Bariatric SurgeryGIBaNCT07286968
Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
An observational study of Bariatric Surgery and Roux-en Y Gastric Bypass, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery, Roux-en Y Gastric Bypass, Sleeve Gastrectomy
- What is being tested?
- Gastro-intestinal aspiration and Telemetric
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have previously undergone a RYGB surgery, SG surgery, or people with obesity.
Who may be able to join
- Participants eligible for inclusion in this Investigation have to meet all of the following criteria:
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Age: 18-65 years
- Specific inclusion criteria for the different patient populations:
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Patient is planned to undergo MRI procedure during usage of the wireless capsule
- 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
- Patient is pregnant, breastfeeding, actively trying to get pregnant or had recent childbirth in last 6 months
- 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.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bart Van der Schueren, Prof. Dr. contact
Netherlands1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen KU Leuven
Leuven, 3000
Maaike De Kreek, MSc, +32 16 34 72 89, maaike.dekreek@kuleuven.be
About this study
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.
Read the 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).
- Being tested
- Gastro-intestinal aspiration, Telemetric
- Keywords
- Gastro-intestinal aspiration, ingestible telemetric capsule
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastro-intestinal aspirationOther
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
TelemetricDevice
Telemetric ingestible capsule
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass | Patients who had undergone Roux-en-Y gastric bypass surgery Receives: Other: Gastro-intestinal aspiration; Device: Telemetric | |
| Sleeve gastrectomy | Patients who had undergone sleeve gastrectomy surgery Receives: Other: Gastro-intestinal aspiration; Device: Telemetric | |
| Patients living with obesity | Patients without previous bariatric surgery Receives: Other: Gastro-intestinal aspiration; Device: Telemetric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of gastric lipase
Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U)
Measured: 2 hours
Activity of pepsin
Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2 hours
Secondary outcomes (6)
Concentration of total bile acids
The total bile acid concentrations will be measured in all samples
Measured: 2 hours
pH
pH will be measured in all gastro-intestinal samples
Measured: 2 hours
Total transit time
Total transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Measured: 48 hours
Gastric emptying time
Gastric emptying time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Measured: 48 hours
Small intestinal transit time
Small intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Measured: 48 hours
Large intestinal transit time
Large intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286968
- Sponsor's protocol ID
- S70844
- Other IDs
- CIV-25-08-054154
- Acronym
- GIBa
- Status last verified
- Nov 2025
- First submitted
- 3 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07286968
- Acronym / sponsor ID
- GIBa / S70844
- Keywords
- Gastro-intestinal aspiration, ingestible telemetric capsule
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass | – | Other: Gastro-intestinal aspiration, Device: TelemetricPatients who had undergone Roux-en-Y gastric bypass surgery |
| Sleeve gastrectomy | – | Other: Gastro-intestinal aspiration, Device: TelemetricPatients who had undergone sleeve gastrectomy surgery |
| Patients living with obesity | – | Other: Gastro-intestinal aspiration, Device: TelemetricPatients without previous bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have previously undergone a RYGB surgery, SG surgery, or people with obesity.
Key inclusion criteria (8 listed)
- Participants eligible for inclusion in this Investigation have to meet all of the following criteria:
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Age: 18-65 years
- Body Mass Index: > 30 kg/m2
- Surgery: at least one year after Roux-en-Y gastric bypass or sleeve gastrectomy
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastro-intestinal aspirationAspiration of fluids from the stomach and small intestine using a naso-intestinal catheter. | Other | Patients living with obesity, Roux-en-Y gastric bypass, Sleeve gastrectomy |
| TelemetricTelemetric ingestible capsule | Device | Patients living with obesity, Roux-en-Y gastric bypass, Sleeve gastrectomy |
Primary outcome
Activity of gastric lipase
Time frame: 2 hours
Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U)
Activity of pepsin
Time frame: 2 hours
Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U)
Activity of trypsin
Time frame: 2 hours
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for trypsin activity (described in U).
Activity of chymotrypsin
Time frame: 2 hours
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for chymotrypsin activity (described in U).
Activity of α-amylase
Time frame: 2 hours
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for α-amylase activity (described in U).
Activity of pancreatic lipase
Time frame: 2 hours
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for pancreatic lipase activity (described in U).
6 secondary outcomes
Concentration of total bile acids
Time frame: 2 hours
pH
Time frame: 2 hours
Total transit time
Time frame: 48 hours
Gastric emptying time
Time frame: 48 hours
Small intestinal transit time
Time frame: 48 hours
Large intestinal transit time
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bart Van der Schueren, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Roux-en Y Gastric Bypass, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maaike De Kreek, MSc (+32 16 34 72 89, maaike.dekreek@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity of gastric lipase (time frame: 2 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.