NCT05484128 Lactobacillus Reuteri Strain Combination in Children Treated With PPI
| NCT ID | NCT05484128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bari |
| Condition | Gastric Lesion |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2020-03-04 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 172 participants in total. It began in 2020-03-04 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05484128 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 14 Years, studying Gastric Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05484128 currently recruiting?
Yes, NCT05484128 is actively recruiting participants. Contact the research team at ruggiero.francavilla@uniba.it for enrollment information.
Where is the NCT05484128 trial being conducted?
This trial is being conducted at Bari, Italy.
Who is sponsoring the NCT05484128 clinical trial?
NCT05484128 is sponsored by University of Bari. The trial plans to enroll 172 participants.