The Impact of Probiotics on Bariatric Treatment Outcomes

NCT07258732 | Active Not Recruiting

• 1 other identifier: 1/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The planned study aims to assess whether probiotics improve the quality of life in patients during the early postoperative period following sleeve gastrectomy, and whether they influence the absorption of micro- and macronutrients. Patients eligible for inclusion will have a BMI of 40 kg/m² or higher and must have successfully completed the qualification process for sleeve gastrectomy. Exclusion criteria include chronic gastrointestinal diseases, antibiotic use within 4 weeks prior to surgery, and lack of consent to participate in the study. On the day before surgery, a stool sample will be collected from each patient for microbiological analysis to assess the composition of gut bacteria. Patients will then undergo sleeve gastrectomy using a standard surgical technique. After the operation, participants will be randomized into two groups. The first group will receive probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14. These strains are deposited in the Polish Collection of Microorganisms at the Polish Academy of Sciences in Wrocław and are protected by Polish, European, and U.S. patents. The second group will receive a placebo. As part of follow-up, stool samples will be collected again one month and three months after surgery for comparative microbiological analysis.

Conditions

Obesity &Amp; Overweight

Keywords

obesity; sleeve gastrectomy; constipation

Outcome Measures

Primary Outcomes (1)

• Assessment of the impact of probiotics on the resolution of constipation after sleeve gastrectomy

  The primary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked whether constipation occurred (yes or no).

  one and three months after surgery

Secondary Outcomes (9)

• Assessment of the impact of probiotics on gastrointestinal symptoms after SG

  one and three months after surgery

• Assessment of the impact of probiotics on gastrointestinal symptoms after SG

  one and three months after surgery

• Assessment of the impact of probiotics on gastrointestinal symptoms after SG

  one and three months after surgery

• Metabolic changes after the probiotics use in patients after SG

  one and three months after surgery

• Metabolic changes after the probiotics use in patients after SG

  one and three months after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Diet

Control

ACTIVE COMPARATOR

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14.

Control

Diet OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Age over 18 years.
• BMI over 40 kg/m² or over 35 kg/m² with obesity-related comorbidities.
• Successful qualification for sleeve gastrectomy.
• Informed consent to participate in the study.

You may not qualify if:

• Age under 18 years.
• Chronic gastrointestinal diseases.
• Use of antibiotic therapy within 4 weeks prior to surgery.
• Lack of consent to participate in the study.

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead

Study Sites (1)

University of Warmia and Mazury

Olsztyn, 10-015, Poland

Location

MeSH Terms

Conditions

Obesity; Overweight; Constipation

Interventions

Probiotics; Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: December 2, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)