- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461610
Stool Analysis After Sleeve Gastrectomy vs Gastric Bypass
Routine Stool Parameters Six Months After Sleeve Gastrectomy vs. Gastric Bypass: Correlation With Weight Loss and Metabolic Outcomes
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Fasting plasma glucose (mg/dL)
- Glycated hemoglobin (HbA1c %)
- Lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mg/dL)
- High-sensitivity C-reactive protein (hs-CRP) (mg/L) as a marker of systemic inflammation
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)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Eid Aziz, Lecturer
- Phone Number: +201127060844
- Email: Ahmed-eid@kasralainy.edu.eg
Study Locations
-
-
Al-Manial Cairo
-
Cairo, Al-Manial Cairo, Egypt, 11956
- Recruiting
- Faculty of medicine Cairo University
-
Contact:
- Mahmoud El Azhary, Lecturer
- Phone Number: +201064110221
- Email: Mahmoud.azhary@kasralainy.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sleeve Gastrectomy (SG)
Patients undergoing primary laparoscopic sleeve gastrectomy as treatment for morbid obesity.
This group serves as the restrictive procedure comparator.
|
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.
|
|
Gastric Bypass (MGB/RYGB)
Patients undergoing primary laparoscopic gastric bypass, including both Mini Gastric Bypass (MGB) and Roux-en-Y Gastric Bypass (RYGB), as treatment for morbid obesity.
This group serves as the diversionary procedure comparator.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stool pH
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.
|
At Baseline and at 6 months postoperatively
|
|
Change in Fecal Calprotectin Level
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.
|
At Baseline and at 6 months postoperatively
|
|
Presence of Undigested Food Particles
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.
|
At Baseline and at 6 months postoperatively
|
|
Presence of Reducing Substances
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.
|
At Baseline and at 6 months postoperatively
|
|
Change in Stool White Blood Cell Count
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.
|
At Baseline and at 6 months postoperatively
|
|
Change in Stool Red Blood Cell Count
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.
|
At Baseline and at 6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage Total Weight Loss (%TWL)
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.
|
6 months postoperatively
|
|
Diabetes Remission Rate
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.
|
6 months postoperatively
|
|
Change in Fasting Plasma Glucose
Time Frame: At Baseline and at 6 months postoperatively
|
Change in fasting plasma glucose (mg/dL) from preoperative baseline to 6 months after surgery
|
At Baseline and at 6 months postoperatively
|
|
Change in HbA1c
Time Frame: At Baseline and at 6 months postoperatively
|
Change in glycated hemoglobin (HbA1c %) from preoperative baseline to 6 months after surgery.
|
At Baseline and at 6 months postoperatively
|
|
Change in Lipid Profile
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.
|
At Baseline and at 6 months postoperatively
|
|
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
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.
|
At Baseline and at 6 months postoperatively
|
|
Correlation Between Stool Parameters and Clinical Outcomes
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.
|
6 months postoperatively
|
|
Prevalence of Elevated Fecal Calprotectin
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Positive Reducing Substances
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Mucus in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Elevated White Blood Cells in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Elevated Red Blood Cells in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Trophozoites in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Cysts in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Ova in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Larva in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Flagellates in Stool
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.
|
At Baseline and at 6 months postoperatively
|
|
Prevalence of Ciliates in Stool
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.
|
At Baseline and at 6 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Obesity
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity, Morbid
- Therapeutics
- Surgical Procedures, Operative
- Digestive System Surgical Procedures
- Anastomosis, Surgical
- Bariatric Surgery
- Bariatrics
- Obesity Management
- Gastroenterostomy
- Gastric Bypass
Other Study ID Numbers
- Ms-48-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Morbid Obesity
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Sohag UniversityActive, not recruitingMorbid Obesity Requiring Bariatric SurgeryEgypt
-
General Committee of Teaching Hospitals and Institutes...CompletedMorbid Obesity Requiring Bariatric SurgeryEgypt
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Yongtao SunThe First Hospital affiliated of Shandong First Medical UniversityNot yet recruiting
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Laval UniversityInstitut universitaire de cardiologie et de pneumologie de Québec, University...Recruiting
-
Husson UniversityCompletedMorbid Obesity
Clinical Trials on Laparoscopic Sleeve Gastrectomy
-
King Saud UniversityNew You Medical CenterCompleted
-
Ankara UniversityCompletedObesity & OverweightTurkey (Türkiye)
-
Mohammad DaboosCompletedPediatric Obesity | Morbid Obesity | LAP
-
Umraniye Education and Research HospitalCompletedPostoperative Complications | Bleeding | Postoperative Nausea and VomitingTurkey
-
Sengkang General HospitalSingapore General HospitalRecruitingObesity | Gastroesophageal Reflux | Bariatric Surgery Candidate | Esophagus InjurySingapore
-
University of FoggiaCompletedBleeding | Obesity, Morbid | Bariatric Surgery Candidate | Leak, AnastomoticItaly
-
Sercan YUKSEL, MDCompletedMorbid Obesity Requiring Bariatric SurgeryTurkey (Türkiye)
-
Sercan YUKSEL, MDCompletedMorbid Obesity Requiring Bariatric SurgeryTurkey (Türkiye)
-
Yigit DUZKOYLUActive, not recruitingMorbid Obesity Requiring Bariatric SurgeryTurkey (Türkiye)
-
Centre Hospitalier Universitaire, AmiensCompleted