Using Lactobacillus Reuteri to help children on acid-reducing medications
Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors
This study is testing if a probiotic called Gastrus can help children taking acid-reducing medications stay healthy by reducing gut issues and infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 12 Months to 14 Years |
| Sex | All |
| Sponsor | University of Bari Academic / other |
| Locations | 1 site (Bari) |
| Trial ID | NCT05484128 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a probiotic combination, Gastrus, containing two strains of Lactobacillus reuteri, on children who are being treated with proton pump inhibitors (PPIs). The primary goals are to determine if Gastrus can reduce the incidence of small intestinal bacterial overgrowth (SIBO), lower the risk of infections, and maintain gut microbiota balance during PPI therapy. Participants will receive either Gastrus or a placebo for eight weeks, with follow-up evaluations conducted after treatment cessation. Compliance will be monitored through alarms to ensure participants take the required doses.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 month to 14 years who need PPI therapy for gastroesophageal reflux disease or functional dyspepsia.
Not a fit: Patients with neurological disorders, known immunodeficiencies, or those who have recently taken other probiotics or prebiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve gut health and reduce infection risks in children requiring long-term PPI therapy.
How similar studies have performed: Previous studies have shown promising results with probiotics in managing gut health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: children between 1 month and 14 years of age; o We start with children older than 4 years of age. * Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and/or Functional Dyspepsia; * Informed consent obtained. Exclusion Criteria: * Neurological pathologies (PCI and Spastic tetra-paresis); * Nasogastric feeding; * Known immunodeficiency; * Previous therapy with gastric acid inhibitors; * HP infection; * Assumption of prebiotics, other probiotics or symbiotics in the previous month; * Malnutrition or severe dystrophy; * Cystic Fibrosis.
Where this trial is running
Bari
- Fernanda — Bari, Italy (Recruiting)
Study contacts
- Study coordinator: ruggiero francavilla, professor
- Email: ruggiero.francavilla@uniba.it
- Phone: 0805592847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.