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Clinical Trials in the Netherlands / NCT07286968
Recruiting Observational

Gastro-Intestinal Digestion and Physiology After Bariatric Surgery

NCT07286968 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2026-01-10
Last updated
2026-01-20

Condition(s) studied

Bariatric SurgeryRoux-en Y Gastric BypassSleeve GastrectomyObesity & Overweight

Investigational drug(s) / intervention(s)

Gastro-intestinal aspirationTelemetric

Gastro-intestinal aspiration: Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.

Telemetric: Telemetric ingestible capsule

Study summary

The goal of this clinical trial is to characterize gastrointestinal digestion and physiology in patients after bariatric surgery, or people living with obesity. The main question it aims to answer is: what is the status of gastrointestinal digestion and physiology after bariatric surgery? Participants will have two study visits: 1) participants will undergo collection of gastrointestinal samples and 2) participants will ingest an ingestible capsule that measures multiple physiological parameters along the gastrointestinal tract.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: Participants eligible for inclusion in this Investigation have to meet all of the following criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. Age: 18-65 years Specific inclusion criteria for the different patient populations: Patients with obesity: 3. Body Mass Index: \> 30 kg/m2 Patients after bariatric surgery: 4. Surgery: at least one year after Roux-en-Y gastric bypass or sleeve gastrectomy Exclusion Criteria: Participants eligible for this Investigation must not meet any of the following criteria: 1. Patient has history of more than one bariatric surgery 2. Patient has a waist circumference \> 125.6 cm 3. Patient had gastrointestinal surgery in the past three months 4. Patient has a pacemaker, defibrillator, infusion pump, or other portable or implanted electromedical device 5. Patient had frequent exposure to X-rays in the past year 6. Patient has swallowing disorders, among others: dysphagia for food or pills, any oropharyngeal or oesophageal stricture, anxiety or functional abnormality 7. Patient has Crohn's disease or Diverticulitis 8. Patient has gastrointestinal strictures, fistulas or physiological/mechanical obstructions 9. Patient has gastric bezoar 10. Patient has a history of complex bowel resection or known abdominal adhesions 11. Patient has short bowel syndrome or ostomy 12. Patient has currently ongoing infections 13. Patient is planned to undergo usage of rectal foam/enema or treatment with adjuvant chemotherapy or radiotherapy 14. Patient is currently on parenteral diet 15. Patient is planned to undergo MRI procedure during usage of the wireless capsule 16. Patient is working in a professional healthcare facility (e.g. hospital, dental office, emergency room), military area (e.g. submarine, near radar installation), or heavy industrial area (e.g. power plants, automotive, mining, refineries) during the duration of the clinical investigation 17. Patient is pregnant, breastfeeding, actively trying to get pregnant or had recent childbirth in last 6 months 18. Patient cannot discontinue medication that affects gastrointestinal transit time and/or pH for at least 3 days before and during the study (and 4 weeks for weekly/long-acting GLP-1 analogues such as Saxenda, Ozempic, Wegovy, Mounjaro). This includes opioids (e.g., morphine, codeine), proton pump inhibitors (e.g., omeprazole, esomeprazole, pantoprazole), H2-receptor antagonists (e.g., cimetidine, famotidine), antacids, sucralfate, prokinetics (e.g., domperidone, metoclopramide), antidiarrheal agents (e.g., loperamide), antibiotics, probiotics and prebiotics. 19. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universitaire Ziekenhuizen KU Leuven Leuven Netherlands Recruiting

More Universitaire Ziekenhuizen KU Leuven trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286968 on ClinicalTrials.gov ↗ ← All trials in the Netherlands