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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Mar 2022

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

June 2, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed

4.7 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed

Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

June 2, 2017

Last Update Submit

March 23, 2023

Conditions

Malignant Neoplasms of Independent (Primary) Multiple Sites

Keywords

Malignant neoplasms of independent (primary) multiple sitesGastrointestinal symptomsProbioticsYogurtStool sampleQuestionnairesSurveysHolter monitor

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (1)

Adherence Rate of Dannon® Oikos® Yogurt Intake
12 days

Study Arms (2)

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.

Other: Tongue AssessmentOther: Stool SampleBehavioral: QuestionnairesDevice: Holter MonitorOther: 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.

Other: Tongue AssessmentOther: Stool SampleBehavioral: QuestionnairesDevice: Holter MonitorOther: Yogurt

Interventions

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.