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CTRI Number  CTRI/2024/10/075871 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Study on Beta Glucan as a nutritional supplement in children undergoing chemotherapy 
Scientific Title of Study   An Open Label, Prospective, Randomized, Comparative Clinical study to Evaluate the effects of AFO-202 strain of Aureobasidium Pullulans Produced β1,3-16 Glucans (Nichi BRITE) in patients with hematological malignancies undergoing myeloablative chemotherapy before hematopoietic stem cell transplantation (HSCT) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
F58S-MDN/Apollo/24JUL24/Version-1 dated 24 Jul 24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preethy 
Designation  Overall Trial Coordinator 
Affiliation  MediNippon Healthcare Private Limited 
Address  Room No 1, Department of Research, Plot No, 6, Zakariah Colony, 3rd St, Choolaimedu,

Chennai
TAMIL NADU
600094
India 
Phone  9444927694  
Fax    
Email  drspp@nichimail.jp  
 
Details of Contact Person
Scientific Query  
Name  Dr Preethy 
Designation  Overall Trial Coordinator 
Affiliation  MediNippon Healthcare Private Limited 
Address  Room No 1, Department of Research, Plot No, 6, Zakariah Colony, 3rd St, Choolaimedu,


TAMIL NADU
600094
India 
Phone  9444927694  
Fax    
Email  drspp@nichimail.jp  
 
Details of Contact Person
Public Query  
Name  Dr Preethy 
Designation  Overall Trial Coordinator 
Affiliation  MediNippon Healthcare Private Limited 
Address  Room No 1, Department of Research, Plot No, 6, Zakariah Colony, 3rd St, Choolaimedu,


TAMIL NADU
600094
India 
Phone  9444927694  
Fax    
Email  drspp@nichimail.jp  
 
Source of Monetary or Material Support  
MediNippon Healthcare Pvt Ltd No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094, Tamil Nadu, INDIA  
 
Primary Sponsor  
Name  MediNippon Healthcare Pvt Ltd 
Address  No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094, Tamil Nadu, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramya Uppuluri  Apollo Cancer Centre  Counter no. 12; Department of Oncology, Plot No 320, Padma Complex, Teynampet, Chennai – 600 035
Chennai
TAMIL NADU 		 04424355003

ramya.december@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Bio Medical Research, Apollo Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C969||Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nichi BRITE Beta-glucan   Dose: 1.5 g Dosage: Two sachets per day Treatment Duration: 24 days Route of Administration: Oral  
Comparator Agent  None. Conventional Therapy  NIL. Not applicable. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  17.00 Year(s)
Gender  Both 
Details  • Children scheduled for myeloablative chemotherapy before HSCT.
• Able to provide written informed consent by Guardian/Parent.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Blood Markers : CD209, CD4, CD8, CD16, CD56, IgA, SAA, Butryate   Baseline, Day 0, Day 14, Day 21, Day 24 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


Study Design: This is a Open Label, Prospective, Randomized, Comparative Clinical Study

Indication: Hematological malignancies

Investigational Product:  Nichi BRITE Beta-glucan  
Comparator: None. Subjects in comparator arm will be receiving Chemotherapy no interventions are given.
Dose: 1.5g
Dosage:  Two sachets per day

Treatment Duration: 24 days

Route of Administration: Oral

Subject Population: Children scheduled for myeloablative chemotherapy before HSCT.

Number of Subjects: 40 Evaluable Subjects
Treatment Arms:  Two Treatment Arms
Treatment arm I   : Chemotherapy and Nichi BRITE Beta-glucan
Treatment arm II  : Chemotherapy

Assessments : Blood Markers : CD209,CD4, CD8, CD16, CD56) and IgA, SAA, Butryate levels
Timepoints : Baseline, Day 0, Day 7, Day 14, Day 21, Day 24

Background of the study: Hematopoietic stem cell transplantation (HSCT) is a treatment for life threatening diseases like hematopoietic malignancies, using stem cells from bone marrow or peripheral blood. The administration of beta glucan improves patient outcome during chemotherapy by modifying the immune system, gut microbiome and increasing endogenous butyrate levels.  

Purpose of the Study:  Nichi BRITE Beta-glucan, a water-soluble food supplement produced by the AFO-202 strain of Aureobasidium pullulans manufactured in Japan in a GMP facility. Nichi BRITE, an onconutrition adjuvant, has been proven to enhance immune biomarkers and decrease cancer-associated markers in pancreatic cancer patients. Therefore, this study is designed to evaluate the effects of Nichi BRITE Beta-glucan in children undergoing myeloablative chemotherapy before HSCT.

 
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