Clinical trial NCT05170867: The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery
Official title: The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Gut microbiota
Probiotics
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Academia CUF
First posted: 2021-12-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
measure: HbA1c
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).
Secondary outcomes:
measure: Gut microbiota
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).
measure: Gastrointestinal quality of life
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).
measure: Caseinolytic protease B
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).
measure: Gut microbiota metabolites
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).
measure: Fasting blood glucose
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).
measure: Insulin
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).
measure: C-peptide
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).
measure: Total cholesterol
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).
measure: HDL cholesterol
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).
measure: LDL cholesterol
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).
measure: Triacylglycerides
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).
measure: Body fat mass
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).
measure: Free fat mass
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).
measure: Proportion of subjects losing more than 50% of baseline excess weight
timeFrame: At visit 1 (Baseline), visit 5 (12 months after bariatric surgery).
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Study officials:
References: