NCT05770076Completed
Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)
Effect of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation on Metabolic Parameters in Type 2 Diabetes Patients
Source: ClinicalTrials.gov · Last updated 3 Apr 2024
Brief summary (registry, in English)
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 3 Mar 2023
- Start date
- 1 Feb 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Bogomolets National Medical University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05770076
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 1 Feb 2023 to the primary completion date, 31 Dec 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, SGLT-2 antagonists, GLP-1 analogues, DPP IV inhibitors etc);
- regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) within 3 months prior to enrollment;
- participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment;
Other illness
- presence of type 1 diabetes;
- severe diabetes-related complications at screening (ie, end-stage DKD, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
- allergy on probiotics or their components;
- presence of gastrointestinal diseases such as food allergy, celiac disease, non-specific ulcerative colitis;
- uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;
Other
- participation in other clinical trials;
- presence of pregnancy or lactation.
Who the study is looking for
- adult participants (ages 18-70)
- presence of T2D diagnosed according to criteria of the American Diabetes Association;
- BMI 25-40 kg/m2;
- patient who treated with diet and exercise alone or metformin, SUs and insulin on a stabilized dose for at least 3 months before the study;
- daily insulin dosage less than 60IU;
- HbA1c between 6.5 and 10.0 %;
- written informed consent.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Kyiv City Clinical Endocrinology Center Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Bogomolets National Medical University Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Danylo Halytsky Lviv National Medical University Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
Related publications
- Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study).Front Endocrinol (Lausanne) · 2026 · PMID 42158917
This page is information, not medical advice. Discuss any trial with your doctor.