Glossary of Terms

Bacteria: Bacteria are microscopic single-celled organisms that thrive in diverse environments inside and outside the human body. The human digestive tract has as many as 1,000 different species of bacteria.

Blind experiment: A blind experiment is where specific information about the treatment given is withheld from the participant to reduce bias. The participant does not know whether they are getting the treatment under investigation or the placebo.

C. difficile: Clostridium difficile, often called C. difficile or C. diff, is a bacterium that can cause symptoms ranging from mild diarrhea to life-threatening inflammation of the colon.

Clinical Study: A research study using human volunteers to evaluate the safety and effectiveness of an investigational treatment, medication or device.

Clinical Trial: Often called an Interventional Study where participants are assigned one or more interventions or no interventions so that researchers can evaluate whether the intervention is safe and effective. Participants might receive diagnostic, therapeutic or other interventions.

Condition: The disease, disorder, illness or syndrome that is being studied in the trial.

Double-blind experiment: A double-blind experiment is where specific information about treatment is withheld from both the participant and the one doing the testing to reduce bias. Neither the person participating nor the tester knows whether the participant is getting the treatment under investigation or the placebo.

Ecobiotic® therapy: An ecology of healthy bacteria that are designed to correct intestinal bacterial imbalance, improve the immune system and restore the gut’s normal functioning.

Electrocardiogram: A vital sign test that checks for problems with a person’s electrical activity in the heart.

Endoscopy: a nonsurgical procedure used to examine a person’s digestive tract.

Food and Drug Administration (FDA): The agency within the U.S. Department of Health and Human Services that is responsible for protecting the public health. They make sure that human and veterinary research medications, vaccines and other biological products, medical supplies, food chain, cosmetics, dietary supplements, and products that give off radiation are safe, effective and secure.

Institutional Review Board (IRB) / Independent Ethics Committee (IEC): A group of people who review, approve, and monitor the clinical study protocol. Their role is to protect the rights and welfare of human research participants involved in any clinical study or trial. The board includes people with broad range of backgrounds to ensure that the research conducted by any organization is completely and adequately reviewed. The IRB is also responsible for the well-being of animals used for research purposes.

Intervention: The process or action that the clinical study is focusing on. An intervention can include medications, devices, procedures, vaccines or any other products that are either investigational or already available. They can also include surveys, education materials and interviews.

Investigator: A researcher involved in a clinical trial or study.

Microbiome: The human microbiome is the genetic material of all the microbes (bacteria, fungi, protozoa and viruses) the live on and inside the human body. It consists of approximately 40 trillion microorganisms. The bacteria found in the gut microbiome help digest our food, regulate our immune system and protect against other bacteria that cause disease.

Observational Study: A clinical study where participants are assessed for biomedical or health outcomes. These participants might receive diagnostic, therapeutic or other interventions but the investigator does not assign these interventions to a specific participant.

Phase: The description of the clinical trial that is based on the characteristics of the trial such as number of participants and objective of the trial itself.

Placebo: Treatment (which may include capsules) that contain no active medication.

Protocol: The written description of the entire clinical study. The protocol includes the objectives, design, and methods. It can also include relevant information such as the background and statistical analysis.

Randomized controlled trial: A type of scientific experiment where participants are randomly assigned to a group in the study. Commonly one group receives the treatment under investigation and another group receives the placebo. The random assignment is designed to reduce bias.

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References