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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03552458
Eligibility Criteria:
Inclusion Criteria:
1. patients who are 21 years of age or older
2. histological diagnosis of head and neck carcinoma available
3. undergoing head and neck radiotherapy of at least 6000cGY
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
5. no known allergy to Biogaia
6. able to give written informed consent, or have written consent given on their behalf.
Exclusion Criteria:
1. patients who cannot use the products or have it administered to them
2. patients with existing conditions predisposing to oral ulcer formation
3. patients with mucositis at baseline (prior to initiation of treatment)
4. previous radiotherapy to the head and neck region
5. female patients who are pregnant or breastfeeding
6. patients who have central venous catheters
7. patients who have impaired intestinal epithelial barrier
8. patients who have cardiac valvular disease
9. unable to give written informed consent, or are unable to have written consent given on their behalf.
10. inability to converse in English or Mandarin
11. severe immunosuppression (Absolute Neutrophil Count of less than 1500 cells/µL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT03552458
Study Brief:
Protocol Section:
NCT03552458