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Morbid ObesityNCT07461610

Stool Analysis After Sleeve Gastrectomy vs Gastric Bypass

An observational study of Morbid Obesity, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Morbid Obesity
What is being tested?
Laparoscopic Sleeve Gastrectomy, Mini Gastric Bypass and Roux-en-Y Gastric Bypass
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteEgypt
Study dates
5 Apr 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients with morbid obesity scheduled for primary bariatric surgery at Kasr Al-Ainy University Hospitals, Cairo, Egypt.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Eid Aziz, Lecturer contact

+201127060844

Ahmed-eid@kasralainy.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of Medicine Cairo University

    Cairo, Al-Manial Cairo, 11956

    Mahmoud El Azhary, Lecturer, +201064110221, Mahmoud.azhary@kasralainy.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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?

Read more

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

Read the 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)

Conditions
Morbid Obesity
Being tested
Laparoscopic Sleeve Gastrectomy, Mini Gastric Bypass, Roux-en-Y Gastric Bypass
Keywords
Bariatric Surgery, Stool Analysis, Fecal Calprotectin, Reducing Substances, Maldigestion, Gut Microbiota
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Sleeve GastrectomyProcedure or surgery

    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.

  • Mini Gastric BypassProcedure or surgery

    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.

  • Roux-en-Y Gastric BypassProcedure or surgery

    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.

Study groups in NCT07461610
Study groupRoleWhat they receive
Sleeve Gastrectomy (SG)Patients undergoing primary laparoscopic sleeve gastrectomy as treatment for morbid obesity. This group serves as the restrictive procedure comparator.
Receives: Procedure: Laparoscopic Sleeve Gastrectomy
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.
Receives: Procedure: Mini Gastric Bypass; Procedure: Roux-en-Y Gastric Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Stool pH

    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.

    Measured: At Baseline and at 6 months postoperatively

  2. Change in Fecal Calprotectin Level

    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.

    Measured: At Baseline and at 6 months postoperatively

  3. Presence of Undigested Food Particles

    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.

    Measured: At Baseline and at 6 months postoperatively

  4. Presence of Reducing Substances

    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.

    Measured: At Baseline and at 6 months postoperatively

  5. Change in Stool White Blood Cell Count

    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.

    Measured: At Baseline and at 6 months postoperatively

  6. Change in Stool Red Blood Cell Count

    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.

    Measured: At Baseline and at 6 months postoperatively

Secondary outcomes (18)
  1. Percentage Total Weight Loss (%TWL)

    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.

    Measured: 6 months postoperatively

  2. Diabetes Remission Rate

    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.

    Measured: 6 months postoperatively

  3. Change in Fasting Plasma Glucose

    Change in fasting plasma glucose (mg/dL) from preoperative baseline to 6 months after surgery

    Measured: At Baseline and at 6 months postoperatively

  4. Change in HbA1c

    Change in glycated hemoglobin (HbA1c %) from preoperative baseline to 6 months after surgery.

    Measured: At Baseline and at 6 months postoperatively

  5. Change in Lipid Profile

    Changes in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) from preoperative baseline to 6 months after surgery.

    Measured: At Baseline and at 6 months postoperatively

  6. Change in High-Sensitivity C-Reactive Protein (hs-CRP)

    Change in hs-CRP (mg/L) from preoperative baseline to 6 months after surgery as a marker of systemic inflammation.

    Measured: At Baseline and at 6 months postoperatively

  7. Correlation Between Stool Parameters and Clinical Outcomes

    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.

    Measured: 6 months postoperatively

  8. Prevalence of Elevated Fecal Calprotectin

    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.

    Measured: At Baseline and at 6 months postoperatively

  9. Prevalence of Positive Reducing Substances

    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.

    Measured: At Baseline and at 6 months postoperatively

  10. Prevalence of Mucus in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  11. Prevalence of Elevated White Blood Cells in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  12. Prevalence of Elevated Red Blood Cells in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  13. Prevalence of Trophozoites in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  14. Prevalence of Cysts in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  15. Prevalence of Ova in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  16. Prevalence of Larva in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  17. Prevalence of Flagellates in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

  18. Prevalence of Ciliates in Stool

    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.

    Measured: At Baseline and at 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start5 Apr 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07461610
Sponsor's protocol ID
Ms-48-2026
Status last verified
May 2026
First submitted
4 Mar 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Morbid Obesity, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Eid Aziz, Lecturer (+201127060844, Ahmed-eid@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Stool pH (time frame: At Baseline and at 6 months postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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