Lactobacillus Reuteri Strain Combination in Children Treated With PPI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-14
SponsorUniversity of Bari
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: children between 1 month and 14 years of age;
Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and/or Functional Dyspepsia;
Informed consent obtained.
Disqualifiers
Neurological pathologies (PCI and Spastic tetra-paresis);
Nasogastric feeding;
Known immunodeficiency;
Previous therapy with gastric acid inhibitors;
Trial design
Design model
Parallel
Treatments tested in this trial
Gastrus
Dietary supplementGastrus 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
Other interventionplacebo has an identical preparation to Gastrus
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: GastrusExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Variation in Lactulose breath test results
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).
Time frame
at baseline and week 102
Variation in results of Health Questionnaire for Data Collection
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.
Time frame
at baseline and weekly until week 14Secondary outcomes
1
fecal analysis
Ability of Gastrus to prevent and control gut microbiota alteration. Fecal samples for microbiological analysis will be collected before PPI treatment and at week 4, week 10 (end of PPI treatment) and week 14 (4 weeks after PPI discontinuation). The gas-chromatography mass spectrometry-solid-phase microextraction (GC-MS/SPME) analysis of fecal volatile compounds will be also performed.
Time frame
14 weeks2
Gastrointestinal Symptom Rating Scale (GSRS).
Participants will be asked to fill out the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire after inclusion but before taking the first dose of study product, every 2 weeks during treatment, and 2 weeks after stopping PPI. The GSRS is composed by 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Subjects rated the relevance and importance of each of the 15 GSRS items using the following scale: 0 = Totally irrelevant 1. = Relevant but not important 2. = Moderately important 3. = Very important Higher scores indicate greater severity.
Time frame
14 weeksSponsors and contacts
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Source ClinicalTrials.gov