Malignant Neoplasms of Independent (Primary) Multiple SitesNCT03177681
The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms
A study testing Tongue Assessment, Stool Sample and Questionnaires in people with Malignant Neoplasms of Independent (Primary) Multiple Sites, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Independent (Primary) Multiple Sites
- What is being tested?
- Tongue Assessment, Stool Sample and Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patient
- 18 years old or older
- 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
- Able to eat by mouth
- Estimated length of hospital stay is 10 days or more
- Must give written study consent
Who cannot join
- Neutropenic patient with absolute neutrophil count (ANC) less than 1000 cells/mm3
- Patient within 100 days of auto /allo stem cell transplant and their stem cell physician does not approve yogurt ingestion.
- Has intestinal obstruction.
- Patient is currently on antibiotics
- Allergic to yogurt
- Patient who eats yogurt equal or more than once a day in the last 3 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Being tested
- Tongue Assessment, Stool Sample, Questionnaires, Holter Monitor, Yogurt
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Gastrointestinal symptoms, Probiotics, Yogurt, Stool sample, Questionnaires, Surveys, Holter monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue AssessmentOther
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.
Stool SampleOther
Stool sample collected at baseline and once during Days 3-7 and once during Days 8-12.
QuestionnairesBehavioural
Also called Surveys
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.
Holter MonitorDevice
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.
YogurtOther
Participants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tongue Assessment; Other: Stool Sample; Behavioral: Questionnaires; Device: Holter Monitor; Other: Yogurt |
| 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. Receives: Other: Tongue Assessment; Other: Stool Sample; Behavioral: Questionnaires; Device: Holter Monitor; Other: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Bacteroidetes in Stool from Baseline to Day 12
Measured: Baseline to Day 12
Percentage Change in Firmicutes in Stool from Baseline to Day 12
Measured: Baseline to Day 12
Secondary outcomes (1)
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.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Mar 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Why it stopped: 0 patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Independent (Primary) Multiple SitesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- An T. Ngo-Huang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177681
- Sponsor's protocol ID
- 2017-0052
- Other IDs
- NCI-2018-01356
- Status last verified
- Mar 2023
- First submitted
- 2 Jun 2017
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms
- ClinicalTrials.gov ID
- NCT03177681
- Acronym / sponsor ID
- 2017-0052
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Gastrointestinal symptoms, Probiotics, Yogurt, Stool sample, Questionnaires, Surveys, Holter monitor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Antibiotics Taken During Past 2 Weeks | Experimental | Other: Tongue Assessment, Other: Stool Sample, Behavioral: Questionnaires, Device: Holter Monitor, Other: YogurtGroup 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 | Other: Tongue Assessment, Other: Stool Sample, Behavioral: Questionnaires, Device: Holter Monitor, Other: YogurtGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cancer patient
- 18 years old or older
- 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
- Able to eat by mouth
- Estimated length of hospital stay is 10 days or more
Key exclusion criteria (6 listed)
- Neutropenic patient with absolute neutrophil count (ANC) less than 1000 cells/mm3
- Patient within 100 days of auto /allo stem cell transplant and their stem cell physician does not approve yogurt ingestion.
- Has intestinal obstruction.
- Patient is currently on antibiotics
- Allergic to yogurt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue AssessmentThe 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 | Group 1 - Antibiotics Taken During Past 2 Weeks, Group 2 - No Antibiotics Taken During Past 2 Weeks |
| Stool SampleStool sample collected at baseline and once during Days 3-7 and once during Days 8-12. | Other | Group 1 - Antibiotics Taken During Past 2 Weeks, Group 2 - No Antibiotics Taken During Past 2 Weeks |
| QuestionnairesAlso: SurveysParticipants 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. | Behavioural | Group 1 - Antibiotics Taken During Past 2 Weeks, Group 2 - No Antibiotics Taken During Past 2 Weeks |
| Holter MonitorParticipants 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. | Device | Group 1 - Antibiotics Taken During Past 2 Weeks, Group 2 - No Antibiotics Taken During Past 2 Weeks |
| YogurtParticipants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days. | Other | Group 1 - Antibiotics Taken During Past 2 Weeks, Group 2 - No Antibiotics Taken During Past 2 Weeks |
Primary outcome
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
1 secondary outcome
Adherence Rate of Dannon® Oikos® Yogurt Intake
Time frame: 12 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An T. Ngo-Huang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue Assessment, Stool Sample and Questionnaires in people with Malignant Neoplasms of Independent (Primary) Multiple Sites, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Bacteroidetes in Stool from Baseline to Day 12 (time frame: Baseline to Day 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.