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
Study 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
Sex
ALL
Min age
12 Months
Max age
14 Years
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.
Primary outcome measure(s)
Variation in Lactulose breath test results — 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).
Variation in results of Health Questionnaire for Data Collection — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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