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Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria

Marc R Yago, Adam R Frymoyer, Gillian S Smelick, Lynda A Frassetto, Nageshwar R Budha, Mark J Dresser, Joseph A Ware, Leslie Z Benet
Molecular pharmaceutics 2013 10(11):4032-4037

Bibliography

PubMed
PMID 23980906
PubMed Central
PMC3946491
Funding
Indexed grant support: T32 GM007175 — NIGMS NIH HHS — United States; UL1 RR024131 — NCRR NIH HHS — United States; UL1RR024131 — NCRR NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignOpen-label pharmacology pilot
ModelHuman participants
Sample6 healthy volunteers with induced low gastric acidity
InterventionBetaine HCl 1.5 g after rabeprazole
DurationSingle-dose pH monitoring for 2 hours
EndpointsGastric pH; Duration of reacidification

What the study showed, in plain terms

Published in 2013, this source examined betaine hcl and topical formulations. Design: Open-label pharmacology pilot. Sample/model: 6 healthy volunteers with induced low gastric acidity. The exposure or intervention was Betaine HCl 1.5 g after rabeprazole. Follow-up or treatment period: Single-dose pH monitoring for 2 hours.

Betaine HCl rapidly and temporarily lowered stomach pH under drug-induced hypochlorhydria.

An acidifying HCl formulation in an induced model; no symptom, nutrient-deficiency or anhydrous-TMG benefit was established.

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Key findings

  • Betaine HCl rapidly and temporarily lowered stomach pH under drug-induced hypochlorhydria.
  • The recorded outcome domains were Gastric pH; Duration of reacidification.
  • The result applies to the tested exposure: Betaine HCl 1.5 g after rabeprazole; Single-dose pH monitoring for 2 hours.

What this study can and cannot tell us

  • An acidifying HCl formulation in an induced model; no symptom, nutrient-deficiency or anhydrous-TMG benefit was established.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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