm.Hg.s.cm)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DCI
Distal Esophageal Contractile Integral (DCI, mmHg.s.cm)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: Largest Break Size
Largest Break Size (cm)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DL
Distal Latency (DL, s)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: IRP4s
Integrated Relaxation Pressure EGJ 4sec (IRP4s, mmHg)
Time frame: During manometric assessment after 4 weeks of treatment
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HRiM Manometric Features: PFI
Pressure Flow Index (PFI, -)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: IR
Impedance Ratio (IR, -)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DPA
Distension Pressure Accommodation Phase (DPA, mmHg)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DPE
Distension Pressure Emptying Phase (DPE, mmHg)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: RP
Distal Ramp Pressure (RP, mmHg/s)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: CSI
Contractile Segment Impedance (CSI, Ohm)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: BPT
Bolus Presence Time (BPT, s)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: BFT
Bolus Flow Time (BFT, s)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: EGJ Rest.P
EGJ Resting Pressure (EGJ Rest.P, mmHg)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: EGJCI
EGJ Contractile Integral (EGJCI, mmHg.cm)
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: LES-CD
Lower Esophageal Sphincter - Crural Diaphragm (LES-CD, mm)
Time frame: During manometric assessment after 4 weeks of treatment
Mayo Dysphagia Questionnaire
Symptom questionnaire
Time frame: At baseline and after 4 weeks of treatment
Overall Treatment Evaluation (OTE)
Symptoms questionnaire
Time frame: At baseline and after 4 weeks of treatment
Overall Symptom Severity (OSS)
Symptom questionnaire
Time frame: At baseline and after 4 weeks of treatment