Actively Recruiting

Phase Not Applicable
Age: 12Months - 14Years
All Genders
NCT05484128

Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Led by University of Bari · Updated on 2024-12-05

172

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Who Can Participate

Age: 12Months - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children between 1 month and 14 years old
  • Need for proton pump inhibitor therapy for gastroesophageal reflux disease or functional dyspepsia
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • Neurological disorders such as perinatal cerebral injury or spastic tetraparesis
  • Nasogastric feeding
  • Known immunodeficiency
  • Previous therapy with gastric acid inhibitors
  • Helicobacter pylori infection
  • Use of prebiotics, probiotics, or symbiotics in the past month
  • Malnutrition or severe dystrophy
  • Cystic fibrosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fernanda

Bari, Italy, 70100

Actively Recruiting

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Research Team

R

ruggiero francavilla, professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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