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NCT05770076
Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)
NA trial testing Probiotic lysate (postbiotic and metabiotic) in Obesity in 55 participants. Completed in 31 December 2023.
31 December 2023
Quick facts
| Lead sponsor | Bogomolets National Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 February 2023 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 4 locations across Ukraine |
Drugs / interventions tested
- Probiotic lysate (postbiotic and metabiotic)
- Placebo
Conditions studied
- Obesity — all drugs for Obesity →
- Obesity, Abdominal — all drugs for Obesity, Abdominal →
- Insulin Resistance — all drugs for Insulin Resistance →
- Insulin Sensitivity — all drugs for Insulin Sensitivity →
Sponsor
Bogomolets National Medical University
Who can join
Adults 18 to 70, any sex, with Obesity or Obesity, Abdominal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Comprehensive Overview of Postbiotics with a Special Focus on Discovery Techniques and Clinical Applications.
Kumar A, Green KM, Rawat M. · · 2024 · cited 34× · PMID 39335866 · DOI 10.3390/foods13182937 -
Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study).
Savytska M, Baka O, Manzhalii E, Kyriienko D, et al · · 2026 · PMID 42158917 · DOI 10.3389/fendo.2026.1802045 -
Incorporating Postbiotics into Intervention for Managing Obesity.
Hijová E, Bertková I, Štofilová J. · · 2025 · PMID 40508171 · DOI 10.3390/ijms26115362
Verify or expand the search:
- PubMed search for NCT05770076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Bogomolets National Medical University trials
Trials by the same sponsor.
- NCT07249814 — Comparison of Fractionated Versus Bolus Administration of Different Doses of Hyperbaric Bupivacaine Combined With Opioid · NA · completed
- NCT06857331 — Perioperative Analgesia With Erector Spinae Plane Block in Liver Transplant Recipients · NA · recruiting
- NCT05804422 — Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD Study) · NA · completed
- NCT06352697 — Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study) · NA · completed
- NCT06619977 — ANI-Guided Fentanyl Infusion During Living Donor Liver Resections · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05770076 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bogomolets National Medical University
- Last refreshed: 3 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05770076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing