Esomeprazole and Gastric Emptying of Beer

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Heidelberg University
• Treatments: Esomeprazole

Criteria

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.