NCT03177681

The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Baseline Tests: If you agree to take part in this study, you will have the following tests and procedures when you enroll: * The coating on your tongue will be checked. Researchers think that the thickness of the coating on your tongue may be related to the microorganisms in your stomach and/or intestines. * A stool sample will be collected for bacteria testing. * You will be asked about your diet and how often you eat yogurt. * You will wear a monitoring device called a Holter monitor for 20-24 hours to check your nervous system and heart function. * You will be asked to complete 4 questionnaires about your symptoms in the past 24 hours, your irritable bowel syndrome (IBS), your most recent stool, and your quality-of-life. These questionnaires should take about 30 minutes total to complete. Study Procedures: One (1) time during Days 3-7 and 1 time during Days 8-12: * You will be asked to complete the same 4 questionnaires you completed at baseline. * A stool sample will be collected by your bedside nurse for bacteria testing. * You may wear a Holter monitor to check your heart function. 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.

Conditions

• Malignant Neoplasms of Independent (Primary) Multiple Sites

Interventions

Type	Name	Description
OTHER	Tongue Assessment	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.
OTHER	Stool Sample	Stool sample collected at baseline and once during Days 3-7 and once during Days 8-12.
BEHAVIORAL	Questionnaires	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.
DEVICE	Holter Monitor	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.
OTHER	Yogurt	Participants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-21
• Completion: 2023-03-21
• First posted: 2017-06-06
• Last updated: 2023-03-27

Locations

1 site across 1 country: United States