Baclofen for Rumination

Study Overview
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Brief Summary
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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.

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

Conditions
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Rumination, Supra-gastric Belching

Intervention / Treatment
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* Drug: Baclofen
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical suspicion of rumination syndrome and/or supra-gastric belching. Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. 18 to 75 years old. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. Exclusion Criteria: Systemic diseases, known to affect esophageal motility. Surgery in thorax or in the upper part of the abdomen. Treatment with baclofen prior to the start of the study. Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. Pregnancy or breast feeding. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-controlled depression is allowed). History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: baclofen<br>Patients will receive baclofen (10mg t.i.d) for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is placebo (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing. | Drug: Baclofen<br>* baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.<br>* Other names: Lioresal;|
| Placebo Comparator: placebo<br>Patients will receive placebo for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is baclofen (10mg t.i.d) (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing. | Drug: Placebo oral capsule<br>* placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire. | 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). | 2 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring | 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. | 2 weeks treatment |