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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01356 | Registry Identifier | NCI CTRP |
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0 patient accrual
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The goal of this clinical research study is to learn if probiotics found in yogurt can help to decrease gastrointestinal (GI) symptoms in cancer patients. Probiotics are live bacteria and yeast that help with many of our functions and may help digestive problems. Researchers also want to learn if the bacteria in your stool change as your symptoms change while eating yogurt.
Baseline Tests:
If you agree to take part in this study, you will have the following tests and procedures when you enroll:
Study Procedures:
One (1) time during Days 3-7 and 1 time during Days 8-12:
You will be given at least 2 tablespoons (33 cc) of DannonÒ OikosÒyogurt each day.
Length of Study:
Your participation in this study will be over after you complete the study procedures during Days 8 to 12.
If you are discharged before you complete the study procedures above, you will be called and asked about your symptoms and given a stool collection kit. This phone call should take about 30 minutes to complete. The study staff will give you more information about stool collection. Your sample will be collected for bacteria testing at your next clinic visit.
This is an investigational study. The use of probiotics in yogurt to treat GI symptoms in cancer patients is investigational. The study doctor can explain how the probiotics are designed to work.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Antibiotics Taken During Past 2 Weeks | Experimental | Group 1: Participant was on antibiotics anytime during the past 2 weeks prior to the time of enrollment. Tongue assessment, stool sample, and questionnaires done at baseline and once during Days 3-7 and once during Days 8-12. Participants wear a Holter monitor for 20-24 hours at baseline and once during Days 3-7 and once during Days 8-12. Participants given 2 tablespoons (33 cc) of yogurt each day for 12 days. |
|
| Group 2 - No Antibiotics Taken During Past 2 Weeks | Experimental | Group 2: Participant has not been on antibiotics in the past 2 weeks. Tongue assessment, stool sample, and questionnaires done at baseline and once during Days 3-7 and once during Days 8-12. Participants wear a Holter monitor for 20-24 hours at baseline and once during Days 3-7 and once during Days 8-12. Participants given 2 tablespoons (33 cc) of yogurt each day for 12 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongue Assessment | Other | The coating on the top of the tongue assessed and categorized into three categories: no coating, thin coating and thick coating. The coating of the tongue may be related to the microorganisms in the intestine. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Bacteroidetes in Stool from Baseline to Day 12 | Baseline to Day 12 | |
| Percentage Change in Firmicutes in Stool from Baseline to Day 12 | Baseline to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence Rate of Dannon® Oikos® Yogurt Intake | Adherence rate calculated as percentage of times that a participant takes at least 2 table spoon (30 cc) of yogurt/day consumed for the 10±2 day prescription, as well as for the first 5±2 days, and will be summarized for each group using descriptive statistics. Regimen considered feasible for each group if at least 70% of participants in that group have reached at least 70% adherence rate in 10±2 days. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| An T. Ngo-Huang | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| D011795 | Surveys and Questionnaires |
| D015716 | Electrocardiography, Ambulatory |
| D015014 | Yogurt |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Stool Sample | Other | Stool sample collected at baseline and once during Days 3-7 and once during Days 8-12. |
|
| Questionnaires | Behavioral | Participants complete 4 questionnaires about symptoms in the past 24 hours, irritable bowel syndrome (IBS), most recent stool, and quality-of-life. Questionnaires completed at baseline and once during Days 3-7 and once during Days 8-12. Questionnaires should take about 30 minutes total to complete. |
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| Holter Monitor | Device | Participants wear a Holter monitor for 20-24 hours to check nervous system and heart function at baseline and once during Days 3-7 and once during Days 8-12. |
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| Yogurt | Other | Participants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days. |
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| 12 days |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |