Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836013
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2021-03-20
Brief Title:
Combined Lactobacilli Reuteri LMG P-27481 and GG ATCC 53103 to Prevent Antibiotic Associated Symptoms in Children
Sponsor:
Università degli Studi dellInsubria
Organization:
Università degli Studi dellInsubria
Study Overview
Official Title:
Multicenter Randomized Trial of a Combined Probiotic Lactobacillus Reuteri LMG P-27481 and Lactobacillus Rhamnosus GG ATCC 53103 for the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms in Children
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicenter pediatric double-blind randomized placebo-controlled parallel group clinical trial intended to evaluate the efficacy safety and tolerability of a combined probiotic LGG and L reuteri LMG P-27481 in the prevention of antibiotic associated diarrhea and gastrointestinal symptoms in hospitalised children treated with antibiotics for proven or suspected bacterial infection
Detailed Description:
Eligible children will be randomly assigned to receive the combined probiotic study product Noos Roma ItaliaBCCMTM Bacterial Collection of Ghent Belgium Italian Patent 102016000011071 International Patent Request PCTIB 2017053856 or placebo as additional treatment to the antibiotic therapy Kind dose and duration of antibiotic treatment will be decided by the local clinicians according to good medical practice and current recommendations The first dose of probiotic will be started the same day of starting the antibiotic treatment immediately after enrollment Then each oral stick will be administered orally once daily in the morning before breakfast during the antibiotic treatment and prolonged for 30 days since starting
Study product The combined probiotic is made by Lactobacillus reuteri LMG P-27481 and Lactobacillus rhamnosus GG ATCC 53103 sucralose and isomalt as an oral stick formulation of 16 g with a concentration of probiotic of 2x1010 colony forming unit CFU per stick launched in the Italian market with the name of ReuterinGG Noos Roma Italia
The probiotic and placebo will be prepared centrally by the probiotic producer as identically appearing oral stick The placebo will contain only sucralose and isomalt 16 g per stick
Randomization The allocation sequences and randomization lists has been generated by a online computer system The probiotic -placebo allocation ratio will be of 11 To ensure allocation concealment an independent subject prepared the randomization schedule and sealed envelopes to be sent to the participant centers Each investigator will control the packaging and labels of trial treatments sent by the producer with a numerical code with no possible identification of the probiotic product compared to the placebo The allocation will be consecutively assigned for all enrolled subjects All investigators participants and statisticians will be blinded to the assigned treatment throughout the study and during the data analysis After completing the analysis of the data or in case of sever adverse event the randomization code will be broken and information about the content of the product probiotic or placebo will be revealed by the producer upon the investigators request
Monitoring and collection of data At enrollment a standardized form will record age gender anthropometric parameters vital signs refilling time site of infection laboratory tests kind dose and route of administration of antibiotic diet previous AAD or other gastrointestinal symptoms comorbidity and associated treatment Vesikary scale anthropometric measures vital signs refilling time will be also recorded in each patient at enrollment and in case of occurrence of diarrhea Bristol stool chart will be used to grade the consistency of stools
Parents or care givers of each children will be instructed to fill in a diary to record the duration of antibiotic treatment andor other treatment the intake of the study product the frequency of daily bowel movements the consistency of stools according to the Bristol stool scale the frequency and intensity according to a VAS scale from 0 to 10 of abdominal pain the presence and duration of fever vomiting or any other symptoms they considered important diet changes and general well being according to a numerical 1-10 scale The diary will be completed daily for the duration of the probiotic treatment and then weekly till the end of the study After discharge from the hospital the absence from day care or school the need of new antibiotic treatment or re-hospitalization will be also noted In case of diarrhea fever or other severe symptoms after hospital discharge parents will be instructed to contact the local pediatrician and investigator for clinical evaluation and stool analysis A clinical visit will be scheduled in all recruited patients after 1 3 and 6 months from enrollment
Re-hospitalization will be required in case of severe infection severe dehydration or whenever considered necessary by clinicians
Scheduled investigations In all cases presenting diarrhea at least three stool samples will be collected and stool tests will be performed to detect viral bacterial or C difficile pathogens Blood and urine test or radiologial investigations will be decided by the local clinician based on patients clinical presentation and according to guidelines and good clinical practice
One additional sample of stools will be collected whenever possible in each patient at enrollment at 1 3 and 6 months to evaluate fecal calprotectin to indirectly assess intestinal inflammation In a subgroup of patients the first 30 recruited in each arms two other stool samples and a urine sample will be collected and stocked in freezer -20 C at the same study point for possible future additional explorative analysis of fecal inflammatory markers lactoferrine IgA IL10 and TNF-α and metabolomic profile urine metabolites
