Clinical Trial: Baclofen for Rumination

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome

Brief Summary: Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. Patients are asked to fill out questionnaires during the entire study period.

Detailed Summary:
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire. [ Time Frame: 2 weeks treatment ]

patients fill out questionnaires concerning overall wellbeing, during the 2 weeks of treatment. Results of these questionnaires will be compared between both conditions (baclofen and placebo).


Original Primary Outcome: Same as current

Current Secondary Outcome: objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring [ Time Frame: 2 weeks treatment ]

High Resolution impedance Manometry monitoring will be performed, with a meal. We will look at the number of times patients push an event marker, the number of time patients ruminate or have supra-gastric belching or have reflux episodes, or have transient lower esophageal sphincter relaxations, both before and after the meal. And we will compare these outcomes between placebo and baclofen.


Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: March 21, 2017
Date Started: February 1, 2012
Date Completion:
Last Updated: April 8, 2017
Last Verified: April 2017