CompletedNot Applicable

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

Portugal49 participantsStarted 2022-01-14

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Excess weight loss

Timeframe: At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).

HbA1c

Trial details

NCT IDNCT05170867

SponsorUniversidade Nova de Lisboa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

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