Lactobacillus Reuteri Strain Combination in Children Treated With PPI
NCT ID: NCT05484128
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
172 participants
INTERVENTIONAL
2020-03-04
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Gastrus
86 patients 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.
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.
Placebo
86 patients 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.
Placebo
placebo has an identical preparation to Gastrus
Interventions
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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.
Placebo
placebo has an identical preparation to Gastrus
Eligibility Criteria
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Inclusion Criteria
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
* 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.
12 Months
14 Years
ALL
No
Sponsors
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University of Bari
OTHER
Responsible Party
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Ruggiero Francavilla
Professor Ruggiero Francavilla
Locations
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Fernanda
Bari, , Italy
Countries
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Central Contacts
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Facility Contacts
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ruggiero Francavilla, Professor
Role: primary
ruggiero francavilla, professor
Role: backup
References
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Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.
Wandall JH. Effects of omeprazole on neutrophil chemotaxis, super oxide production, degranulation, and translocation of cytochrome b-245. Gut. 1992 May;33(5):617-21. doi: 10.1136/gut.33.5.617.
DELLIPIANI AW, GIRDWOOD RH. BACTERIAL CHANGES IN THE SMALL INTESTINE IN MALABSORPTIVE STATES AND IN PERNICIOUS ANAEMIA. Clin Sci. 1964 Jun;26:359-74. No abstract available.
Other Identifiers
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PROBPPI
Identifier Type: -
Identifier Source: org_study_id