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

Obesity Clinical Trial

Official title:

The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05170867
• Other study ID #: RESTART
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes
• Weight Loss

Intervention

Dietary Supplement:
• Hafnia alvei HA4597™
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Portugal	NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Academia CUF

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).