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

New University of Lisbon

Status: Active, not recruiting

Conditions: Obesity; Type 2 Diabetes

Treatments: Dietary Supplement: Hafnia alvei HA4597™; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05170867

RESTART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women between 18 and 65 years
• BMI ≥35 kg/m2 and at least one severe obesity-related complications, or BMI ≥40 kg/m2
• Undergoing Roux-en-Y gastric bypass
• Willing to take a probiotic/placebo supplement twice a day for 60 days
• Willing and able to provide written informed

Exclusion criteria

• Intake of antibiotics and/or probiotics in the previous 12 weeks
• Weight change >5% in the previous 12 weeks
• Diagnosis of gastrointestinal disease or other significant illness
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Two capsules of Hafnia alvei HA4597™ probiotic/day (5 x 107 CFU/day) for 90 days

Treatment:

Dietary Supplement: Hafnia alvei HA4597™

Placebo group

Placebo Comparator group

Description:

Two identical capsules of placebo/day for 90 days

Treatment:

Other: Placebo