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| Name | Class |
|---|---|
| Academia CUF | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Two capsules of Hafnia alvei HA4597™ probiotic/day (5 x 107 CFU/day) for 90 days |
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| Placebo group | Placebo Comparator | Two identical capsules of placebo/day for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hafnia alvei HA4597™ | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Excess weight loss | Changes in percentage of excess weight loss from baseline. | 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 | Changes in HbA1c levels (%) from baseline. | 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 | Description | Time Frame |
|---|---|---|
| Gut microbiota | 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa | Lisbon | 1169-056 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37248499 | Derived | Ismael S, Vaz C, Durao C, Silvestre MP, Calhau C, Teixeira D, Marques C. The impact of Hafnia alvei HA4597 on weight loss and glycaemic control after bariatric surgery - study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial. Trials. 2023 May 29;24(1):362. doi: 10.1186/s13063-023-07383-0. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | 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. |
|
| Gastrointestinal quality of life | 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). | 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). |
| Caseinolytic protease B | Changes in caseinolytic protease B (pM) from baseline. | 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). |
| Gut microbiota metabolites | 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. | 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). |
| Fasting blood glucose | Changes in fasting blood glucose levels (mg/dL) levels from baseline. | 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). |
| Insulin | Changes in insulin levels (μU/mL) levels from baseline. | 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). |
| C-peptide | Changes in c-peptide levels (ng/mL) levels from baseline. | 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). |
| Total cholesterol | Changes in total cholesterol levels (mg/dL) from baseline. | 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). |
| HDL cholesterol | Changes in high-density lipoprotein (HDL) cholesterol (mg/dL) levels from baseline. | 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). |
| LDL cholesterol | Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline. | 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). |
| Triacylglycerides | Changes in triacylglycerides (mg/dL) levels from baseline. | 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). |
| Body fat mass | Changes in percentage of body fat mass from baseline. | 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). |
| Free fat mass | Changes in free fat mass (kg) from baseline. | 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). |
| Proportion of subjects losing more than 50% of baseline excess weight | Percentage of subjects losing >50% of baseline excess weight from baseline to visit 5 (12 months after bariatric surgery). | At visit 1 (Baseline), visit 5 (12 months after bariatric surgery). |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |