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Lactobacillus Reuteri Strain Combination in Children Treated With PPI

NCT05484128 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • Gastric Lesion
  • Proton Pump Inhibitor Adverse Reaction
  • Probiotic

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

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484128 on ClinicalTrials.gov