The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• Children aged 3-21 years referred to the Motility Department at Nationwide Children's Hospital for antroduodenal manometry testing

Exclusion Criteria:

• History of allergic reaction to amoxicillin, amoxicillin-clavulanate, or cephalosporins with a common-side chain (e.g. cefadroxil, cefprozil, cefatrizine)

• Therapy with a prokinetic within 3 days of the scheduled antroduodenal manometry

• Families who do not agree to participate