The probiotic producer Noos SrL Roma Italia will gift the probiotic product and placebo for the duration of the study for all children enrolled but has and will have no role in the design and conduct of the study collection management analysis or interpretation of the data preparation review or approval of the manuscript or the decision to submit the manuscript for publication The data of the enrolled subjects will be managed stored and property of the clinical investigators of the participant centers and of the coordinator center and will be analysed and published anonymously and as aggregate in the respect of the current legislation on privacy
Study product The combined probiotic is made by Lactobacillus reuteri LMG P-27481 and Lactobacillus rhamnosus GG ATCC 53103 sucralose and isomalt as an oral stick formulation of 16 g with a concentration of probiotic of 2x1010 colony forming unit CFU per stick launched in the Italian market with the name of ReuterinGG Noos Roma Italia
The probiotic and placebo will be prepared centrally by the probiotic producer as identically appearing oral stick The placebo will contain only sucralose and isomalt 16 g per stick
Randomization The allocation sequences and randomization lists has been generated by a online computer system The probiotic -placebo allocation ratio will be of 11 To ensure allocation concealment an independent subject prepared the randomization schedule and sealed envelopes to be sent to the participant centers Each investigator will control the packaging and labels of trial treatments sent by the producer with a numerical code with no possible identification of the probiotic product compared to the placebo The allocation will be consecutively assigned for all enrolled subjects All investigators participants and statisticians will be blinded to the assigned treatment throughout the study and during the data analysis After completing the analysis of the data or in case of sever adverse event the randomization code will be broken and information about the content of the product probiotic or placebo will be revealed by the producer upon the investigators request
Monitoring and collection of data At enrollment a standardized form will record age gender anthropometric parameters vital signs refilling time site of infection laboratory tests kind dose and route of administration of antibiotic diet previous AAD or other gastrointestinal symptoms comorbidity and associated treatment Vesikary scale anthropometric measures vital signs refilling time will be also recorded in each patient at enrollment and in case of occurrence of diarrhea Bristol stool chart will be used to grade the consistency of stools
Parents or care givers of each children will be instructed to fill in a diary to record the duration of antibiotic treatment andor other treatment the intake of the study product the frequency of daily bowel movements the consistency of stools according to the Bristol stool scale the frequency and intensity according to a VAS scale from 0 to 10 of abdominal pain the presence and duration of fever vomiting or any other symptoms they considered important diet changes and general well being according to a numerical 1-10 scale The diary will be completed daily for the duration of the probiotic treatment and then weekly till the end of the study After discharge from the hospital the absence from day care or school the need of new antibiotic treatment or re-hospitalization will be also noted In case of diarrhea fever or other severe symptoms after hospital discharge parents will be instructed to contact the local pediatrician and investigator for clinical evaluation and stool analysis A clinical visit will be scheduled in all recruited patients after 1 3 and 6 months from enrollment
Re-hospitalization will be required in case of severe infection severe dehydration or whenever considered necessary by clinicians
Scheduled investigations In all cases presenting diarrhea at least three stool samples will be collected and stool tests will be performed to detect viral bacterial or C difficile pathogens Blood and urine test or radiologial investigations will be decided by the local clinician based on patients clinical presentation and according to guidelines and good clinical practice
One additional sample of stools will be collected whenever possible in each patient at enrollment at 1 3 and 6 months to evaluate fecal calprotectin to indirectly assess intestinal inflammation In a subgroup of patients the first 30 recruited in each arms two other stool samples and a urine sample will be collected and stocked in freezer -20 C at the same study point for possible future additional explorative analysis of fecal inflammatory markers lactoferrine IgA IL10 and TNF-α and metabolomic profile urine metabolites
The probiotic producer Noos SrL Roma Italia will gift the probiotic product and placebo for the duration of the study for all children enrolled but has and will have no role in the design and conduct of the study collection management analysis or interpretation of the data preparation review or approval of the manuscript or the decision to submit the manuscript for publication The data of the enrolled subjects will be managed stored and property of the clinical investigators of the participant centers and of the coordinator center and will be analysed and published anonymously and as aggregate in the respect of the current legislation on privacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None