Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05804422 |
| Other study ID # |
DELI_NAFLD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Bogomolets National Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
MRI-PDFF and ultrasonography, liver stiffness (LS) measured by Shear Wave Elastography (SWE)
and anthropomorphic variables in NAFLD patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility
to inclusion/exclusion 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.
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. That's
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 MRI-PDFF and ultrasonography, liver
stiffness (LS) measured by Shear Wave Elastography (SWE) and anthropomorphic variables in
NAFLD patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility
to inclusion/exclusion 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 (e.g.,
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.
