Effect of Acid Suppression Medication on Pediatric Microbiome

NCT02016820 | Terminated Results

• 1 other identifier: AAAM9955
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium Difficile Infection; Proton Pump Inhibitors; Histamine-2 Receptor Antagonists; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications

  From week 12 to week 4

Secondary Outcomes (1)

• Percent Subjects Eating High Fiber Diet

  Up to Week 64

Study Arms (2)

Omeprazole (suspension)

EXPERIMENTAL

Open-label, with all subjects receiving omeprazole

Drug: Omeprazole (suspension)

Lifestyle Modification

OTHER

Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)

Other: Lifestyle Modification

Interventions

Omeprazole (suspension) DRUG

1 mg/kg/day

Also known as: As above

Omeprazole (suspension)

Lifestyle Modification OTHER

Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed

Lifestyle Modification

Eligibility Criteria

• Age: 0 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Clostridium Infections; Gastroesophageal Reflux

Interventions

Omeprazole; Suspensions

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Daniel E. Freedberg, MD, MS
• Organization: Columbia University

def2004@cumc.columbia.edu

Study Officials

• Julian S Abrams, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

• Daniel E Freedberg, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: November 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Locations

US (1)