Trial Outcomes & Findings for Effect of Acid Suppression Medication on Pediatric Microbiome (NCT NCT02016820)

NCT ID: NCT02016820

Last Updated: 2023-12-26

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

From week 12 to week 4

Results posted on

2023-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Omeprazole (Suspension) Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day	Lifestyle Modification Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed
Overall Study STARTED	3	4
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Omeprazole (Suspension) Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day	Lifestyle Modification Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

Effect of Acid Suppression Medication on Pediatric Microbiome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omeprazole (Suspension) n=3 Participants Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day	Lifestyle Modification n=4 Participants Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	3 participants n=93 Participants	4 participants n=4 Participants	7 participants n=27 Participants

PRIMARY outcome

Timeframe: From week 12 to week 4

Population: Zero participants analyzed as only 1 participant completed. Data was not analyzed and is not included here to protect the confidentiality of this one participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 64

Population: Zero participants analyzed as only 1 participant completed. Data was not analyzed and is not included here to protect the confidentiality of this one participant.

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.

Outcome measures

Outcome data not reported

Adverse Events

Omeprazole (Suspension)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lifestyle Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel E. Freedberg, MD, MS

Columbia University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place