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Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.
All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.
The intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.
Elucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole and VSL #3 | Active Comparator | Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics |
|
| Placebo and VSL #3 | Placebo Comparator | Participants will receive placebo and VSL #3 Probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | Proton pump inhibitor (PPI) that suppresses gastric acid secretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4. | Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Symptoms Related to VSL#3 Treatment. | Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days. | Week 0 through Week 4 |
| Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aida Habtezion, M.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35063245 | Derived | Singh G, Haileselassie Y, Briscoe L, Bai L, Patel A, Sanjines E, Hendler S, Singh PK, Garud NR, Limketkai BN, Habtezion A. The effect of gastric acid suppression on probiotic colonization in a double blinded randomized clinical trial. Clin Nutr ESPEN. 2022 Feb;47:70-77. doi: 10.1016/j.clnesp.2021.11.005. Epub 2021 Nov 10. |
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Participants attended an initial study visit at week -2, followed by a baseline visit at week 0, and a final visit at week 4.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omeprazole and VSL #3 | Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics |
| FG001 | Placebo and VSL #3 | Placebo and VSL #3 Probiotics |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were collected at visit 2 (week 0). Participants who attended visit 2 are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omeprazole and VSL #3 | Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics |
| BG001 | Placebo and VSL #3 | Placebo and VSL #3 Probiotics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4. | Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed. | Participants who attended the week 4 visit are included in the analysis. | Posted | Mean | Standard Deviation | percentage of abundance | Week 4 |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omeprazole and VSL #3 | Proton pump inhibitor (Omeprazole) and VSL #3 Probiotics |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aida Habtezion | Stanford University | 650-736-5555 | aidah@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2018 | Dec 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2019 | Dec 13, 2019 | SAP_001.pdf |
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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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| VSL #3 | Dietary Supplement | Probiotics |
|
| Placebo | Drug | Placebo to match omeprazole |
|
From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed. |
| Week 0 and Week 4 |
| Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3). | From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed. MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only. | Week 0 and Week 4 |
| Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group). | From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed. MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only. | Week 0 and Week 4 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Relative Abundance of Probiotic Strains | Relative abundance is reported as the percent of combined probiotic strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus). | Mean | Standard Deviation | percentage of abundance |
|
| Number of participants experiencing gastro-intestinal symptoms. | Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days. | Count of Participants | Participants |
|
| Placebo and VSL #3 |
Placebo and VSL #3 Probiotics |
|
|
|
| Secondary | Number of Participants With Symptoms Related to VSL#3 Treatment. | Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days. | Participants who attended the week 4 visit are included in the analysis. | Posted | Count of Participants | Participants | Week 0 through Week 4 |
|
|
|
| Secondary | Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration | From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed. | Participants who attended the week 4 visit are included in the analysis. | Posted | Mean | Standard Deviation | percentage of abundance | Week 0 and Week 4 |
|
|
|
| Secondary | Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3). | From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed. MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only. | Participants in the Omeprazole and VSL#3 group who attended the week 4 visit are included in the analysis. | Posted | Mean | Standard Deviation | MZ/RT | Week 0 and Week 4 |
|
|
|
| Secondary | Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group). | From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed. MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only. | Participants in the Placebo and VSL#3 group who attended the week 4 visit are included in the analysis. | Posted | Mean | Standard Deviation | MZ/RT | Week 0 and Week 4 |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 7 |
| 19 |
| EG001 | Placebo and VSL #3 | Placebo and VSL #3 Probiotics | 0 | 20 | 0 | 20 | 9 | 20 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Increased stool frequency | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Diarrhea |
|
| Firmicutes at Week 0 |
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| Firmicutes at Week 4 |
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| Proteobacteria at Week 0 |
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| Proteobacteria at Week 4 |
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| Actinobacteria at Week 0 |
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| Actinobacteria at Week 4 |
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| FA(14:0) at Week 4 |
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| Iloprost S-isomer at Week 0 |
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| Iloprost S-isomer at Week 4 |
|