The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

NCT01530009 | Completed DMC

• 1 other identifier: IRB11-00740
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Gastrointestinal Disorders

Keywords

Antroduodenal manometry; Child; Adolescent; Amoxicillin; Gastrointestinal Motility

Outcome Measures

Primary Outcomes (1)

• Induction of phase III of the migrating motor complex

  The migrating motor complex passes through the GI tract during fasting. It is initially characterized by minimal electrical activity and muscular contraction (phase I), followed by an increase in the frequency of contractions (phase III) and finally a characteristic cluster of contractions (phase III). This cycle occurs only in the fasting state in normal individuals and the frequency of phase III depends on age and the presence of any underlying gastrointestinal dysmotility. The primary outcome is to determine whether amoxicillin can induce phase III of the MMC.

  30 minutes after study drug administration

Secondary Outcomes (3)

• Characteristics of the induced phase III of the migrating motor complex

  Within 6 months after study drug administration during data analysis phase of study

• Patient demographics

  Within 6 months after study drug administration during data analysis phase of study

• Adverse events after study drug administration

  Within 4 hours of study drug administration

Study Arms (2)

Amoxicillin

ACTIVE COMPARATOR

A liquid preparation of amoxicillin will be administered during the study through a nasoduodenal catheter after random patient assignment.

Drug: Amoxicillin

Placebo

PLACEBO COMPARATOR

A liquid placebo will be administered via a nasoduodenal catheter to patients based on random assignment.

Other: Placebo

Interventions

Amoxicillin DRUG

A liquid preparation of amoxicillin will be administered via a nasoduodenal catheter as a one time dose of 20 mg/kg.

Also known as: Amoxil, Amoxicot, DisperMox, Moxilin, Trimox, Moxatag

Amoxicillin

Placebo OTHER

A liquid placebo will be administered via nasoduodenal catheter to patients based on random assignment.

Placebo

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Carlo Di Lorenzo, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 9, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)