Faculty of Medicine Cairo University
Cairo, Al-Manial Cairo, 11956, Egypt
Location status: Recruiting
NCT Number: NCT07461610
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
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Cairo, Al-Manial Cairo, 11956, Egypt
Location status: Recruiting
Background:
Obesity is a global pandemic with rising incidence, contributing significantly to morbidity, mortality, and healthcare costs worldwide. Bariatric surgery, particularly sleeve gastrectomy (SG) and gastric bypass procedures (including Mini Gastric Bypass [MGB] and Roux-en-Y Gastric Bypass [RYGB]), remains the most effective and durable treatment for morbid obesity, achieving sustained weight loss and remission of metabolic comorbidities such as type 2 diabetes.
The gastrointestinal tract, particularly the gut microbiome, has emerged as a key metabolic regulator. Obesity is associated with dysbiosis-reduced microbial diversity and altered predominance of bacterial phyla-which contributes to systemic inflammation, insulin resistance, and metabolic syndrome. Bariatric surgery induces profound and durable changes in the gut environment, including alterations in gastric emptying, intestinal transit time, bile acid signaling, and the composition of the gut microbiota.
However, advanced microbiome sequencing is expensive, time-consuming, and not readily available in many clinical settings. Routine stool analysis, by contrast, is a simple, inexpensive, and universally available test that can provide valuable preliminary data on gut health. Parameters such as stool pH, the presence of leukocytes, undigested food particles, and quantitative markers like fecal calprotectin and reducing substances can offer indirect evidence of maldigestion, mucosal inflammation, and microbial activity.
Objective:
The primary objective is to compare changes in routine stool parameters (physical examination, microscopic examination, undigested food particles, fecal calprotectin, and reducing substances) from baseline to 6 months postoperatively between patients undergoing SG and those undergoing Gastric Bypass (MGB or RYGB).
Secondary objectives include: correlating postoperative changes in stool parameters with clinical outcomes (%TWL, diabetes remission, changes in HbA1c and lipid profile); comparing the prevalence of specific stool findings between groups; evaluating whether baseline stool parameters can predict postoperative outcomes; and assessing the utility of routine stool analysis as a simple, low-cost tool for monitoring gut health after bariatric surgery.
Methods:
This is a prospective, two-arm, observational cohort study conducted at the Department of General Surgery, Kasr Al-Ainy University Hospitals, Cairo, Egypt. The study period is from March 2026 to December 2026.
Study Timeline and Data Collection:
Patients will be assessed at two predefined time points:
T0 (Baseline): 1-2 weeks preoperatively - informed consent, demographic data, medical history, anthropometric measurements, blood samples, stool sample
T1 (6 months): 6 months ± 2 weeks postoperatively - anthropometric measurements, blood samples, stool sample, assessment of comorbidities, final outcomes
Clinical and Anthropometric Measurements:
Body weight (kg) and height (m) for BMI calculation (kg/m²)
Percentage total weight loss (%TWL) at 6 months = [(initial weight - 6-month weight) / initial weight] × 100
Presence and status of comorbidities (diabetes, hypertension, dyslipidemia)
Diabetes remission defined as HbA1c < 6.5% off all antidiabetic medications at 6 months
A total of 46 patients with morbid obesity (BMI ≥40 or ≥35 kg/m² with comorbidities) scheduled for primary laparoscopic bariatric surgery will be enrolled and allocated into two groups: Group A (SG, n=23) and Group B (Gastric Bypass [MGB or RYGB], n=23). The type of gastric bypass (MGB vs. RYGB) will be determined by the surgical team based on patient anatomy, comorbidities, and surgeon preference, reflecting real-world clinical practice.
Blood Sampling and Biochemical Analysis:
After an overnight fast (8-12 hours), venous blood will be collected at both time points for:
Stool Sample Collection and Analysis:
Patients will be provided with a sterile, leak-proof stool collection container and written instructions. They will collect a fresh morning stool sample at home. Samples should be transported to the hospital laboratory within 2 hours of collection. If immediate transport is not possible, samples should be refrigerated (4°C) and transported within 12 hours.
