Be part of a clinical trial for the prevention of allergic disease

A clinical trial is a human health-related research study that is designed to test the health effects of an experimental product. A clinical trial follows a set protocol that defines the objectives, participants, procedures, outcomes and safety monitoring of the study. Clinical trials of experimental treatments are regulated by national health authorities (i.e., U.S. Food and Drug Administration (FDA) or other national regulatory body) and are conducted under the supervision of an Institutional Review Board’ (IRB) or ‘Ethics Committee (EC) that is responsible for providing oversight for the safety of participants and integrity of the data produced. As standard with all clinical trials, you will be asked to read and sign an informed consent which allows your baby to take part in the study.

The type of bacteria in the human gut during infancy may affect the development of allergic diseases later in life. This study is testing whether administration of specific bacteria to infants may help prevent allergic diseases. This trial will be testing the safety and efficacy of an experimental treatment called STMC-103H. STMC-103H is a live biotherapeutic (medication made of live organisms) that contains a combination of bacteria that are normally found in the human gut and that may affect the development of allergic disease in newborns and children.

This study will test the ability of STMC-103H to reduce or prevent the development of allergic conditions in newborns who may be at risk for developing allergic diseases based on a history of allergic disease in the immediate family. Researchers will also monitor for changes in your child’s stool bacteria and immune system to see if STMC-103H affects any change in the bacteria in your child’s gut. You can learn more about this study here.

Our bodies contain a large collection of bacteria, fungi, viruses and other microbes together called the microbiome. Some bacteria may be beneficial by contributing to human digestion, programming the immune system, providing nutrients for our cells, and preventing colonization by harmful bacteria and viruses. Studies have found that the type of bacteria in the human gut during infancy may affect the development of allergic diseases later in life by reprogramming the developing immune system. This study is testing whether administration of specific bacteria may help prevent allergic diseases in newborns who are at risk for developing allergic diseases later in life.

If your child meets the qualifications for this study, you will be provided with the study drug [STMC-103H or placebo (i.e., an inactive substance)] that you will give to your child mixed with their breastmilk or formula once a day for approximately one year (336 days). After the last dose of STMC-103H or placebo is taken, your child will remain in the study for an additional one year (336 days) to collect additional samples and monitor your child for safety purposes.

STMC-103H is not a probiotic. STMC-103H is an investigational live bacterial product (LBP) which is made of naturally occurring bacteria that may be important for human gut health and is regulated by the FDA as a drug. As an LBP, it is subjected to stricter manufacturing controls to ensure high quality, potency, and consistency of the product. In addition, LBPs are required to show safety and effectiveness through regulated clinical trials like this one. Your participation in studies like this is absolutely crucial for the development of safe and effective drugs.

Although both probiotics and LBPs are made of living bacterial cells, probiotics are regulated as foods and primarily originate from food sources.

Participation in clinical trials allows your child to take part in the study of a new research treatment. Participation contributes important knowledge in testing a new investigational treatment to determine if it can reduce or prevent the development of allergic diseases in newborns who are at increased risk for developing allergic conditions. The study drug, study-related procedures, and study visits will be provided to your child, at no charge to you. Participation in a clinical trial is completely voluntary. You may withdraw your child’s participation in the trial at any time without penalty.

This study has an approximate one-year (336 days) study treatment period when your child will receive a dose of either active drug or placebo drug every day, followed by an approximate one-year (336 days) observation period when no treatment will be given. Your child will be seen by the study doctor and provide samples for the research during the two-year (672 days) study. However, your child’s participation in research is always voluntary. You are free to withdraw consent for your child’s participation at any time without penalty to you or your child. If you withdraw your child from the study, your child will continue to have access to regular medical care as before.

The study drug, study-related procedures, and study visits will be provided to your child, at no charge to you. Every clinical center will provide reimbursement for travel costs and a small stipend to compensate you for your time. If you wish to learn more, discuss these options with the clinical / study site closest to you for more information.

Privacy and safety are the top priorities for all clinical / study centers participating in this clinical trial. Every study procedure is performed by a medical health professional who is trained in and held accountable to state and federal privacy requirements. Neither your child’s name nor any other personal identifiers will be used in the study data. Instead, all samples and data will be coded with an identification number that will not be traced back to your child’s personal or health information. All information collected during the study will be maintained in a secure, encrypted, password-protected system.

Your child will receive either STMC-103H or a placebo once daily for approximately one year (336 days). STMC-103H is an experimental live biotherapeutic product (LBP) which consists of living bacteria that may be beneficial for human gut health. The placebo is an inactive powder that has no treatment value but is used to provide a comparison to the experimental LBP to assess how effective the experimental treatment actually is. The group of participants who receive the placebo are known as the “control group”. STMC-103H is considered investigational because it is not yet approved by the U.S. Food and Drug Administration (FDA) (or appropriate regulatory authority). The FDA (or appropriate regulatory authority) has approved this study. Both STMC-103H and placebo are provided as a powder in a capsule that is mixed with breastmilk or formula. In this study, approximately half of the participants will receive the placebo, and half will receive STMC-103H. No one will know which product your child is receiving (active treatment or placebo), including the study doctor or study team.

If you are interested in having your newborn participate in this trial, you should answer the pre-qualification questions above. If your child meets all of the criteria, you may speak directly with a study nurse at a nearby clinical / study center about whether your child meets qualifications for enrollment. The study nurse at your selected center will be able to answer all of your questions about the study itself and the enrollment process. After you speak to the study nurse, you may decide whether or not you want your child to participate in the trial. The choice to participate is completely yours.