Gastro-Intestinal Digestion and Physiology After Bariatric Surgery

NCT07286968 | Recruiting

• 2 other identifiers: S70844CIV-25-08-054154
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Gastro-intestinal aspiration; ingestible telemetric capsule

Outcome Measures

Primary Outcomes (6)

• Activity of gastric lipase

  Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U)

  2 hours

• Activity of pepsin

  Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U)

  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).

  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).

  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).

  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).

  2 hours

Secondary Outcomes (6)

• Concentration of total bile acids

  2 hours

• pH

  2 hours

• Total transit time

  48 hours

• Gastric emptying time

  48 hours

• Small intestinal transit time

  48 hours

Study Arms (3)

Roux-en-Y gastric bypass

Patients who had undergone Roux-en-Y gastric bypass surgery

Other: Gastro-intestinal aspiration; Device: Telemetric

Sleeve gastrectomy

Patients who had undergone sleeve gastrectomy surgery

Other: Gastro-intestinal aspiration; Device: Telemetric

Patients living with obesity

Patients without previous bariatric surgery

Other: Gastro-intestinal aspiration; Device: Telemetric

Interventions

Gastro-intestinal aspiration OTHER

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

Patients living with obesity; Roux-en-Y gastric bypass; Sleeve gastrectomy

Telemetric DEVICE

Telemetric ingestible capsule

Patients living with obesity; Roux-en-Y gastric bypass; Sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have previously undergone a RYGB surgery, SG surgery, or people with obesity.

You may qualify if:

• Voluntary written informed consent of the participant has been obtained prior to any screening procedures
• Age: 18-65 years
• Patients with obesity:
• Body Mass Index: \> 30 kg/m2
• Patients after bariatric surgery:
• Surgery: at least one year after Roux-en-Y gastric bypass or sleeve gastrectomy

You may not qualify if:

• Participants eligible for this Investigation must not meet any of the following criteria:
• Patient has history of more than one bariatric surgery
• Patient has a waist circumference \> 125.6 cm
• Patient had gastrointestinal surgery in the past three months
• Patient has a pacemaker, defibrillator, infusion pump, or other portable or implanted electromedical device
• Patient had frequent exposure to X-rays in the past year
• Patient has swallowing disorders, among others: dysphagia for food or pills, any oropharyngeal or oesophageal stricture, anxiety or functional abnormality
• Patient has Crohn's disease or Diverticulitis
• Patient has gastrointestinal strictures, fistulas or physiological/mechanical obstructions
• Patient has gastric bezoar
• Patient has a history of complex bowel resection or known abdominal adhesions
• Patient has short bowel syndrome or ostomy
• Patient has currently ongoing infections
• Patient is planned to undergo usage of rectal foam/enema or treatment with adjuvant chemotherapy or radiotherapy
• Patient is currently on parenteral diet

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, 3000, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maaike De Kreek, MSc

CONTACT

+32 16 34 72 89; maaike.dekreek@kuleuven.be

Bart Van der Schueren, Prof. Dr.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-11

Locations

NL (1)