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Completed

NCT Number: NCT05170867

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Lisbon, 1169-056, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Excess weight loss

    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.

  2. HbA1c

    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.

Secondary outcomes

  1. Gut microbiota

    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.

  2. Gastrointestinal quality of life

    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).

  3. Caseinolytic protease B

    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.

  4. Gut microbiota metabolites

    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.

  5. Fasting blood glucose

    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.

  6. Insulin

    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.

  7. C-peptide

    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.

  8. Total cholesterol

    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.

  9. HDL cholesterol

    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.

  10. LDL cholesterol

    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.

  11. Triacylglycerides

    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.

  12. Body fat mass

    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.

  13. Free fat mass

    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.

  14. Proportion of subjects losing more than 50% of baseline excess weight

    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).

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • Academia CUF

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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