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NCT05170867

The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery

Active, enrolled NA Last updated 9 May 2024
What this trial tests

NA trial testing Hafnia alvei HA4597™ in Obesity in 49 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
14 January 2022
Primary endpoint
31 May 2025
31 December 2025

Quick facts

Lead sponsorUniversidade Nova de Lisboa
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment49
Start date14 January 2022
Primary completion31 May 2025
Estimated completion31 December 2025
Sites1 location across Portugal

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Universidade Nova de Lisboa trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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