Study on Beta Glucan as a nutritional supplement in children undergoing chemotherapy

An Open Label, Prospective, Randomized, Comparative Clinical study to Evaluate the effects of AFO-202 strain of Aureobasidium Pullulans Produced ß1,3-16 Glucans (Nichi BRITE) in patients with hematological malignancies undergoing myeloablative chemotherapy before hematopoietic stem cell transplantation (HSCT) - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075871

Enrollment

Registered

2024-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Interventions

Intervention1: Nichi BRITE Beta-glucan: Dose: 1.5 g Dosage: Two sachets per day Treatment Duration: 24 days Route of Administration: Oral Control Intervention1: None. Conventional Therapy: NIL. N

Eligibility

Inclusion criteria

Inclusion criteria: • Children scheduled for myeloablative chemotherapy before HSCT. • Able to provide written informed consent by Guardian/Parent.

Exclusion criteria

Exclusion criteria: 1. Poor renal function (creatinine clearance less than 10 mL/sec or glomerular filtration rate less than 15) 2. Hemochromatosis 3. Current use of any other nutritional supplements

Design outcomes

Primary

Measure	Time frame
Blood Markers : CD209, CD4, CD8, CD16, CD56, IgA, SAA, ButryateTimepoint: Baseline, Day 0, Day 14, Day 21, Day 24	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr Preethy

MediNippon Healthcare Private Limited

drspp@nichimail.jp9444927694

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026