The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection). This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Botulinum toxin type A 75U dissolved in 3mL physiological serum injection in the upper esophageal sphincter
Placebo: physiological serum 3mL injection in the upper esophageal sphincter
AZ Delta
Roeselare, Belgium
Response to Botox versus placebo, 12 weeks after treatment.
This questionnaire is a treatment effect measure specific for inability to belch, where the change in symptoms from baseline is assessed, on a scale from 0% to 100%. 100% means complete resolution of symptoms, 0% means no improvement.
Time frame: week 12
Response to botox versus placebo 48 weeks after treatment.
We will use the questionnaire of 'Difficulties with belching', and response is defined as at least a 50% improvement on question 6A 'To what extent have the symptoms of \'difficulty burping air\' been reduced after treatment?\'.
Time frame: 48 weeks
Safety: count of each type of (serious) adverse events in each group
Safety: assessed by the number and type of (serious) adverse events that occurred in each group by week 48
Time frame: 4 weeks
Safety on swallowing: with SSQ
assessed by the Sydney Swallow Questionnaire 1 week and 4 weeks after the procedure.
Time frame: 4 weeks
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