Effect of Acid Suppression Medication on Pediatric Microbiome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02016820
Recruitment Status : Unknown
Verified May 2016 by Daniel Freedberg, Columbia University.
Recruitment status was:  Recruiting
First Posted : December 20, 2013
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Daniel Freedberg, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Omeprazole (suspension) Other: Lifestyle Modification Not Applicable

Detailed Description:
Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children
Study Start Date : November 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Omeprazole (suspension)
Open-label, with all subjects receiving omeprazole
Drug: Omeprazole (suspension)
1 mg/kg/day
Other Name: As above

Lifestyle Modification
Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)
Other: Lifestyle Modification
Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed

Primary Outcome Measures :
  1. Change in fecal microbiome diversity, assessed by Bray-Curtis Index comparing those who received acid suppression medications to those who received lifestyle modifications [ Time Frame: From week 12 to week 4 ]

Secondary Outcome Measures :
  1. % subjects eating high fiber diet [ Time Frame: Up to Week 64 ]
    At each study visit, we will assess the effects of longterm diet on the microbiome by using the Harvard-Willett Food Frequency Questionnaire. Using this data, we will classify each subject as low vs high fiber.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Zero to 4 years old
  • Being considered for PPI or H2RA treatment for refractory GERD
  • Parent is able to give informed consent

Exclusion Criteria:

  • Prevalent C. difficile infection (excluded via stool PCR at week 0)
  • Use of systemic antibiotics within the past 90 days
  • Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
  • Increased risk for fracture due to vitamin D deficiency or other causes
  • Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
  • Congenital deficiency in immunity (e.g., such as IgA deficiency)
  • Cystic fibrosis
  • Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
  • Use of medications with potential interaction with PPIs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02016820

Contact: Daniel E Freedberg, MD, MS 212-342-0238

United States, New York
Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
Contact: Daniel E Freedberg, MD    212-342-0238   
Sub-Investigator: Esi SN Lamouse-Smith, MD, PhD         
Sponsors and Collaborators
Columbia University
Principal Investigator: Julian S Abrams, MD, MS Columbia University
Principal Investigator: Daniel E Freedberg, MD, MS Columbia University

Responsible Party: Daniel Freedberg, Assistant Professor of Medicine, Department: Medicine Digestive & Liver Diseases, Columbia University Identifier: NCT02016820     History of Changes
Other Study ID Numbers: AAAM9955
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Daniel Freedberg, Columbia University:
Clostridium Difficile Infection
Proton Pump Inhibitors
Histamine-2 Receptor Antagonists
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action