Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2023
CompletedSeptember 22, 2025
September 1, 2025
1.7 years
December 12, 2019
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From time of inpatient appointment to thirteen months after that time point.
Secondary Outcomes (1)
Intestinal microbiome profile, intestinal metabolomic profile
From time of initial stool drop-off to thirteen months after that time point.
Study Arms (1)
Experimental: omeprazole and ascorbic acid
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy, young males age 18-30 years with no prior history of gastrointestinal disease or symptoms.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Hala Faddacollaborator
- Butler Universitycollaborator
Study Sites (1)
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
October 1, 2021
Primary Completion
June 7, 2023
Study Completion
June 7, 2023
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share