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

This study is not yet open for participant recruitment.
Verified September 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177681
First Posted: June 6, 2017
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Malignant Neoplasms of Independent (Primary) Multiple Sites Other: Tongue Assessment Other: Stool Sample Behavioral: Questionnaires Device: Holter Monitor Other: Yogurt

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Percentage Change in Bacteroidetes in Stool from Baseline to Day 12 [ Time Frame: Baseline to Day 12 ]
  • Percentage Change in Firmicutes in Stool from Baseline to Day 12 [ Time Frame: Baseline to Day 12 ]

Secondary Outcome Measures:
  • Adherence Rate of Dannon® Oikos® Yogurt Intake [ Time Frame: 12 days ]
    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.


Estimated Enrollment: 40
Anticipated Study Start Date: February 2018
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 - Antibiotics Taken During Past 2 Weeks

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.

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.
Other Name: Surveys
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.
Experimental: Group 2 - No Antibiotics Taken During Past 2 Weeks

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.

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.
Other Name: Surveys
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177681


Contacts
Contact: Ying Guo, MD, MS 713-792-6085 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ying Guo, MD, MS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03177681     History of Changes
Other Study ID Numbers: 2017-0052
First Submitted: June 2, 2017
First Posted: June 6, 2017
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of independent (primary) multiple sites
Gastrointestinal symptoms
Probiotics
Yogurt
Stool sample
Questionnaires
Surveys
Holter monitor

Additional relevant MeSH terms:
Neoplasms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents