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

Launched by UNIVERSITY OF BARI · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how short-term use of proton pump inhibitors (PPIs)—medications commonly given to children to reduce stomach acid for conditions like acid reflux—might affect the natural community of helpful bacteria living in the gut. Since these gut bacteria are important for digestion, immune health, and protecting the gut, the study wants to see if taking PPIs changes this balance in children and adolescents. Understanding these changes can help doctors make better decisions about using these medicines safely during important stages of a child’s development.

Children and teens between 6 months and 17 years old who have been prescribed PPIs for conditions like acid reflux or stomach irritation may be eligible to join. Participants and their families will be asked to provide stool (poop) samples at four different times: before starting the medicine, while taking it, and twice after stopping it. These samples will help researchers track any shifts in gut bacteria over time. The study does not include children who have recently taken antibiotics or probiotics, or who have certain immune or digestive diseases. Families who participate will help improve knowledge about the effects of PPIs on children’s gut health, which could lead to safer and more personalized treatments in the future.

Gender

ALL

Eligibility criteria

• 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.