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The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus rhamnosus GG Group | Experimental | Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal. |
|
| Placebo Group | Placebo Comparator | Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 40 MG oral capsules daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Observed Operational Taxonomic Unit (OTU) diversity. | Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample. | Baseline, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants to report adverse events. | 60 days |
| Changes in Shannon diversity index. | Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandria Ramirez | Contact | 4805741853 | ramirez.alexandria@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| John DiBaise, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trial Website | View source |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lactobacillus rhamnosus GG | Dietary Supplement | Given as Culturelle Digestive Probiotic in the form of oral capsules daily |
|
| Placebo | Drug | Oral capsules daily that look exactly like the study drug, but contains to active ingredient |
|
| Baseline, Day 56 |
| Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways. | Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups. | Baseline, Day 56 |
| Changes in taxa units. | Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups. | Baseline, Day 56 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |