Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 172
- Locations
- 2
- Primary Endpoint
- Variation in results of Health Questionnaire for Data Collection
Study Overview
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:
- reduces the incidence of SIBO;
- reduces the risk of infections in children treated with gastric-acid inhibitors;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
nobody knows the randomization code
Eligibility Criteria
- Ages
- 12 Months to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Variation in results of Health Questionnaire for Data Collection
Time Frame: at baseline and weekly until week 14
A diary will be given to the parents, with instructions to report the following: systemic symptoms including fever, headache, restless, myalgia, irritability; gastrointestinal or respiratory symptoms; use of drugs (antibiotics, antipyretics, steroids); emergency department medical examinations; hospitalizations; possible adverse events; consumption of the study products; school days lost by the children; working days lost by the parents.
Variation in Lactulose breath test results
Time Frame: at baseline and week 10
This study aimed at investigating if Gastrus administration prevents the emergence of SIBO in children treated with proton pump inhibitors. This test will be performed to assess the presence of SIBO before PPI treatment and at week 10 (end of PPI treatment).
Secondary Outcomes
- fecal analysis(14 weeks)
- Gastrointestinal Symptom Rating Scale (GSRS).(14 weeks)
Investigators
Ruggiero Francavilla
Professor Ruggiero Francavilla
University of Bari