Lactobacillus Reuteri Strain Combination in Children Treated With PPI
Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors
University of Bari
172 participants
Mar 4, 2020
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria8
- 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.
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Interventions
Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475. Gastrus will be administered for all the duration of PPI administration (8 weeks) plus two weeks after its discontinuation. A final evaluation will be performed 4 weeks after the discontinuation of both Gastrus.
placebo has an identical preparation to Gastrus
Locations(1)
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NCT05484128