Effects of Probiotics in Preventing Oral Mucositis

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be a randomized double blind prospective placebo controlled clinical study and aims to determine the therapeutic efficacy of Probiotics in Oral Mucositis pathogenesis in patients undergoing head and neck radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore

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)