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.
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).
Study Type
OBSERVATIONAL
Enrollment
51
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
Telemetric ingestible capsule
Universitaire Ziekenhuizen KU Leuven
Leuven, Netherlands
RECRUITINGActivity of gastric lipase
Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U)
Time frame: 2 hours
Activity of pepsin
Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U)
Time frame: 2 hours
Activity of trypsin
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for trypsin activity (described in U).
Time frame: 2 hours
Activity of chymotrypsin
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for chymotrypsin activity (described in U).
Time frame: 2 hours
Activity of α-amylase
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for α-amylase activity (described in U).
Time frame: 2 hours
Activity of pancreatic lipase
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for pancreatic lipase activity (described in U).
Time frame: 2 hours
Concentration of total bile acids
The total bile acid concentrations will be measured in all samples
Time frame: 2 hours
pH
pH will be measured in all gastro-intestinal samples
Time frame: 2 hours
Total transit time
Total transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Time frame: 48 hours
Gastric emptying time
Gastric emptying time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Time frame: 48 hours
Small intestinal transit time
Small intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Time frame: 48 hours
Large intestinal transit time
Large intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Time frame: 48 hours
Bart Van der Schueren, Prof. Dr.
CONTACT
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