NCT07036627

Intestinal Microbiota After PPI Treatment

Evaluation of the Intestinal Microbiota in Pediatric Patients Treated With Proton Pump Inhibitors: A Prospective Longitudinal Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Proton Pump Inhibitors
• Human Gastrointestinal Tract
• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-07-06
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2025-06-25
• Last updated: 2025-06-29

Locations

1 site across 1 country: Italy