Eligibility to Participate
The ORBEX Study is limited to participants who meet the following requirements:
- Child is between the ages of 5 - 16 months;
- Must meet at least one of the following criteria; and
- One of the child’s parents has asthma or has been diagnosed with asthma in the past
- Child has been diagnosed with eczema
- Child has a blood sibling, over 4 years of age, with a diagnosis of asthma
- Child has at least one parent/legal guardian who has a working cell phone and can communicate with study staff.
Study Treatment Introduction
What is the Study Product?
Participants will either receive a capsule of Broncho-Vaxom or a placebo.
Broncho-Vaxom ® is an extract of different, naturally occurring bacterial species frequently responsible for respiratory infections. These bacterial species stimulate the immune system, similar to how a vaccine works, in order to increase the body’s natural defenses agains a wide spectrum of respiratory pathogens. Broncho-Vaxom is currently used in Europe to prevent and/or reduce the severity of chronic bronchitis and recurrent respiratory infections.
The placebo consists of non-active ingredients.
How to Administer Study Product (Broncho-Vaxom or Placebo)
Open the capsule that is filled with a little bit of powder. The powder can then be mixed with fruit juice or other liquid for your child to drink.
When to Administer Study Product
One capsule is to be taken for 10 consecutive days each month, starting on the same day each month.
Possible Adverse Effects
Broncho-Vaxom has been used safely by more than 43 million children worldwide, but as part of the study your child will be closely monitored. Potential adverse reactions to Broncho-Vaxom include diarrhea (6 out of 100) or headache (5 out of 100), both of which are about the same rate as children who were taking the placebo, which has no active ingredients.
What to Expect When Participating in the Study
If your child is determined to be eligible to participate in the study, and you consent for him/her to participate, there are a number of procedures that your child will experience. You should also expect regular communication with clinical staff through the duration of the study.
Procedures
Physical Exam: Study staff at the clinical site will take the weight and height measurements of your child and examine your child’s lungs, skin, nose and mouth. A physical will be conducted during every in-person visit, a total of 12 times over a three-year period.
Blood Samples: Study staff at the clinical site will take a blood sample, about two teaspoons, from your child to test for inflammation and see what your child might be allergic to. A blood test will be conducted 3 times over a three-year period.
Nasal wash/swab: Study staff at the clinical site will conduct a nasal wash or swab on your child to test for bacteria or viruses in your child’s nose. The salt water used in the wash is similar to the makeup of tears. A nasal wash/swab will be conducted 3 times over a three-year period.
Stool Sample: Study staff at the clinical site will take a stool sample from your child. Stool samples will be taken 3 times over a three-year period.
Pulmonary Function Test: Study staff at the clinical site will conduct a breathing test on your child to test how well your child’s lungs are working. A breathing test will be conducted 5 times over a three-year period.
Communication with Clinical Staff
Communication is a key to the success of the ORBEX Clinical Trial. As a parent or guardian, you should know that your child will be closely monitored throughout the three-year treatment and observation period. This will be achieved through in-person visits and phone calls, and text messaging. There will be a total of 12 in-person visits over a three-year period. In months that you do not have a an in-person visit, you will receive a phone call, lasting roughly 10 minutes; there will be 26 telephone calls over a three-year period. Lastly, you will receive a text message weekly to check on your child’s breathing health and during the treatment phase. You may also receive a reminder text message to start giving your child the medication every month.
Given that text messaging and phone calls are such an important part of the study, you must have a cell phone that can receive and send text messages throughout your child’s participation in this study.
If your child develops wheezing symptoms or other breathing problems, the clinical staff are available to help. We will provide you with instructions and possibly medications to use. You can also contact the clinical staff to get advice. In many cases, the clinical staff will also ask you to come in for a brief visit.
Health Monitoring
As part of this clinical trial, your child’s lung health will be monitored during the duration of the study through in-person visits, phone calls and text messages. But if your child has wheezing symptoms outside the in-person visits, we may ask you to bring your child into the clinic to be examined by ORBEX clinical staff.
Compensation
We understand that the key to success is through our participants and recognize the value of their time. Participants will be compensated for time and travel.
Participant Timeline
The total length of the study is three years, with two years of treatment and one year of observation. Below is the timeline for you and your child and what is to be expected over the three-year period.
1 st
Visit
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Visit 1: At this first visit, you and your child will go to the research clinic and be given an overview of the ORBEX Clinical Study, which includes a walk-through of the informed consent form. During this visit you will be asked about your child’s medical history and to complete a number of questionnaires. You will also be asked if you have a cell phone that can send and receive text messages; you must have a phone that can to participate in this study.
You will be given a set of practice capsules, which have no active ingredients, to see if you can stay on schedule in giving your child the capsules; this first month of the study is called the run-in period. In addition to practice capsules, you will start receiving text messages from clinical staff. You will be sent a text message to remind you to start giving your child the practice capsules and will be sent an additional text each week to check in on your child’s breathing, which you will be required to respond to.
Procedures Conducted: Physical
Time Estimate: 2 hours
2 nd
Visit
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Visit 2: The second visit will occur 1 month after the first visit. During this visit clinical staff check your practice capsules to see if you have followed directions for the month and make sure you and your child still want to participate in the study.
