NCT07286968

Gastro-Intestinal Digestion and Physiology After Bariatric Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 51 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical trial aims to characterize gastric and pancreatic enzyme activity in adults aged 18 to 65 who have previously (at least 1 year ago) undergone Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG), as well as in individuals with obesity. In addition, the study seeks to quantify bile acid concentrations and pH at various locations within the gastrointestinal tract and to assess gastrointestinal transit time. During the study, aspirates will be collected from multiple regions of the gastrointestinal tract using a naso-intestinal catheter (study visit 1). An ingestible capsule will also be used to obtain continuous in vivo measurements of physiological conditions along the entire gastrointestinal tract (study visit 2).

Conditions

• Bariatric Surgery
• Roux-en Y Gastric Bypass
• Sleeve Gastrectomy
• Obesity & Overweight

Interventions

Type	Name	Description
OTHER	Gastro-intestinal aspiration	Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
DEVICE	Telemetric	Telemetric ingestible capsule

Timeline

• Start date: 2026-01-10
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-12-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: Netherlands