Stool Analysis After Sleeve Gastrectomy vs Gastric Bypass
Recruiting · NCT07461610 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cairo University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this observational study is to learn whether routine stool tests can detect changes in gut function 6 months after two common types of weight loss surgery: sleeve gastrectomy and gastric bypass (including mini gastric bypass and Roux-en-Y gastric bypass). The main questions it aims to answer are: Do stool tests show more signs of undigested food or carbohydrate malabsorption after gastric bypass compared to sleeve gastrectomy? Do signs of gut inflammation in stool (like fecal calprotectin) decrease after surgery, and does this relate to improvements in blood sugar and weight loss? Can simple stool test results at 6 months predict how much weight a person loses or how well their diabetes improves? Researchers will compare stool test results between the two surgery groups (sleeve gastrectomy vs. gastric bypass) to see if the type of surgery leads to different changes in gut health. Participants will: Provide a stool sample before surgery and again 6 months after surgery Provide a blood sample at the same time points to measure weight, blood sugar, and cholesterol Undergo their planned weight loss surgery as part of their regular medical care
Who can take part
Inclusion criteria
- Male and female patients aged 18 to 60 years
- Body Mass Index (BMI) ≥ 40 kg/m², OR BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (type 2 diabetes, hypertension, dyslipidemia, osteoarthritis, obstructive sleep apnea)
- Patients scheduled for primary laparoscopic bariatric surgery (either SG or Gastric Bypass \[MGB or RYGB\]) at Kasr Al-Ainy University Hospitals
- Provision of written informed consent
Exclusion criteria
- Age \< 18 years or \> 60 years
- Previous bariatric surgery or major gastrointestinal surgery (gastric, intestinal, or colorectal resection)
- Chronic kidney disease (eGFR \< 60 mL/min/1.73m²) or previous renal transplant
- Chronic liver disease (cirrhosis, chronic hepatitis) or liver failure
- Chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, or chronic pancreatitis
- Active malignancy or history of chemotherapy/radiotherapy in the past 5 years
- Pregnancy or breastfeeding
- Chronic alcohol abuse or substance abuse
- Use of antibiotics, probiotics, or prebiotics within 4 weeks prior to stool sample collection (to avoid confounding effects on gut flora)
- Acute gastrointestinal infection at the time of sample collection
Where it is running
1 location listed.
- Faculty of Medicine Cairo University - Cairo, Al-Manial Cairo, Egypt