Clinical trial NCT03177681: The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms
Official title: The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malignant Neoplasms of Independent (Primary) Multiple Sites
Keywords: Malignant neoplasms of independent (primary) multiple sites
Gastrointestinal symptoms
Probiotics
Yogurt
Stool sample
Questionnaires
Surveys
Holter monitor
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Cancer patient
2. 18 years old or older
3. Has gastrointestinal symptoms with severity score of \</= 60 out of 100 visual analog scale for irritable bowel syndrome (VAS-IBS) in at least 2 out of 7 items measured
4. Able to eat by mouth
5. Estimated length of hospital stay is 10 days or more
6. Must give written study consent

Exclusion Criteria:

1. Neutropenic patient with absolute neutrophil count (ANC) less than 1000 cells/mm3
2. Patient within 100 days of auto /allo stem cell transplant and their stem cell physician does not approve yogurt ingestion.
3. Has intestinal obstruction.
4. Patient is currently on antibiotics
5. Allergic to yogurt
6. Patient who eats yogurt equal or more than once a day in the last 3 days.

Primary outcomes:
measure: Percentage Change in Bacteroidetes in Stool from Baseline to Day 12
timeFrame: Baseline to Day 12
measure: Percentage Change in Firmicutes in Stool from Baseline to Day 12
timeFrame: Baseline to Day 12
Secondary outcomes:
measure: Adherence Rate of Dannon® Oikos® Yogurt Intake
timeFrame: 12 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: An T. Ngo-Huang
role: PRINCIPAL_INVESTIGATOR
References: