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

NCT05170867 | Completed

• 1 other identifier: RESTART
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Type 2 Diabetes

Keywords

Obesity; Gut microbiota; Probiotics

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (14)

• Gut microbiota

  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).

• Gastrointestinal quality of life

  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

  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

  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

  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).

Study Arms (2)

Probiotic group

EXPERIMENTAL

Two capsules of Hafnia alvei HA4597™ probiotic/day (5 x 107 CFU/day) for 90 days

Dietary Supplement: Hafnia alvei HA4597™

Placebo group

PLACEBO COMPARATOR

Two identical capsules of placebo/day for 90 days

Other: Placebo

Interventions

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.

Probiotic group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Academia CUF: collaborator

Study Sites (1)

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

Lisbon, 1169-056, Portugal

Location

Related Publications (1)

• 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.

  PMID: 37248499 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 28, 2021
• Study Start: January 14, 2022
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

PT (1)