Clinical trial NCT05484128: Lactobacillus Reuteri Strain Combination in Children Treated With PPI
Official title: Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Lesion
Proton Pump Inhibitor Adverse Reaction
Probiotic
Keywords: Reuteri
Proton Pump Inhibitor
gastrus
infections
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double bind with placebo
Primary purpose: PREVENTION

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.

Detailed 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.

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.

Primary outcomes:
measure: Variation in Lactulose breath test results
timeFrame: at baseline and week 10
measure: Variation in results of Health Questionnaire for Data Collection
timeFrame: at baseline and weekly until week 14
Secondary outcomes:
measure: fecal analysis
timeFrame: 14 weeks
measure: Gastrointestinal Symptom Rating Scale (GSRS).
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Fernanda
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.