What to Expect

Understanding Clinical Trials

What happens during the study?

The study has two parts: Part A and an optional Part B.

PART A

1.

1 visit

Screening

2.

Study Treatment and Follow-up

6 visits*

Part A lasts up to 24 weeks from the first dose and is for all participants who meet certain criteria to take part in the study.

Study treatment is either the investigational therapy CP101 or placebo. Your chance of receiving CP101 is two times higher than that of receiving placebo.

PART B

(OPTIONAL)

3.

Part B is optional. Not everyone will be able to enter Part B of the study. You may be able to take part in Part B of the study if you develop diarrhea which tests positive for C. diff in the first 8 weeks after taking study drug in Part A.

Everyone in Part B receives the investigational therapy CP101 (there is no chance of receiving placebo in Part B).

*Visits will happen at the clinic or, if you prefer, at your home when possible.

What happens during the study?

The study has two parts: Part A and an optional Part B.

PART A

1.

1 visit

Screening

2.

Study Treatment and Follow-up

6 visits*

Part A lasts up to 24 weeks from the first dose and is for all participants who meet certain criteria to take part in the study.

Study treatment is either the investigational therapy CP101 or placebo. Your chance of receiving CP101 is two times higher than that of receiving placebo.

PART B

(OPTIONAL)

3.

Part B is optional. Not everyone will be able to enter Part B of the study. You may be able to take part in Part B of the study if you develop diarrhea which tests positive for C. diff in the first 8 weeks after taking study drug in Part A.

Everyone in Part B receives the investigational therapy CP101 (there is no chance of receiving placebo in Part B).

*Visits will happen at the clinic or, if you prefer, at your home when possible.

What is screening?

The screening visit will happen at the study center or at your home. Before you start the study, you will need to give your permission by signing an Informed Consent Form. You will then answer questions about your health and have tests to make sure the study is right for you.

During screening, you will start or continue a course of antibiotics for C. diff infection.

What medicine would I take?

If eligible, you will be placed by chance into one of the two groups.

CP101

If you are in the CP101* group, you will receive the investigational therapy.

Placebo

If you are in the placebo group, you will receive a pill that looks exactly like CP101 but does not have any active medicine in it.

*CP101 is a microbiome therapy that contains a collection of healthy bacteria designed to correct the balance of the intestinal bacteria. It is not yet approved for use to treat recurrent C. diff infection and can only be used in a study. 

Your chance of receiving CP101 is two times higher than that of receiving placebo.

Neither you nor your doctor will know which group you are in.

What kind of tests and health checks
would I have during the study?

During the study, you will have visits for health checks and tests. Visits will happen at the clinic, over the phone, or, if you prefer, at your home when possible.

Some of the tests and health checks you would have are listed below. You would not have every test at each visit.

Health information
Medicine review
Questionnaires
and a diary
Vital signs (blood pressure, temperature, heart rate)
Physical exam
Heart activity (ECG)
Blood tests
Urine tests
Stool test
Pregnancy test

You would also be given an electronic diary (eDiary) to use during the study to record your symptoms and how you are feeling every day. The study team will explain to you how to use the diary.

Being in the study is voluntary and you can leave the study at any time.

For more information on the PRISM4 Study, talk to your doctor, or call

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