Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Phase 1

Active, not recruiting

• Conditions: Hypochlorhydria
• Interventions: Drug: Omeprazole 20mg; Dietary Supplement: Vitamin C

• Registration Number: NCT04199624
• Lead Sponsor: Indiana University

Brief Summary

This study evaluates the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhydria. All participants will receive ascorbic acid tablets to measure the change in gastric pH.

Detailed Description

Elevation of gastric pH in patients with hypochlorhydria can reduce the solubility of weakly basic drugs. This may lead to poor and unpredictable systemic exposure for poorly soluble drugs. For example, extent of absorption of the kinase inhibitors, dasatinib (Sprycel) and erlotinib (Tarceva), is reduced by up to 61% and 46% respectively in patients on acid-reducing agents (ARAs). This pilot study is to evaluate the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhdyria. Using pH/impedance testing, we are seeking to determine the magnitude and duration of pH change upon administration of 1000 mg of ascorbic acid in healthy subjects with proton-pump inhibitor induced hypochlorhydria. The results from this study will be used to evaluate the use of ascorbic acid as a drug-drug interaction mitigation strategy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Study Start: 2021-10-01
• Primary Completion: 2024-01-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

• Healthy, young males age 18-30 years with no prior history of gastrointestinal disease or symptoms.

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Exclusion Criteria

• Hypochlorhydria (baseline use antacids, antisecretory medications, or surface agents including proton-pump inhibitors, H2 blockers, or sucralfate).
• Current or previous history of gastrointestinal disease including gastroesophageal reflux disease, Barrett's esophagus, peptic ulcer disease, dyspepsia, gastroparesis, bacterial overgrowth, microscopic colitis, gastric intestinal metaplasia or metaplastic atrophic gastritis, gastric neuroendocrine tumors, helicobacter pylori infection, inflammatory bowel disease (Crohn's disease or ulcerative colitis), celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease).
• History of gastric bypass or other abdominal surgeries excluding cholecystectomy or appendectomy > 6 months prior to study initiation.
• Radiation therapy to the abdomen.
• Pregnant females.
• Ingestion of any prescription, over-the-counter, or herbal medications which may affect study interpretation.
• Currently a smoker
• Antibiotic use within the last 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: omeprazole and ascorbic acid	Omeprazole 20mg	-
Experimental: omeprazole and ascorbic acid	Vitamin C	-

Primary Outcome Measures

Name	Time	Method
Change in gastric pH and duration of gastric pH \status	Five hours	Gastric pH measurements will be continuously monitored throughout the study using a catheter-based pH monitoring system. Gastric pH versus time data will be collected for five hours.

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States