Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with ulcerative colitis.
• People who have signs of active disease, either through a stool test result showing inflammation (fecal calprotectin above 100 µg/g), or through a symptom score meeting a certain threshold — this applies to both adults and children, including those whose symptoms are mild but whose stool test still shows inflammation.
• Children who have reached at least Tanner stage 4 of physical development (a measure of puberty progression — confirm with trial site).
• People who weigh more than 40 kg (about 88 pounds).
• People whose medications for bowel disease have stayed the same for the three months before the study starts, with only minor adjustments allowed (such as a dose change due to weight gain, or switching to an equivalent generic version).
• People who use adequate contraception (applies to both men and women).
• People who are able to keep their usual daily habits — including diet, exercise, sleep, and supplements — the same throughout the study.

Who may not be able to join:

• People who are unable to give informed consent to participate.
• People who have Crohn's disease, a type of bowel disease that cannot be clearly classified, non-inflammatory bowel conditions such as celiac disease, or a condition affecting how the gut moves food through.
• People who have abnormal narrowings in the digestive tract, conditions affecting the esophagus or the valve between the esophagus and stomach, any bowel blockage (existing or at risk), paralysis of the intestine, severely enlarged colon, impacted stool, inflamed bowel or appendix, or who have not had a bowel movement after using another laxative.
• People who have a history of serious ongoing health conditions, such as severe heart disease, cancer requiring chemotherapy or radiation, significant kidney failure, severe lung disease, kidney disorders, diabetes, arthritis, multiple sclerosis, or other immune-related conditions that require ongoing systemic treatment.
• People who have a serious active infection, such as an infection in the colon.
• People who have severe anaemia, defined as a haemoglobin level below 100 g/L, or a level considered clinically concerning by their doctor.
• People who have a condition that makes swallowing difficult, which could interfere with taking the study supplement.
• People who have used systemic antibiotics for more than one week in the two months before the trial starts, or who use any antibiotics during the trial itself.
• People who regularly use medications that slow down gut movement, such as opioid painkillers or loperamide.
• People who have been consistently using rectal treatments (such as suppositories or enemas) for at least a week and have had an improvement in symptoms as a result.
• People who have used probiotic, prebiotic, or fibre supplements in the month before the trial or plan to use them during the trial — note that these ingredients in everyday foods such as yogurt or fermented foods are allowed.
• People who regularly use laxatives, stool softeners, or anti-diarrhoeal medications.
• People who regularly use illicit drugs or drink excessively (for example, more than an average of 7 alcoholic drinks per week).
• People who currently smoke cigarettes.
• People who have had abdominal surgery in the past, including removal of the appendix.
• People who are pregnant or plan to become pregnant during the study.
• People who are breastfeeding.
• People who are allergic to any ingredients in the study products or placebo, which include acacia gum, microcrystalline cellulose, or maltodextrin.
• People who are unable to maintain a high fibre intake through supplementation during the trial.

Important: Always verify eligibility with the trial site directly before applying.