Stool analysis parameters include:
Physical Examination: Color, consistency, odor, mucus, pH
Microscopic Examination: White Blood Cells (WBCs), Red Blood Cells (RBCs), trophozoites, cysts, ova, larva, flagellates, ciliate
Undigested Food Particles: Meat fibers, vegetable particles, starch granules, fat globules
Quantitative Tests: Fecal calprotectin (ELISA), Reducing substances (Clinitest tablets)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic sleeve gastrectomy performed using a standard technique with a 36-Fr bougie, transecting the stomach starting 4-6 cm from the pylorus, excising the entire greater curvature and fundus. The staple line is inspected for hemostasis and leakage.
Laparoscopic mini gastric bypass performed using a standard technique with a long gastric tube created from the angle of His to the antrum, and a loop gastrojejunostomy with a biliopancreatic limb of 200 cm.
Laparoscopic Roux-en-Y gastric bypass performed using a standard antecolic, antegastric technique. A small 30-mL gastric pouch is created. The biliopancreatic limb is 70-150 cm, and the alimentary (Roux) limb is 100-150 cm. Jejunojejunostomy is performed to restore continuity.
Time frame: At Baseline and at 6 months postoperatively
Change in stool pH measured by pH indicator strip from preoperative baseline to 6 months after surgery. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Change in fecal calprotectin concentration (μg/g) measured by ELISA from preoperative baseline to 6 months after surgery. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Presence or absence of undigested meat fibers and vegetable particles on microscopic examination at 6 months after surgery. Comparison of prevalence between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Presence or absence of reducing substances (indicating carbohydrate malabsorption) measured by Clinitest tablets at 6 months after surgery. Comparison of prevalence between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Change in white blood cell count (cells per high-power field) on microscopic examination from preoperative baseline to 6 months after surgery. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Change in red blood cell count (cells per high-power field) on microscopic examination from preoperative baseline to 6 months after surgery. Presence of RBCs may indicate mucosal irritation at staple lines or altered barrier function. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: 6 months postoperatively
Percentage total weight loss calculated as [(initial weight - 6-month weight) / initial weight] × 100. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: 6 months postoperatively
Proportion of patients with type 2 diabetes at baseline who achieve remission, defined as HbA1c < 6.5% off all antidiabetic medications at 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Change in fasting plasma glucose (mg/dL) from preoperative baseline to 6 months after surgery
Time frame: At Baseline and at 6 months postoperatively
Change in glycated hemoglobin (HbA1c %) from preoperative baseline to 6 months after surgery.
Time frame: At Baseline and at 6 months postoperatively
Changes in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) from preoperative baseline to 6 months after surgery.
Time frame: At Baseline and at 6 months postoperatively
Change in hs-CRP (mg/L) from preoperative baseline to 6 months after surgery as a marker of systemic inflammation.
Time frame: 6 months postoperatively
Correlation between changes in stool parameters (WBC count, RBC count, pH, fecal calprotectin, reducing substances, undigested food particles, mucus, trophozoites, cysts, ova, larva, flagellates, ciliates) and clinical outcomes (%TWL, change in HbA1c) using Spearman's rank correlation coefficient.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of elevated fecal calprotectin (>50 μg/g) in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of positive reducing substances (indicating carbohydrate malabsorption) in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of visible mucus on physical examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of elevated white blood cells (>10 per high-power field) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of elevated red blood cells (>5 per high-power field) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of trophozoites (any) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of cysts (any) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of ova (any) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of larva (any) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of flagellates (e.g., Giardia) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Time frame: At Baseline and at 6 months postoperatively
Prevalence of ciliates (e.g., Balantidium coli) on microscopic examination in each group at baseline and 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Routine Stool Parameters Six Months After Sleeve Gastrectomy vs. Gastric Bypass: Correlation With Weight Loss and Metabolic Outcomes
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