Using Lactobacillus Reuteri to help children on acid-reducing medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fernanda
  Bari, Italy Recruiting

Study contacts

• Study coordinator: ruggiero francavilla, professor
• Email: ruggiero.francavilla@uniba.it
• Phone: 0805592847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.