Clinical trial NCT04199624: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Hypochlorhydria
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Hala Fadda
name: Butler University
First posted: 2019-12-16
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in gastric pH and duration of gastric pH \status
timeFrame: Five hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: