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Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Primary Purpose

Hypochlorhydria

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Omeprazole 20mg

Vitamin C

About this trial

This is an interventional treatment trial for Hypochlorhydria

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Indiana University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: omeprazole and ascorbic acid

Arm Description

Outcomes

Primary Outcome Measures

Change in gastric pH and duration of gastric pH \status

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04199624

First Posted

December 12, 2019

Last Updated

February 20, 2023

Sponsor

Indiana University

Collaborators

Hala Fadda, Butler University

1. Study Identification

Unique Protocol Identification Number

NCT04199624

Brief Title

Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Official Title

Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Hala Fadda, Butler University

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypochlorhydria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: omeprazole and ascorbic acid

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Omeprazole 20mg

Intervention Description

Omeprazole twice daily x 5 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin C

Intervention Description

Ascorbic acid x 1 on day 5

Primary Outcome Measure Information:

Title

Change in gastric pH and duration of gastric pH \status

Description

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.

Time Frame

Five hours

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Biological males

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alka Kadariya

Phone

317-278-9296

akadariy@iu.edu

Facility Information:

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alka Kadariya

akadariy@iu.edu

Phone

317-278-9296

12. IPD Sharing Statement

Plan to Share IPD

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Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

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