Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
NCT ID: NCT07286968
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
51 participants
OBSERVATIONAL
2026-01-10
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Roux-en-Y gastric bypass
Patients who had undergone Roux-en-Y gastric bypass surgery
Gastro-intestinal aspiration
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
Telemetric
Telemetric ingestible capsule
Sleeve gastrectomy
Patients who had undergone sleeve gastrectomy surgery
Gastro-intestinal aspiration
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
Telemetric
Telemetric ingestible capsule
Patients living with obesity
Patients without previous bariatric surgery
Gastro-intestinal aspiration
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
Telemetric
Telemetric ingestible capsule
Interventions
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Gastro-intestinal aspiration
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
Telemetric
Telemetric ingestible capsule
Eligibility Criteria
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Inclusion Criteria
1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. Age: 18-65 years
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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Universitaire Ziekenhuizen KU Leuven
Leuven, , Netherlands
Countries
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Central Contacts
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Bart Van der Schueren, Prof. Dr.
Role: CONTACT
Facility Contacts
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Maaike De Kreek, MSc
Role: primary
Other Identifiers
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CIV-25-08-054154
Identifier Type: OTHER
Identifier Source: secondary_id
S70844
Identifier Type: -
Identifier Source: org_study_id