Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Gastric Lesion, Proton Pump Inhibitor Adverse Reaction, Probiotic

In brief

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.

Key facts

Study ID

NCT05484128

Run by

University of Bari

People needed

172

Starts

2020-03-04

Expected to finish

2025-12-31

Last updated by the study team

2024-12-05

Who can join

Age: 1 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Fernanda — Bari, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.