About the Trial | Chemo Gut

About the Chemo-Gut Probiotic Trial

Evaluating a New Probiotic for Survivors of Cancer

The Chemo-Gut Probiotic Trial uses a double-blinded placebo-controlled design, in which cancer survivors who have undergone chemotherapy will be randomly assigned to take either a novel oral probiotic treatment or a placebo pill, once daily, for 12 weeks.

The purpose of this study is to determine whether the probiotic treatment impacts gastrointestinal symptoms, mental health, and the gut microbiome.

Publications

What would I be Asked to do?

6 Weeks

12 Weeks

Pre-treatment

12 Weeks

Step 1

Contact the Study Team

If you are interested in participating, you may contact the study team.

Step 2

screening Call

A Research Assistant will schedule a phone call with you to confirm your eligibility, discuss the trial, and answer any questions you may have.

Step 3

Informed Consent

Before starting the trial, you will be required to sign a virtual informed consent form.

Step 4

Receive study products

A Research Assistant will schedule to drop of the study products and your stool samples collection kit at your house.

Step 5

Questionnaire 1

Before taking the study product, you will be asked to complete an approximately 30 minute long online questionnaire which will ask about your demographics, clinical characteristics, diet, mental health, and gut health.

Step 6

Collect a Stool Sample

Before you start taking the study product, you will be expected to collect a stool sample and store it in the freezer. A Research Assistant will pick your sample up within three days.

Step 7

Questionnaire 2

You will be asked to complete an approximately 20 minute long online questionnaire which will ask about your diet, mental health, and gut health since the previous questionnaire.

Step 8

Questionnaire 3

Once you have completed the study product, you will be asked to complete an approximately 20 minute long online questionnaire which will ask about your diet, mental health, and gut health since the previous questionnaire.

Step 9

Collect a Stool Sample

Once you have completed the study product, you will be expected to collect a stool sample and store it in the freezer. A Research Assistant will pick your sample up within three days.

Commonly Asked Questions about Participating

Potential Probiotic Side Effects: Although not expected, you may experience side effects from participating in this study. Some side effects may include bloating and/or gas, or diarrhea, but should subside after using the probiotic consistently. It is possible there may be side effects that are not expected. If this happens, you should discuss these with the study doctor. Also, there may be unknown risks with taking the investigational products.

Potential Pregnancy Risks: There are no known or anticipated risks associated with probiotic treatment. However, as a precaution women who are planning to become pregnant during the study will not be eligible, and women who become pregnant during the study will be withdrawn as a participant. If you become pregnant while participating the study, you must stop taking the investigational products and you should immediately notify the study doctor.

The expected benefits from taking part in this study may include reduced gastrointestinal symptoms and improved mental health. As part of our commitment to knowledge translation, each participant will receive a personalized report of their results which will be interpreted for all patient reported outcomes and gut microbiota profiling, in addition to helpful resources for further education.

However, please note that there is no guarantee that the intervention may be of direct benefit to you. Nevertheless, based on the results of this study, it is hoped that in the long-term, patient care will be improved.

All information provided by you will be treated with full confidentiality. Initially participants will be assigned an ID number and this will be used on all forms to protect your identity. The information and data gathered from you during the study will be used to answer the research question of this study and will only be accessible to the research team. Data collected will be stored in a password-protected computer and is only available to the researchers. Hard copy data (paper etc.) will only be kept in the researcher’s office and locked in a specific drawer/filing cabinet at the Holy Cross Centre. All data will be stored according to ethics board regulations following the completion of the study.

All research data gathered for the study may be used within presentations, publications, and other research purposes. Whenever your data is used, no personal information will be included and your identity will always be kept confidential.

*If you have any questions about your eligibility, please contact the study team!