Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial

Area of Science:

• Gastroenterology
• Pharmacology
• Clinical Medicine

Background:

• Food intake transiently increases gastric pH.
• Understanding gastric pH regulation is crucial for drug efficacy and safety.
• Betaine hydrochloride (BHCl) is used to increase gastric acidity.

Purpose of the Study:

• To investigate the effect of food on gastric pH.
• To assess the efficacy of betaine hydrochloride (BHCl) in reacidifying gastric pH after food intake.
• To determine the optimal BHCl dosage for counteracting food-induced pH elevation.

Main Methods:

• Open-label, cross-over clinical study with 9 subjects.
• Randomized assignment to 16 possible 4-period cross-over sequences.
• Administration of 1500 mg, 3000 mg, and 4500 mg doses of BHCl after food ingestion.

Main Results:

• Food increased gastric pH, with a 49.7 ± 14.0 min return to baseline without supplementation.
• A 4500 mg dose of BHCl reacidified gastric pH to baseline in approximately 17.3 ± 5.9 min.
• Mean maximum pH after food ingestion was 3.20 ± 0.55.

Conclusions:

• Food significantly elevates and sustains gastric pH, even with acid supplementation.
• A 4500 mg BHCl dose is necessary to counteract food-induced gastric pH increase.
• Dosing BHCl is challenging due to its properties and interactions with food and acid-reducing agents.