NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon, 1169-056, Portugal
NCT Number: NCT05170867
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lisbon, 1169-056, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Changes in percentage of excess weight loss from baseline.
Time frame: 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).
Changes in HbA1c levels (%) from baseline.
Time frame: 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).
Changes in gut microbiota from baseline. Bacterial DNA will be extracted from faecal samples. 16S rRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
Time frame: 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).
Changes in gastrointestinal quality of life by the Gastrointestinal Quality of Life Index (GIQLI) questionnaire from baseline. The GIQLI is a 36 -item questionnaire and consists of 5 different subscales. The total score is calculated as the sum of the 36 items each ranged from 0 to 4. The final score range from 0 to 144 points (lower scores indicate more unfavorable conditions).
Time frame: 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).
Changes in caseinolytic protease B (pM) from baseline.
Time frame: 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).
Changes in short-chain fatty acids (acetate, propionate and butyrate) concentrations (mg/mL) from baseline. Short-chain fatty acids will be measured by targeted metabolomics.
Time frame: 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).
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Time frame: 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).
Changes in insulin levels (μU/mL) levels from baseline.
Time frame: 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).
Changes in c-peptide levels (ng/mL) levels from baseline.
Time frame: 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).
Changes in total cholesterol levels (mg/dL) from baseline.
Time frame: 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).
Changes in high-density lipoprotein (HDL) cholesterol (mg/dL) levels from baseline.
Time frame: 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).
Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
Time frame: 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).
Changes in triacylglycerides (mg/dL) levels from baseline.
Time frame: 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).
Changes in percentage of body fat mass from baseline.
Time frame: 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).
Changes in free fat mass (kg) from baseline.
Time frame: At visit 1 (Baseline), visit 5 (12 months after bariatric surgery).
Percentage of subjects losing >50% of baseline excess weight from baseline to visit 5 (12 months after bariatric surgery).
Universidade Nova de Lisboa
Other
The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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