The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children
Status:
Active, not recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable
effect on upper gastrointestinal motility compared to placebo. In particular, induction of
phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary
outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular
contractions that pass through the walls of the stomach and intestinal tract during the
fasting state. It is characterized by an initial period where there is a minimal electrical
activity and muscular contraction (phase I), followed by a gradual increase in the frequency
of contractions (phase III) that often leads to a characteristic cluster of contractions
(phase III). This cycle occurs only in the fasting state in normal individuals and the
frequency of phase III is quite varied, dependent on age and the presence of any underlying
abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics
of the MMC, patient demographics in responders and non-responders, and the safety profile of
AMX at the intervention dose.