Intestinal Microbiota After PPI Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-06

Study Completion Date

2027-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This clinical study aims to investigate the effects of short-term treatment with proton pump inhibitors (PPIs) on the gut microbiota of pediatric patients. PPIs are among the most frequently prescribed medications in children and adolescents for the management of acid-related disorders, such as gastroesophageal reflux disease (GERD). However, emerging evidence suggests that these medications may have unintended consequences on the delicate ecosystem of beneficial microorganisms residing in the human gastrointestinal tract.

The intestinal microbiota plays a pivotal role in modulating immune responses, supporting nutrient metabolism, and maintaining the integrity of the gut barrier. Disruption of this microbial balance-known as dysbiosis-has been associated with several health conditions, including infections, allergies, obesity, and chronic inflammation. In adults, long-term PPI use has been linked to microbiota alterations, but data in the pediatric population remain limited and inconclusive.

To address this gap, our prospective longitudinal study will recruit pediatric patients prescribed PPI therapy for clinical indications. Stool samples will be collected at four time points: prior to PPI administration, during treatment, and at two follow-up stages post-cessation. Using 16S rRNA gene sequencing, we will profile changes in microbial diversity and abundance over time.

The results will offer insight into whether short-term PPI exposure in children leads to significant, lasting changes in gut microbiota composition or diversity. Such information may ultimately inform prescribing practices, support personalized therapeutic strategies, and help mitigate potential risks associated with microbiota disruption during childhood-a critical period for microbial and immune system development.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia

NCT03545243

Dysbiosis

COMPLETED PHASE4

Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

NCT00363701

Dyspepsia Gastroesophageal Refluxdisease Ulcer

UNKNOWN PHASE4

A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on MK-1084 in Healthy Adult Participants (MK-1084-003)

NCT06619314

Healthy

COMPLETED PHASE1

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

NCT04821310

Esophagitis

COMPLETED PHASE2

Effect of Acid Suppression Medication on Pediatric Microbiome

NCT02016820

Clostridium Difficile Infection

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Proton Pump Inhibitors Human Gastrointestinal Tract Gastroesophageal Reflux Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PPI

study of microbiota

Intervention Type OTHER

* Drug: Esomeprazole, a proton pump inhibitor commonly used in pediatric gastroenterology.
* Administration: Oral, once daily, 30 minutes before meals.
* Dosage: Personalized dosing according to body weight, with an average of approximately 0.6 mg/kg/day.
* Treatment duration: Minimum 45 days, maximum 60 days.
* Comparator: None. This is a within-subject design; each participant serves as their own control with baseline samples (t0) compared to follow-up (t1-t2).
* Monitoring: Adherence to therapy and sample collection timeline will be verified during scheduled clinical follow-up.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

study of microbiota

* Drug: Esomeprazole, a proton pump inhibitor commonly used in pediatric gastroenterology.
* Administration: Oral, once daily, 30 minutes before meals.
* Dosage: Personalized dosing according to body weight, with an average of approximately 0.6 mg/kg/day.
* Treatment duration: Minimum 45 days, maximum 60 days.
* Comparator: None. This is a within-subject design; each participant serves as their own control with baseline samples (t0) compared to follow-up (t1-t2).
* Monitoring: Adherence to therapy and sample collection timeline will be verified during scheduled clinical follow-up.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female children and adolescents aged between 6 months and 17 years at the time of enrollment.
* Clinical indication for proton pump inhibitor therapy, including but not limited to gastroesophageal reflux disease, esophagitis, or functional dyspepsia.
* Willingness and ability of the child and their caregivers to comply with all study procedures, including collection of fecal samples at scheduled time points.
* Written informed consent obtained from a parent or legal guardian; assent obtained from the child, when age-appropriate, in accordance with local regulations and ethical standards.

Exclusion Criteria

* Use of systemic antibiotics, antifungals, or probiotics within 30 days prior to the start of the study or during the observation period.
* Incomplete or improperly handled stool sample collection, or failure to adhere to protocol-defined sampling windows.
* Known diagnosis of primary immunodeficiency, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or celiac disease.
* Any condition that, in the opinion of the investigator, may interfere with the integrity of the study or pose additional risks to the participant.

Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No