An observational study in Proton Pump Inhibitors, Human Gastrointestinal Tract and Gastroesophageal Reflux Disease, sponsored by University of Bari. Not yet recruiting at 1 site in Italy. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by University of Bari · Observational
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 100 is below the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
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Population with GERD
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PPI
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.
Changes in microbiota
* Definition: Change in the relative abundance of key bacterial families (Streptococcaceae, Ruminococcaceae, Clostridiales, etc.) from t0 to t1. * Methodology: High-throughput 16S rRNA gene sequencing (regions V3-V4) using the Illumina MiSeq platform; taxonomic assignment via the SILVA reference database. * Justification: These bacterial families have been previously associated with dysbiosis and PPI-related shifts in microbial composition.
Time frame: 60 days from baseline
Microbial diversity
* Alpha-diversity: Within-sample microbial diversity measured by Shannon's entropy and Chao1 richness estimator. * Beta-diversity: Between-sample differences using Bray-Curtis dissimilarity; visualized via principal coordinates analysis (PCoA). * Differential abundance: Identification of statistically enriched or depleted taxa using LEfSe (Linear Discriminant Analysis Effect Size). * Clinical correlation: Incidence of gastrointestinal (e.g., diarrhea, abdominal pain) and respiratory symptoms (e.g., cough, wheezing) reported during or after therapy.
Time frame: 60 days from baseline.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of Bari