The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values, including lab tests and vital signs, are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.
A clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase 1 tests a new drug or treatment in a small group of healthy individuals; Phase 2 expands the study to a larger group of people, including patients; Phase 3 expands the study to an even larger group of people; and Phase 4 takes place after the drug or treatment has been licensed and marketed.
Surgical removal of part (partial colectomy) or all of the colon.
The part of the large intestine extending from the cecum to the rectum.
Pertaining to the colon.
Inspection of the interior surface of the colon with a flexible endoscope that is equipped to obtain tissue samples and inserted through the rectum.
Surgical procedure where a portion of the large intestine is brought through the abdominal wall to carry stool out of the body.
Compassionate Use programs provide controlled, pre-approval access to investigational drugs for a specific cohort of patients before the investigational treatment is licensed for use in humans. This procedure is usually applied to cohorts of very sick individuals who have exhausted all other treatment options. Generally, approval must be obtained from the appropriate regulatory authorities, e.g., Health Canada. See also Named Patient Use.Demo Content
A type of inflammatory bowel disease (IBD) involving chronic inflammation of the gastrointestinal (GI) tract. The inflammation from CD can strike anywhere in the GI tract, from mouth to anus, but is usually located in the lower part of the small bowel (intestine) and the upper end of the colon (i.e., large intestine). Patches of inflammation are interspersed between healthy portions of the gut, and can penetrate the intestinal layers from inner to outer lining. For more information: Crohn’s and Colitis Foundation of Canada.
A research tool used to quantify the symptoms of participants with Crohn’s disease. For more information: CDAI
A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the investigational drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the study nurse/doctor and the participant about the investigational drug do not affect the outcome; also called double-masked study.
An instrument for visually examining the interior of a bodily canal or a hollow organ such as the bowel, bladder, or stomach. For example: colonoscopy.
To erupt or intensify suddenly, i.e., active disease. Opposite = remission.
A simpler version of the CDAI for data collection purposes. For more information: HBI
The study of diseased tissues at a minute (microscopic) level.
Surgical procedure whereby the end or a loop of small intestine (the ileum) is brought through the abdominal wall out onto the surface of the skin.
A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document by the study doctor or nurse. The participant then decides whether or not to sign the document. The informed consent form must be signed in order for the participant to participate in the clinical trial. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
The part of the alimentary canal extending from the pyloric opening of the stomach to the anus. Also known as the bowel(s).
The distal portion of the intestine, about 5 feet long, extending from its junction with the small intestine to the anus and comprising the cecum, colon, rectum, and anal canal.
Named Patient Use programs provide controlled, pre-approval access to investigational drugs in response to requests by physicians on behalf of a specific, or “named”, patient before the investigational treatment is licensed for use in humans. Regulations governing Named Patient Use vary from country to country. See also Compassionate Use
Participants who do NOT respond to study treatment, i.e., with a decrease in CDAI score between baseline and Week 8 of less than (<) 70 points.
When both study staff (nurses and doctors) and participants (patients) know which treatment (e.g., investigational drug) is being administered.
A synthetic narcotic that resembles the naturally occurring opiates.
Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side-effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or participants with the disease of interest.
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side-effects and risks.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebo treatments to assess the treatment’s effectiveness.
A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
QBECO is a member of Qu Biologics’ novel class of immunotherapies, called Site-Specific Immunomodulators (SSIs), which are designed to stimulate the innate immune response and thereby reverse the chronic inflammation underlying many chronic conditions including cancer, arthritis and inflammatory bowel disease. QBECO is a killed bacterial preparation based on a single species known to commonly infect the human colon.
An image produced on a radiosensitive surface, such as photographic film, by radiation other than visible light, especially by X-rays passed through an object or by photographing a fluoroscopic image. For example: Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Capsule Endoscopy, Small Bowel Follow Through.
A study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Placebos may be utilized.
Diminution or abatement of the symptoms of a disease. Opposite = active, flaring.
Participants who respond to study treatment, i.e., with a decrease in CDAI score between baseline and Week 8 of greater than or equal to (≥) 70 points.
Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Investigational drugs must be evaluated for both immediate and long-term side effects.
Qu Biologics’ proprietary drug platform for treating chronic inflammatory diseases, including cancer, inflammatory bowel disease (IBD) and arthritis. SSIs are preparations made from a single-species of killed bacteria. They act by stimulating the body’s own innate immune response.
The proximal portion of the intestine, about 20 feet long, smaller in caliber than the large intestine, extending from the pylorus to the cecum and comprising the duodenum, jejunum, and ileum.
A physician (doctor) in charge of carrying out an approved clinical trial protocol.
Measures of various physiological statistics, including but not limited to: body temperature, heart rate (pulse rate), blood pressure and respiratory rate.