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RECRUITING
NCT05484128
NA

Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Sponsor: University of Bari

View on ClinicalTrials.gov

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.

Official title: Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors

Key Details

Gender

All

Age Range

12 Months - 14 Years

Study Type

INTERVENTIONAL

Enrollment

172

Start Date

2020-03-04

Completion Date

2025-12-31

Last Updated

2024-12-05

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Gastrus

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.

OTHER

Placebo

placebo has an identical preparation to Gastrus

Locations (1)

Fernanda

Bari, Italy