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The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carlo Di Lorenzo, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01530009
First received: February 7, 2012
Last updated: July 24, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Functional Gastrointestinal Disorders Drug: Amoxicillin Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

Resource links provided by NLM:


Further study details as provided by Carlo Di Lorenzo, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Induction of phase III of the migrating motor complex [ Time Frame: 30 minutes after study drug administration ]
    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.


Secondary Outcome Measures:
  • Characteristics of the induced phase III of the migrating motor complex [ Time Frame: Within 6 months after study drug administration during data analysis phase of study ]
    Characteristics of the induced phase III of the migrating motor complex will be analyzed.

  • Patient demographics [ Time Frame: Within 6 months after study drug administration during data analysis phase of study ]
    Patient demographics including age, gender, symptoms and underlying diagnosis will be analyzed in both study groups and compared.

  • Adverse events after study drug administration [ Time Frame: Within 4 hours of study drug administration ]
    Any adverse events within 4 hours of study drug administration will be recorded and analyzed.


Estimated Enrollment: 26
Study Start Date: January 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amoxicillin
A liquid preparation of amoxicillin will be administered during the study through a nasoduodenal catheter after random patient assignment.
Drug: Amoxicillin
A liquid preparation of amoxicillin will be administered via a nasoduodenal catheter as a one time dose of 20 mg/kg.
Other Names:
  • Amoxil
  • Amoxicot
  • DisperMox
  • Moxilin
  • Trimox
  • Moxatag
Placebo Comparator: Placebo
A liquid placebo will be administered via a nasoduodenal catheter to patients based on random assignment.
Other: Placebo
A liquid placebo will be administered via nasoduodenal catheter to patients based on random assignment.

Detailed Description:

Motility disorders are common in childhood and can present with a variety of symptoms including recurrent vomiting, abdominal pain and distension. They are often the reason for multiple medical visits and can be associated with significantly impaired quality of life in severe cases. There are a limited number of available medications used to improve motility in the stomach and small bowel, which include dopamine-receptor antagonists, serotonergic agents and antibiotics such as erythromycin. Among the latter group, amoxicillin-clavulanate (AMC) has been shown to enhance fasting small intestinal motility in adults and children. The mechanism of action is not currently known though theories include indirect release of an intraluminal mediator such as motilin, or direct interaction of the β-lactam moiety with γ-aminobutyric acid receptors in the myenteric plexus.

AMC is a combination of amoxicillin (AMX) with clavulanic acid (CA), a β-lactamase inhibitor. This modification of the drug results in a broader spectrum of antibacterial activity to include AMX sensitive and β-lactamase-producing strains. Although both AMX and AMC are generally well tolerated, AMX can be associated with fewer adverse effects due to the presence of the CA moiety in AMC. AMC is associated with a higher frequency of nausea, vomiting and transient diarrhea compared to AMX. In a study of outpatient children, patients on AMC have been shown to have an increased risk of antibiotic-associated diarrhea. Drug-related liver injury is also more common in patients taking AMC. Furthermore, it is advisable to use the most narrow spectrum antibiotic that demonstrates clinical efficacy in light of the emergence of β-lactam-β-lactamase inhibitor-resistant bacterial strains accelerated by excess antibiotic use.

AMX has a good safety profile and is frequently prescribed for children by community physicians based on history and physical examination alone. It is the recommended first line treatment in common childhood illnesses such as upper respiratory infections, including ear and sinus infections, and community-acquired pneumonia.

The goal of this study is to determine whether a single dose of AMX 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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530009

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Carlo Di Lorenzo, MD Nationwide Children's Hospital
  More Information

Responsible Party: Carlo Di Lorenzo, Pediatric Gastroenterologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01530009     History of Changes
Other Study ID Numbers: IRB11-00740
Study First Received: February 7, 2012
Last Updated: July 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Carlo Di Lorenzo, Nationwide Children's Hospital:
Antroduodenal manometry
Child
Adolescent
Amoxicillin
Gastrointestinal Motility

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017