Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Aim of study Our aims are to assess if Gastrus administration: 1. reduces the incidence of SIBO; 2. reduces the risk of infections in children treated with gastric-acid inhibitors; 3. prevents perturbation of gut microbiota and related dysbiosis; Study Product Gastrus sachets/chewable caps: 2x108 CFU Lactobacillus reuteri DSM 17938 + 2x108 CFU Lactobacillus reuteri ATCC PTA 6475. Placebo sachets/chewable caps: Identical in shape, colour and taste to Gastrus capsules but without the Lactobacillus reuteri components. Both study products are delivered in identical containers. Dosing: Two sachets/cps twice a day. Length of treatment: Gastrus or placebo 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 and placebo. Compliance, PP and ITT To be considered compliant the participant should have consumed at leas 80% of the doses. In order to improve compliance, the participants will be equipped with alarm-devices. Compliant patients will be assessed as Per-Protocol (PP). Patients that are non-compliant will be included in the Intention-To-Treat analysis. Outcomes Primary efficacy parameter This study aimed at investigating if Gastrus administration prevents the emergence of SIBO and reduces the risk of infections in children treated with proton pump inhibitors and. Exploratory parameters Ability of Gastrus to prevent and control gut microbiota alteration; Ability of Gastrus to improve GI symptoms for which the drug has been prescribed. Sample size calculation Assuming that the average rate of infection in patient who assume PPI is 32% as compared to 9% of those who do not use the drug (16), to demonstrate an efficacy of the probiotic, keeping a power of the study of 80% and a p of 0,05 we need 78 patients for group that, considering a drop out of 10%, will became 86 per group (patient younger/older 4 years of age:0,75) This sample size is by far larger than needed to demonstrate the preventive effect on SIBO emergence. ;

Study Design

Related Conditions & MeSH terms

Gastric Lesion
Probiotic
Proton Pump Inhibitor Adverse Reaction
Sprains and Strains

Clinical Trial Details

NCT number	NCT05484128
Study type	Interventional
Source	University of Bari
Contact	ruggiero francavilla, professor
Phone	0805592847
Email	ruggiero.francavilla@uniba.it
Status	Recruiting
Phase	N/A
Start date	March 4, 2020
Completion date	December 31, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.