Actively Recruiting
Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-01-20
51
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating digestive enzyme activity and gastrointestinal physiology in adults aged 18 to 65 who have either undergone bariatric surgery at least one year ago or are living with obesity. The study aims to understand how digestion and gastrointestinal conditions differ after Roux-en-Y gastric bypass or sleeve gastrectomy surgeries compared to individuals with obesity without prior surgery. It focuses on measuring enzyme activity and bile acid concentrations throughout the digestive tract to better characterize digestive function in these groups. The study involves two main visits. During the first visit, fluids will be collected from multiple areas of the gastrointestinal tract using a naso-intestinal catheter to analyze enzyme activity and bile acids. In the second visit, participants will swallow a telemetric ingestible capsule that continuously measures various physiological parameters such as pH and transit times along the entire gastrointestinal tract. These procedures help researchers assess digestion and gastrointestinal transit in real time. Participants will be evaluated through sample collection and capsule monitoring to measure enzymes including gastric lipase, pepsin, trypsin, chymotrypsin, alpha-amylase, and pancreatic lipase. The study will also assess bile acid concentration, pH, and transit times in different gut regions over periods of 2 to 48 hours. Data collected will provide insights into digestive enzyme activity and gastrointestinal function after bariatric surgery or in obesity. The total study duration includes two visits with physiological assessments and monitoring of digestive processes.
CONDITIONS
Brief Title
Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- Age between 18 and 65 years
- For patients with obesity: Body Mass Index greater than 30 kg/m2
- For patients after bariatric surgery: Surgery occurred at least one year ago (Roux-en-Y gastric bypass or sleeve gastrectomy)
You will not qualify if you...
- History of more than one bariatric surgery
- Waist circumference greater than 125.6 cm
- Gastrointestinal surgery within the past three months
- Presence of pacemaker, defibrillator, infusion pump, or other implanted electromedical devices
- Frequent exposure to X-rays in the past year
- Swallowing disorders including dysphagia, strictures, or functional abnormalities
- Diagnosis of Crohn's disease or diverticulitis
- Gastrointestinal strictures, fistulas, or mechanical obstructions
- Presence of gastric bezoar
- History of complex bowel resection or known abdominal adhesions
- Short bowel syndrome or ostomy
- Ongoing infections
- Planned use of rectal foam/enema or adjuvant chemotherapy or radiotherapy
- Current parenteral diet
- Planned MRI during use of wireless capsule
- Employment in healthcare, military, or heavy industrial areas during study
- Pregnancy, breastfeeding, trying to conceive, or recent childbirth within 6 months
- Inability to stop medications affecting gastrointestinal transit or pH before and during study
- Any condition that may jeopardize safety or compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours for aspiration and capsule ingestion, with continuous measurements over 48 hours
Participants undergo aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter and swallow an ingestible capsule to obtain continuous in vivo measurements of physiological conditions along the gastrointestinal tract.
2 visits (in-person)
Duration - 48 hours
Participants are observed to assess gastrointestinal transit times and physiological conditions over 48 hours following the diagnostic procedures.
Continuous monitoring through the ingestible capsule
Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen KU Leuven
Leuven, Netherlands, 3000
Actively Recruiting
Research Team
M
Maaike De Kreek, MSc
B
Bart Van der Schueren, Prof. Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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