Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04199624

Collaborator

Hala Fadda (Other), Butler University (Other)

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypochlorhydria	Drug: Omeprazole 20mg Dietary Supplement: Vitamin C	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: omeprazole and ascorbic acid	Drug: Omeprazole 20mg Omeprazole twice daily x 5 days Dietary Supplement: Vitamin C Ascorbic acid x 1 on day 5

Arm

Intervention/Treatment

Experimental: Experimental: omeprazole and ascorbic acid

Drug: Omeprazole 20mg

Omeprazole twice daily x 5 days

Dietary Supplement: Vitamin C

Ascorbic acid x 1 on day 5

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University
Hala Fadda
Butler University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Shin, Assistant Professor, Indiana University

ClinicalTrials.gov Identifier:

NCT04199624

Other Study ID Numbers:

1911069261

First Posted:

Dec 16, 2019

Last Update Posted:

Apr 6, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Achlorhydria

Ascorbic Acid

Omeprazole

Study Results

No Results Posted as of Apr 6, 2022