Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT06767592
Eligibility Criteria:
Inclusion Criteria:
1. Biopsy-proven IgAN
2. Age 18 years or older
3. Able and willing to give informed consent
4. Sufficient understanding of English to understand the patient information sheet and complete questionnaires
5. No change in medications for 6 weeks up to the Baseline visit
6. Stable diet (e.g. not a change to elimination, reduction, vegan or vegetarian diet) for 30-days prior to the baseline visit and during the study
Exclusion Criteria:
1. Aged \<18 years
2. Unable or unwilling to give informed consent
3. eGFR \< 45 ml/min/1.73 m2 (measured by CKD-EPI formula)
4. Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days
5. Predicted to change diet during the study
6. Any of the following conditions:
6.1. Autoimmune disease (e.g. systemic lupus erythematosus) 6.2. Serious gastro-intestinal illness (including Crohn's disease, ulcerative colitis, chronic liver disease, significant gastrointestinal surgery or cancer, pancreatitis, motility disorder) 6.3. Diagnosed infectious illness within the previous 30-days
7. Prescribed any of the following medication within the previous 60-days 7.1. Antibiotics or anti-viral medications 7.2. Steroids or other immunosuppressive agents
8. Any other condition which in the opinion of the investigator could interfere with the study
9. Enrolled in a clinical trial of an investigational medicinal product
10. Allergy to any component of BioKult Advanced (including milk or soy allergy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06767592
Study Brief:
Protocol Section:
NCT06767592