RecruitingNot Applicable

Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Italy172 participantsStarted 2020-03-04

Plain-language 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.

Who can participate

Age range12 Months – 14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Variation in Lactulose breath test results

Timeframe: at baseline and week 10

Variation in results of Health Questionnaire for Data Collection

Timeframe: at baseline and weekly until week 14

Trial details

NCT IDNCT05484128

SponsorUniversity of Bari

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

ruggiero francavilla, professor

0805592847 ruggiero.francavilla@uniba.it

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