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Antibiotic

Amoxicillin for Functional Gastrointestinal Disorders

N/A
Waitlist Available
Led By Carlo Di Lorenzo, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children aged 3-21 years referred to the Motility Department at Nationwide Children's Hospital for antroduodenal manometry testing
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after study drug administration
Awards & highlights

Study Summary

This trial is testing whether the antibiotic amoxicillin can help to increase the activity of the digestive system in people who have had little or no activity. The primary outcome will be the effect of amoxicillin on the interdigestive migrating motor complex (MMC), which is a series of electrical and muscle contractions that occur in the stomach and intestines during fasting. The study will also look at other measures of digestive activity and the safety of amoxicillin.

Eligible Conditions
  • Functional Gastrointestinal Disorders

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after study drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Induction of phase III of the migrating motor complex
Secondary outcome measures
Adverse events after study drug administration
Characteristics of the induced phase III of the migrating motor complex
Patient demographics

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AmoxicillinActive Control1 Intervention
A liquid preparation of amoxicillin will be administered during the study through a nasoduodenal catheter after random patient assignment.
Group II: PlaceboPlacebo Group1 Intervention
A liquid placebo will be administered via a nasoduodenal catheter to patients based on random assignment.

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,473 Total Patients Enrolled
Carlo Di Lorenzo, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
22 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children
Carlo Di Lorenzo 2012. "The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01530009.
~2 spots leftby Apr 2025
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