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| Name | Class |
|---|---|
| Hala Fadda | UNKNOWN |
| Butler University | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: omeprazole and ascorbic acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole 20mg | Drug | Omeprazole twice daily x 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal microbiome profile, intestinal metabolomic profile | To explore the correlation between physiologic responses in gastric pH with features of the intestinal microbiome and microbial metabolites (e.g. metabolome). | From time of initial stool drop-off to thirteen months after that time point. |
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Inclusion Criteria:
Exclusion Criteria:
Biological males
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D000126 | Achlorhydria |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000137 | Acid-Base Imbalance |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Vitamin C |
| Dietary Supplement |
Ascorbic acid x 1 on day 5 |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |