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NCT05170867
The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery
NA trial testing Hafnia alvei HA4597™ in Obesity in 49 participants. Participants enrolled and being followed up; not accepting new ones.
31 May 2025
Quick facts
| Lead sponsor | Universidade Nova de Lisboa |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 14 January 2022 |
| Primary completion | 31 May 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Portugal |
Drugs / interventions tested
- Hafnia alvei HA4597™
- Placebo
Conditions studied
- Obesity — all drugs for Obesity →
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Universidade Nova de Lisboa — full company profile →
Who can join
Adults 18 to 65, any sex, with Obesity or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y gastric bypass will receive probiotics or placebo, twice a day, for 90 days, one month after surgery. Outcomes will be measured at baseline, and 3, 6, 9 and 12 months after the surgery.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Role of Next-Generation Probiotics in Obesity and Obesity-Associated Disorders: Current Knowledge and Future Perspectives.
Vallianou NG, Kounatidis D, Tsilingiris D, Panagopoulos F, et al · · 2023 · cited 73× · PMID 37047729 · DOI 10.3390/ijms24076755 -
Exploring Therapeutic Advances: A Comprehensive Review of Intestinal Microbiota Modulators.
Pires L, González-Paramás AM, Heleno SA, Calhelha RC. · · 2024 · cited 13× · PMID 39200020 · DOI 10.3390/antibiotics13080720 -
The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery - study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial.
Ismael S, Vaz C, Durão C, Silvestre MP, et al · · 2023 · cited 2× · PMID 37248499 · DOI 10.1186/s13063-023-07383-0
Verify or expand the search:
- PubMed search for NCT05170867
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universidade Nova de Lisboa trials
Trials by the same sponsor.
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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 NCT05170867 (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 Universidade Nova de Lisboa
- Last refreshed: 9 May 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/NCT05170867.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing