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Proton Pump Inhibitor

Lifestyle Modification for Clostridium Difficile Infection

N/A
Waitlist Available
Led By Julian S Abrams, MD, MS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 12 to week 4
Awards & highlights

Study Summary

The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.

Eligible Conditions
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 12 to week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 to week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications
Secondary outcome measures
Percent Subjects Eating High Fiber Diet

Trial Design

2Treatment groups
Experimental Treatment
Group I: Omeprazole (suspension)Experimental Treatment1 Intervention
Open-label, with all subjects receiving omeprazole
Group II: Lifestyle ModificationExperimental Treatment1 Intervention
Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,451,008 Total Patients Enrolled
Julian S Abrams, MD, MSPrincipal InvestigatorColumbia University
Daniel E Freedberg, MD, MSPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
90 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
Effect of Acid Suppression Medication on Pediatric Microbiome
Julian A Abrams, MD 2014. "Effect of Acid Suppression Medication on Pediatric Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02016820.
~1 spots leftby Apr 2025
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