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

Primary Purpose

Obesity, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Hafnia alvei HA4597™
Placebo
Sponsored by
Universidade Nova de Lisboa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Gut microbiota, Probiotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de LisboaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

Two capsules of Hafnia alvei HA4597™ probiotic/day (5 x 107 CFU/day) for 60 days

Two identical capsules of placebo/day for 60 days

Outcomes

Primary Outcome Measures

Excess weight loss
Changes in percentage of excess weight loss from baseline.
HbA1c
Changes in HbA1c levels (%) from baseline.

Secondary Outcome Measures

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.
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).
Caseinolytic protease B
Changes in caseinolytic protease B (pM) from baseline.
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.
Fasting blood glucose
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Insulin
Changes in insulin levels (μU/mL) levels from baseline.
C-peptide
Changes in c-peptide levels (ng/mL) levels from baseline.
Total cholesterol
Changes in total cholesterol levels (mg/dL) from baseline.
HDL cholesterol
Changes in high-density lipoprotein (HDL) cholesterol (mg/dL) levels from baseline.
LDL cholesterol
Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
Triacylglycerides
Changes in triacylglycerides (mg/dL) levels from baseline.
Body fat mass
Changes in percentage of body fat mass from baseline.
Free fat mass
Changes in free fat mass (kg) from baseline.
Proportion of subjects losing more than 50% of baseline excess weight
Percentage of subjects losing >50% of baseline excess weight from baseline to visit 6 (12 months after bariatric surgery).

Full Information

First Posted
December 10, 2021
Last Updated
November 2, 2022
Sponsor
Universidade Nova de Lisboa
Collaborators
Academia CUF
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1. Study Identification

Unique Protocol Identification Number
NCT05170867
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Nova de Lisboa
Collaborators
Academia CUF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 60 days, one month after surgery. Outcomes will be measured at baseline, and 1, 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 60 days, one month after surgery. Outcomes will be measured at baseline, and 1, 3, 6, 9 and 12 months after the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Obesity, Gut microbiota, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
Two capsules of Hafnia alvei HA4597™ probiotic/day (5 x 107 CFU/day) for 60 days
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Two identical capsules of placebo/day for 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Hafnia alvei HA4597™
Intervention Description
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 60 days. Two capsules of the dietary supplement contain 5x107 CFU of Hafnia alvei HA4597™, 5 mg of zinc and 20 μg of chromium.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
One capsule of placebo, twice a day, to be taken with water, during each breakfast and lunch (approx. 5 minutes after starting eating), for 60 days. Two capsules of the placebo contain 5 mg of zinc and 20 μg of chromium.
Primary Outcome Measure Information:
Title
Excess weight loss
Description
Changes in percentage of excess weight loss from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
HbA1c
Description
Changes in HbA1c levels (%) from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Secondary Outcome Measure Information:
Title
Gut microbiota
Description
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 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Gastrointestinal quality of life
Description
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 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Caseinolytic protease B
Description
Changes in caseinolytic protease B (pM) from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Gut microbiota metabolites
Description
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 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Fasting blood glucose
Description
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Insulin
Description
Changes in insulin levels (μU/mL) levels from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
C-peptide
Description
Changes in c-peptide levels (ng/mL) levels from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Total cholesterol
Description
Changes in total cholesterol levels (mg/dL) from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
HDL cholesterol
Description
Changes in high-density lipoprotein (HDL) cholesterol (mg/dL) levels from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
LDL cholesterol
Description
Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Triacylglycerides
Description
Changes in triacylglycerides (mg/dL) levels from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Body fat mass
Description
Changes in percentage of body fat mass from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Free fat mass
Description
Changes in free fat mass (kg) from baseline.
Time Frame
At visit 1 (Baseline), visit 2 (1 month after bariatric surgery), visit 3 (3 months after bariatric surgery), visit 4 (6 months after bariatric surgery), visit 5 (9 months after bariatric surgery), visit 6 (12 months after bariatric surgery).
Title
Proportion of subjects losing more than 50% of baseline excess weight
Description
Percentage of subjects losing >50% of baseline excess weight from baseline to visit 6 (12 months after bariatric surgery).
Time Frame
At visit 1 (Baseline), visit 6 (12 months after bariatric surgery).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cláudia Marques
Phone
+351218803000
Email
claudia.sofia.marques@nms.unl.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Teixeira
Phone
+351218803000
Email
diana.teixeira@nms.unl.pt
Facility Information:
Facility Name
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
City
Lisboa
ZIP/Postal Code
1169-056
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cláudia Marques, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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