If you want to continue, your child will be examined by a doctor and have his/her blood drawn. Additionally, you will be asked fill out a few questionnaires about your your child’s health.
Once complete, your child will then be randomly assigned to either take a capsule containing Broncho-Vaxom® or a placebo capsule (no active ingredients) during the treatment phase of the study. Neither you nor the doctor will know which capsule your child is taking; it will be kept secret and never change. This information can be released only if medically necessary.
Once assigned, you will be given enough capsules to last until the next in-person visit.
Procedures Conducted: Physical, Stool Sample, Blood Draw
Time Estimate: 2 hours
3 rd
Visit
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Visit 3: The third visit will occur 1 month after the second visit and during this visit your child will be examined by the doctor, and a nasal wash/swab will be conducted on him/her. The clinical staff will also check to make sure your child is taking the capsule as required and that you are receiving and answering the study text messages. You will then be given enough capsules to last until your next in-person visit.
Procedures Conducted: Physical, Nasal Wash/Swab
Time Estimate: 1 1/2 hours
Monthly Call 1: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 2: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
4 th
Visit
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Visit 4: The fourth visit will occur three months after your third visit. During this visit your child will be examined by the doctor. The clinical staff will also check to make sure your child is taking the capsule as required and that you are receiving and answering the study text messages. You will then be given enough capsules to last until your next in-person visit.
Procedures Conducted: Physical
Time Estimate: 1 1/2 hours
Monthly Call 3: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 4: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 5: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
5 th
Visit
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Visit 5: The fifth visit will occur four months after your fourth visit. During this visit your child will be examined by the doctor. The clinical staff will also check to make sure your child is taking the capsule as required and that you are receiving and answering the study text messages. You will then be given enough capsules to last until your next in-person visit.
Procedures Conducted: Physical
Time Estimate: 1 1/2 hours
Monthly Call 6: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 7: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 8: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
6 th
Visit
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Visit 6: The sixth visit will occur four months after your fifth visit. During this visit your child will be examined by the doctor. The clinical staff will also check to make sure your child is taking the capsule as required and that you are receiving and answering the study text messages. You will then be given enough capsules to last until your next in-person visit.
Procedures Conducted: Physical
Time Estimate: 1 1/2 hours
Monthly Call 9: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 10: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 11: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
7 th
Visit
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Visit 7: The seventh visit will occur four months after your sixth visit. During this visit your child will be examined by the doctor. The clinical staff will also check to make sure your child is taking the capsule as required and that you are receiving and answering the study text messages. You will then be given enough capsules to last until your next in-person visit.
Procedures Conducted: Physical
Time Estimate: 1 1/2 hours
Monthly Call 12: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 13: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 14: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
8 th
Visit
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Visit 8: The eighth visit will occur four months after your seventh visit. During this visit your child will be examined by the doctor and a breathing test will be conducted on your child. The clinical staff will also check to make sure your child is taking the capsule as required and that you are receiving and answering the study text messages. You will then be given enough capsules to last until your next in-person visit.
Procedures Conducted: Physical, Breathing Test
Time Estimate: 1 1/2 hours
Monthly Call 15: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 16: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 17: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
9 th
Visit
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Visit 9: At the two year anniversary, you and your child will come into the clinic and the doctor will examine your child, a breathing test and nasal wash/swab will be conducted on your child and blood will be drawn from your child. Additionally, the clinical staff will check to make sure that your child has taken the study capsule as required, and that you are receiving and answering the study text messages.
Procedures Conducted: Physical, Breathing Test, Stool Sample, Blood Draw, Nasal Wash/Swab
Time Estimate: 2 hours
Monthly Call 18: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 19: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 20: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
10 th
Visit
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Visit 10: The tenth visit will occur four months after the ninth visit. During this visit the doctor will briefly examine your child and a breathing test will be conducted on your child. Additionally, the clinical staff will check to see if you are receiving and answering the weekly text messages.
Procedures Conducted: Physical, Breathing Test
Time Estimate: 1 hour
Monthly Call 21: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 22: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 23: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
11 th
Visit
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Visit 11: The eleventh visit will occur four months after the tenth visit. During this visit the doctor will briefly examine your child and a breathing test will be conducted on your child. Additionally, the clinical staff will check to see if you are receiving and answering the weekly text messages.
Procedures Conducted: Physical, Breathing Test
Time Estimate: 1 hour
Monthly Call 24: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 25: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
Monthly Call 26: You will receive a phone call that will last around 10 minutes to check in and see how your child is doing. During the call, clinical staff will ask about your child’s asthma or wheezing symptoms, medication use, and whether your child has seen the doctor.
Time Estimate: 10 minutes
12 th
Visit
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Visit 12: This is the last in-person visit and will occur four months after the eleventh visit. During this visit the doctor will briefly examine your child and a breathing test and nasal wash/swab will be conducted on your child, and blood will be drawn from your child. Lastly, you will be asked to complete a few questionnaires.
Procedures Conducted: Physical, Breathing Test, Stool Sample, Blood Draw, Nasal Wash/Swab
Time Estimate: 2 hours
