NCT05170867

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

The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Gut microbiota dysbiosis is associated with the pathophysiology of obesity. Bariatric surgery is an effective treatment for obesity that induces changes in the gut microbiota. However, recent studies indicate that the gut microbiota is not fully restored after bariatric surgery which may limit the potential of the surgery to achieve metabolic control and maintain weight loss. Thus, modulating the gut microbiota with probiotics after bariatric surgery could be an effective strategy to improve the success of the surgery. 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.

Conditions

• Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hafnia alvei HA4597™	One capsule of probiotic supplement, twice a day, to be taken with water, during each breakfast and lunch (approx. 5 minutes after starting eating), for 90 days. Two capsules of the dietary supplement contain 5x107 CFU of Hafnia alvei HA4597™, 5 mg of zinc and 20 μg of chromium.
OTHER	Placebo	One capsule of placebo, twice a day, to be taken with water, during each breakfast and lunch (approx. 5 minutes after starting eating), for 90 days. Two capsules of the placebo contain 5 mg of zinc and 20 μg of chromium.

Timeline

• Start date: 2022-01-14
• Primary completion: 2025-05-31
• Completion: 2025-12-31
• First posted: 2021-12-28
• Last updated: 2024-05-09

Locations

1 site across 1 country: Portugal