CompletedNot Applicable

The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

United States33 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

3 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Induction of phase III of the migrating motor complex

Timeframe: 30 minutes after study drug administration

Trial details

NCT IDNCT01530009

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials