PROBEProbiotics for Postoperative Symptoms and Gut Health After Sleeve Gastrectomy
This study aims to assess whether taking probiotics can help reduce constipation and improve gut health in individuals recovering from sleeve gastrectomy surgery.
Probiotic
+ Diet
Body Weight+7
+ Constipation
+ Nutrition Disorders
Prevention Study
Summary
Study start date: July 10, 2025
Actual date on which the first participant was enrolled.This study is designed to explore whether taking probiotics can enhance the quality of life for patients after sleeve gastrectomy by improving digestive health and the absorption of nutrients. It specifically targets individuals with a body mass index (BMI) of 40 kg/m² or higher, who are preparing to undergo this weight loss surgery. The research aims to determine if probiotics can help with symptoms like constipation, which can affect patients after surgery, and ultimately improve their recovery experience. Participants in this study will first provide a stool sample before surgery to analyze their gut bacteria. After the sleeve gastrectomy procedure, they will be randomly assigned to one of two groups; one group will take probiotics containing specific beneficial bacteria, while the other group will receive a placebo that has no active ingredients. Researchers will collect stool samples again at one and three months post-surgery to compare changes in gut bacteria between the two groups. The main focus is to see if probiotics can reduce constipation, with participants reporting whether they experience this issue in the weeks following surgery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Age over 18 years. 2. BMI over 40 kg/m² or over 35 kg/m² with obesity-related comorbidities. 3. Successful qualification for sleeve gastrectomy. 4. Informed consent to participate in the study. Exclusion Criteria: 1. Age under 18 years. 2. Chronic gastrointestinal diseases. 3. Use of antibiotic therapy within 4 weeks prior to surgery. 4. Lack of consent to participate in the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location