CompletedPhase 4

Esomeprazole and Gastric Emptying of Beer

Germany16 participantsStarted 2006-01

Plain-language summary

To investigate the effect of 20 mg esomeprazole daily for one week on gastric emptying of 500 ml beer, the consecutive blood alcohol levels, the gastroesophageal reflux and plasma levels of gastrin and CCK in a randomized, placebo-controlled, double-blinded manner in 16 healthy male volunteers. Hypothesis: The combined taking of esomeprazole and beer will inhibit gastric emptying as compared to the intake of beer alone. This will induce a delay of the ethanol absorption and of the consecutive blood ethanol concentrations. Gastric acid secretion after beer will be reduced after esomeprazole treatment. Therefore, gastroesophageal acid reflux will be reduced after the combined taking. We speculate that gastrin, but not CCK plasma levels, will be increased after the combined taking as compared to beer alone. Both, beer and PPIs, have stimulatory effects on gastrin release. However, the secretion of CCK from duodenal CCK-cells is inhibited when gastric emptying is prolonged.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male, non-smoking volunteers without regular medication or regular alcohol consumption will be included. * Before inclusion blood will be drawn and the following blood count, liver, pancreas, kidney, thyroid and coagulation parameters will be examined: * Creatinine (0.5 - 1.3 mg/dl), * Alc. Phosphatase (38 - 126 U/l), * GGT (0 - 85 U/l), * ALAT (0 - 50 U/l), * ASAT (0 - 37 U/l), * LDH (0 - 248 U/l), * Cholinesterase (\>7000 U/l), * Amylase (25 - 130 U/l), * Lipase (114 - 300 U/l), * Leucocytes (3,5 - 11.0 10E9/L), * Erythrocytes (4.0 - 5.9 10E12/L), * Hb (12.0 - 17.5 g/dl), * Ht (33 - 50%), * Platelets (145 - 440 10E9/L), * CrP (\< 10 mg/l), * TSH (0.4 - 5.0 mE/l), * fT4 (6 - 23 pmol/l), * INR (0.75 - 1.30), * PTT (15.0 - 33.0 sec.) The results have to be within the physiological range (as given in parenthesis). Moreover, volunteers have mentally to be able to understand the explanations concerning the study and follow to the instructions of the investigator. Exclusion Criteria: * Any acute or chronic disease, * Heartburn more than once weekly, * Alcohol consumption of more than 50 g ethanol-equivalent per week, * Smoking, * Known hypersensitivity against esomeprazole, * Benzimidazole or other ingredients of the medication, * Fructose-intolerance, * Glucose-galactose-malabsorption or saccharase-isomaltase-deficiency.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastric emptying time, gastroesophageal reflux

Timeframe: 3h

Trial details

NCT IDNCT00472550

SponsorHeidelberg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Gastroesophageal Reflux trials