Lactobacillus Reuteri Strain Combination in Children Treated With PPI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-14
SponsorUniversity of Bari
About this trial
Probiotics might be of help in preventing dysbiosis and emergence of SIBO. Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475; the first have extensive data supporting its use in gastric infections (18) however, it lacks the anti-inflammatory properties that have been provided by L. Reuteri DSM ATCC PTA 6475 that has excellent acid resistance and has strong anti-inflammatory properties (19); for these reasons, Gastrus is the best candidate for this indication.
Eligibility criteria
Qualifiers
Age: children between 1 month and 14 years of age;
Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and/or Functional Dyspepsia;
Informed consent obtained.
Disqualifiers
Neurological pathologies (PCI and Spastic tetra-paresis);
Nasogastric feeding;
Known immunodeficiency;
Previous therapy with gastric acid inhibitors;
Trial design
Treatments tested in this trial
- Gastrus
- Placebo
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov