Clinical trial for Obesity
Official title The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
ClinicalTrials.gov ID: NCT05320796
What this study is testing
- What it's testing
- This study is testing whether Esomeprazole tablets or a liquid form can change the acidity in the stomach pouch after gastric bypass. It also looks at how much of the medicine stays in the blood.
- Who it's for
- You may be able to join if you have had gastric bypass surgery and have stomach acid problems like reflux or ulcers.
- What's involved
- You will take either a 40mg Esomeprazole tablet or a 40mg liquid dose mixed with water. The study will measure your stomach acidity and blood levels of the medicine. You may need to give a blood sample and have your stomach pH checked.
- Time commitment
- The study lasts a few weeks, with a few visits for medication, blood draws, and stomach pH measurements.
- Phase 4: studies an already-approved treatment
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Proximal Roux-en-Y gastric bypass with linear stapled anastomosis 12 months prior to the study investigation
- Routine administration of proton pump inhibitors for 6 months postoperatively
- No intake of proton pump inhibitors at least 4 weeks prior to study investigation
- No marginal ulcers in upper endoscopy prior to placement of wireless BRAVO™ pH monitoring capsule
- No symptoms related to gastro-esophageal reflux or marginal ulcers (i.e. epigastric pain, retrosternal burning, regurgitation)
You likely can't join if
- Known intolerance or allergy for Esomeprazol
- Contraindication for upper endoscopy
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Women who are pregnant or breast feeding Major hepatic dysfunction
See the full eligibility criteria
- Proximal Roux-en-Y gastric bypass with linear stapled anastomosis 12 months prior to the study investigation
- Routine administration of proton pump inhibitors for 6 months postoperatively
- No intake of proton pump inhibitors at least 4 weeks prior to study investigation
- No marginal ulcers in upper endoscopy prior to placement of wireless BRAVO™ pH monitoring capsule
- No symptoms related to gastro-esophageal reflux or marginal ulcers (i.e. epigastric pain, retrosternal burning, regurgitation)
- Informed consent as documented by signature
- Known intolerance or allergy for Esomeprazol
- Contraindication for upper endoscopy
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Women who are pregnant or breast feeding Major hepatic dysfunction
The study team makes the final eligibility decision.
Where it is enrolling
- Schlieren, Schlieren, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Schlieren, Schlieren, Switzerland. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.