Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352697
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-02
Brief Title:
Probiotic Lysate Postbiotic and Metabiotic Supplementation for Adults MASLD Patients DELI_MASLD Study
Sponsor:
Bogomolets National Medical University
Organization:
Bogomolets National Medical University
Study Overview
Official Title:
Efficacy and Safety of Probiotic Lysate Postbiotic and Metabiotic Supplementation in Adults MASLD Patients
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
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:
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces serum lipid profile transaminases activity and chronic systemic inflammatory markers in MASLD patients
The study will include 3 periods Screening period of up to 1 weeks to assess the eligibility to inclusionexclusion criteria Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics cell lysate and DNA fragments of the probiotic strain L rhamnosus DV - NRRLB-68023 at the assigned dose of 100mg or placebo in capsules During this period monthly phone contacts will be done for assessment of compliance and safety concerns Follow-up period of up to 3 month
The study will include 3 periods Screening period of up to 1 weeks to assess the eligibility to inclusionexclusion criteria Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics cell lysate and DNA fragments of the probiotic strain L rhamnosus DV - NRRLB-68023 at the assigned dose of 100mg or placebo in capsules During this period monthly phone contacts will be done for assessment of compliance and safety concerns Follow-up period of up to 3 month
Detailed Description:
The scientific literature points to the beneficial properties of probiotics in the process of regulating metabolism yet at the same time some scientific papers question the effectiveness and the safety of probiotics In turn postbiotics and metabiotics are preparations of inanimate microorganisms and or their components which are directly identified with the safety of their use and the health benefits of the host Due to the chemical structure of postbiotics and metabiotics it is found that they have many health benefits in particular they have a local effect on certain tissues of the intestinal epithelium and influence on many other organs and tissues It is postbiotics metabolites and metabiotics structural cell fragments that create the appearance of a therapeutic effect of probiotics which in turn limits the risk of introducing living microorganisms into a weakened immune defence It should also be pointed out that postbiotics and metabiotics are more stable and have a longer shelf-life
The practical use of probiotics and the study of the mechanism of their action made lately to find that a certain level of biological activity is preserved by dead probiotic cells and even their lysates which are the natural mixes of metabiotic and postbiotic substances a biological activity which is strongly oriented toward gut health and immune system regulation Because probiotic lysates demonstrated biological activity without any of the potential adverse side effects associated with live bacterial cells one of the future goal is research of the novel postbiotics and metabiotics substances their individual structures and biological characteristics for understanding their way of communications with host cells and microbiota representatives
Considering the high biological activity and safety of postbiotics and metabiotic substances it can be concluded that such a treatment vector will be promising in the near future Thatamp39s why our investigation will concentrate on postbiotic a supplement containing dry fermented cell lysate and DNA fragments of the probiotic strain L rhamnosus DV - NRRLB-68023
Recent scientific animal studies on the stated issues point to the benefits of some postbiotics in treating metabolic disorders The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces serum lipid profile transaminases activity and chronic systemic inflammatory markers in MASLD patients
The study will include 3 periods Screening period of up to 1 weeks to assess the eligibility to inclusionexclusion criteria Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics cell lysate and DNA fragments of the probiotic strain L rhamnosus DV - NRRLB-68023 at the assigned dose of 100mg or placebo in capsules All capsules will be identical with similar organoleptic characteristics eg taste and appearance Follow-up period of up to 3 month
The pre-randomization period will be designed to minimize the effects of dietary changes on metabolic markers For this purpose 2 weeks before the study start after inform consent signed patients were instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP In addition participants were instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day
Patients who underwent the study were instructed to take the trial medication as prescribed Throughout the study weekly phone follow-up visits were provided for assessment of compliance adherence to the protocol as well as the recording of adverse events The effectiveness of therapy was compared and evaluated separately in the two groups
The practical use of probiotics and the study of the mechanism of their action made lately to find that a certain level of biological activity is preserved by dead probiotic cells and even their lysates which are the natural mixes of metabiotic and postbiotic substances a biological activity which is strongly oriented toward gut health and immune system regulation Because probiotic lysates demonstrated biological activity without any of the potential adverse side effects associated with live bacterial cells one of the future goal is research of the novel postbiotics and metabiotics substances their individual structures and biological characteristics for understanding their way of communications with host cells and microbiota representatives
Considering the high biological activity and safety of postbiotics and metabiotic substances it can be concluded that such a treatment vector will be promising in the near future Thatamp39s why our investigation will concentrate on postbiotic a supplement containing dry fermented cell lysate and DNA fragments of the probiotic strain L rhamnosus DV - NRRLB-68023
Recent scientific animal studies on the stated issues point to the benefits of some postbiotics in treating metabolic disorders The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces serum lipid profile transaminases activity and chronic systemic inflammatory markers in MASLD patients
The study will include 3 periods Screening period of up to 1 weeks to assess the eligibility to inclusionexclusion criteria Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics cell lysate and DNA fragments of the probiotic strain L rhamnosus DV - NRRLB-68023 at the assigned dose of 100mg or placebo in capsules All capsules will be identical with similar organoleptic characteristics eg taste and appearance Follow-up period of up to 3 month
The pre-randomization period will be designed to minimize the effects of dietary changes on metabolic markers For this purpose 2 weeks before the study start after inform consent signed patients were instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP In addition participants were instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day
Patients who underwent the study were instructed to take the trial medication as prescribed Throughout the study weekly phone follow-up visits were provided for assessment of compliance adherence to the protocol as well as the recording of adverse events The effectiveness of therapy was compared and evaluated separately in the two groups
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