Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04408443 |
| Other study ID # |
IRR_D3 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2019 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
Noos S.r.l. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 Th1/Th2 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.
