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Effect of Acid Suppression Medication on Pediatric Microbiome

Primary Purpose

Clostridium Difficile Infection

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Omeprazole (suspension)

Lifestyle Modification

About this trial

This is an interventional basic science trial for Clostridium Difficile Infection focused on measuring Clostridium Difficile Infection, Proton Pump Inhibitors, Histamine-2 Receptor Antagonists, Gastroesophageal Reflux Disease

Eligibility Criteria

undefined - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Morgan Stanley Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Omeprazole (suspension)

Lifestyle Modification

Arm Description

Open-label, with all subjects receiving omeprazole

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

Outcomes

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

% subjects eating high fiber diet

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.

Full Information

NCT ID

NCT02016820

First Posted

December 16, 2013

Last Updated

May 10, 2016

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT02016820

Brief Title

Effect of Acid Suppression Medication on Pediatric Microbiome

Official Title

Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile Infection

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omeprazole (suspension)

Arm Type

Experimental

Arm Description

Open-label, with all subjects receiving omeprazole

Arm Title

Lifestyle Modification

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omeprazole (suspension)

Other Intervention Name(s)

As above

Intervention Description

1 mg/kg/day

Intervention Type

Other

Intervention Name(s)

Lifestyle Modification

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

% subjects eating high fiber diet

Description

Time Frame

Up to Week 64

10. Eligibility

Sex

All

Maximum Age & Unit of Time

4 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel E Freedberg, MD, MS

Phone

212-342-0238

def2004@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julian S Abrams, MD, MS

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel E Freedberg, MD, MS

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Morgan Stanley Children's Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel E Freedberg, MD

Phone

212-342-0238

def2004@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Esi SN Lamouse-Smith, MD, PhD

12. IPD Sharing Statement

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Effect of Acid Suppression Medication on Pediatric Microbiome

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