Phase 2 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:

Healthy volunteers may be considered if they:

• Are aged 18 or older but under 50 years old
• Have a body mass index (BMI) between 17 and 25 kg/m² (a measure of body weight relative to height)
• Are a woman of childbearing age using an effective form of contraception (such as hormonal methods, an intrauterine device, a procedure to block the fallopian tubes, or complete abstinence from heterosexual intercourse) for at least the treatment period of the study
• Have regular bowel movements — at least one stool every two days and no more than three stools per day
• Have health insurance coverage (excluding AME)
• Are willing and able to provide written informed consent

People with Inflammatory Bowel Disease (IBD) — a condition causing long-term inflammation in the digestive system — may be considered if they:

• Are aged 18 or older but under 50 years old
• Have a confirmed diagnosis of Crohn's disease (not limited only to the upper digestive tract) or ulcerative colitis (not limited only to the rectum) for at least 6 months, based on recognised medical criteria
• Have been in remission (their condition has been stable and not actively flaring) for at least 6 months, without the use of steroid medications, and confirmed by specific disease activity scores (confirm with trial site)
• Have a BMI between 17 and 25 kg/m²
• Are a woman of childbearing age using a highly effective form of contraception, such as oral contraception, an intrauterine device, a hormonal device, sterilisation, or another method with a failure rate of less than 1%
• Have regular bowel movements — at least one stool every two days and no more than three stools per day
• Have health insurance coverage (excluding AME)
• Are willing and able to provide written informed consent

Who may not be able to join:

Healthy volunteers may not be eligible if they:

• Have a significant long-term illness, particularly a chronic digestive condition, type 1 or type 2 diabetes, or a kidney problem
• Are currently taking any long-term treatment for a medical condition
• Are pregnant or breastfeeding
• Have donated blood in the three months before the study starts
• Have taken antibiotic or antifungal medication by mouth in the three months before the first study visit
• Have taken probiotic supplements in the month before the first study visit
• Have followed a low-calorie diet or any other special diet (vegetarian diets are acceptable) in the month before the first study visit
• Have had any abdominal surgery in the past (except removal of the appendix)
• Have a known allergy to the antibiotics or antifungal medications used in this study, or to any of their ingredients
• Have medical reasons that prevent them from receiving a medication called gentamicin (confirm with trial site)
• Are currently taking part in any other interventional clinical trial
• Are under legal protection orders (confirm with trial site)
• Have abnormal blood test results at the screening visit, including problems with electrolytes, kidney markers, liver enzymes, thyroid hormone, or blood cell counts
• Have had an infection requiring antibiotic treatment after the screening visit
• Develop severe diarrhoea (seven or more extra stools per day above their normal level)

People with IBD may not be eligible if they:

• Are pregnant or breastfeeding
• Have donated blood in the three months before the study starts
• Have taken antibiotic or antifungal medication by mouth in the three months before the first study visit
• Have taken probiotic supplements in the month before the first study visit, or during the study
• Have had more than 50 cm of the small intestine (ileum) surgically removed, or have had their colon removed
• Have Crohn's disease that affects only the upper digestive tract (such as the oesophagus, stomach, or upper small intestine)
• Have ulcerative colitis that affects only the rectum
• Currently have a stoma (an opening in the abdomen to collect waste), have had one in the past six months, or have had any other abdominal surgery within the three months before joining
• Are currently taking part in any other interventional clinical trial
• Are under legal protection orders (confirm with trial site)
• Have had an infection requiring antibiotic treatment after the screening visit
• Experience a flare-up of their IBD during the study

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