Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04408443
Status:
TERMINATED
Last Update Posted:
2023-03-23
First Post:
2020-05-25
Brief Title:
Evaluation of Lactobacillus Reuteri DSM 17938 Vitamin D3 in the Prevention of RRI in Paediatric Patients
Sponsor:
Noos Srl
Organization:
Noos Srl
Study Overview
Official Title:
Evaluation of a Food Supplement Containing Lactobacillus Reuteri DSM 17938 Vitamin D3 in the Prevention of Recurrent Respiratory Infections in Paediatric Patients
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment due COVID PANDEMIA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LR_D3
Brief Summary:
The aim of this protocol is to evaluate in a multicenter randomized double blind vs placebo clinical trial the effects of a marketed food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 Reuterin D3 in the prevention of recurrent respiratory infections in pediatric patients suffered from Recurrent Respiratory Infection RRI in previous years
Detailed Description:
Several clinical trials documented the efficacy of probiotics in the prevention and treatment of acute gastroenteritis while there is little evidence on the efficacy of the probiotics in the prevention of children respiratory infections
The biological activity of probiotics is linked partly to their capacity to adhere to enterocytes This would avoid the binding of pathogenic bacteria through a competitive exclusion mechanism This inhibition toward pathogen bacteria on epithelial and mucosal level substrate thanks also to the production of antimicrobial substances can have a beneficial effect on the balance of the intestinal microflora of the host and improve its immunity
The adhesion of probiotic bacteria to the enterocyte membrane receptors influences the activation of second messengers that induces the production of cytokines The presence of probiotic bacteria influences the commensal microorganisms in the production of lactic acid and bacteriocins These substances inhibit the growth of pathogens and modify the balance of commensal bacteria of the intestinal bacterial flora
Numerous controlled clinical trials show that L reuteri DSM 17938 colonizes the human gastric and intestinal epithelium and modulates the immune response particularly through CD4 T-helper cells in the ileum These data confirm the pre-clinical evidence obtained in animal models furthermore these immunomodulatory effects may explain some clinical properties of L reuteri DSM 17938 such as the prevention of diarrhea inhibition of pathogen infectionand the following immune system response of the host to these pathogens as well as the potential modulation of the immune response by the Th1Th2 balance in the human intestinal epithelium an answer that has been linked to the prevention and treatment of allergy In a recent randomized double-blind placebo-controlled clinical trial L reuteri DSM 17938 supplemented for three months to healthy children aged 6-36 months attending nursery schools demonstrated not only a significant reduction of episodes and duration of diarrhea but also of respiratory tract infections with consequent reduction of costs for society
Despite the prevalence of food with vitamin D and multivitamin products reports regarding non-optimal vitamin D levels in adults and children in the world have increased in particular among those subjects overweight and with dark pigmentation of the skin
In addition to its well-known effects on bone health vitamin D is indeed an important immune regulator because it stimulates innate immunity and modulates inflammation An analysis of data from the National Health and Nutrition Examination Survey NHANES between 1988 and 1994 showed an inverse relationship between vitamin D levels and the incidence of upper respiratory tract infections URTI These results were supported by other studies showing an increased risk of acute lower respiratory tract infections in subjects with low levels of vitamin D
Historically the association between rickets and the risk of serious respiratory infections is well known and vitamin D deficiency has been associated with an increased risk to contract the flu
These considerations have led to the hypothesis that supplementation with a probiotic added with vitamin D3 may influence the composition of intestinal flora by improving the immune system and therefore reducing episodes of respiratory infections particularly frequent during preschool age
The biological activity of probiotics is linked partly to their capacity to adhere to enterocytes This would avoid the binding of pathogenic bacteria through a competitive exclusion mechanism This inhibition toward pathogen bacteria on epithelial and mucosal level substrate thanks also to the production of antimicrobial substances can have a beneficial effect on the balance of the intestinal microflora of the host and improve its immunity
The adhesion of probiotic bacteria to the enterocyte membrane receptors influences the activation of second messengers that induces the production of cytokines The presence of probiotic bacteria influences the commensal microorganisms in the production of lactic acid and bacteriocins These substances inhibit the growth of pathogens and modify the balance of commensal bacteria of the intestinal bacterial flora
Numerous controlled clinical trials show that L reuteri DSM 17938 colonizes the human gastric and intestinal epithelium and modulates the immune response particularly through CD4 T-helper cells in the ileum These data confirm the pre-clinical evidence obtained in animal models furthermore these immunomodulatory effects may explain some clinical properties of L reuteri DSM 17938 such as the prevention of diarrhea inhibition of pathogen infectionand the following immune system response of the host to these pathogens as well as the potential modulation of the immune response by the Th1Th2 balance in the human intestinal epithelium an answer that has been linked to the prevention and treatment of allergy In a recent randomized double-blind placebo-controlled clinical trial L reuteri DSM 17938 supplemented for three months to healthy children aged 6-36 months attending nursery schools demonstrated not only a significant reduction of episodes and duration of diarrhea but also of respiratory tract infections with consequent reduction of costs for society
Despite the prevalence of food with vitamin D and multivitamin products reports regarding non-optimal vitamin D levels in adults and children in the world have increased in particular among those subjects overweight and with dark pigmentation of the skin
In addition to its well-known effects on bone health vitamin D is indeed an important immune regulator because it stimulates innate immunity and modulates inflammation An analysis of data from the National Health and Nutrition Examination Survey NHANES between 1988 and 1994 showed an inverse relationship between vitamin D levels and the incidence of upper respiratory tract infections URTI These results were supported by other studies showing an increased risk of acute lower respiratory tract infections in subjects with low levels of vitamin D
Historically the association between rickets and the risk of serious respiratory infections is well known and vitamin D deficiency has been associated with an increased risk to contract the flu
These considerations have led to the hypothesis that supplementation with a probiotic added with vitamin D3 may influence the composition of intestinal flora by improving the immune system and therefore reducing episodes of respiratory infections particularly frequent during preschool age
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