Preventing fever in neutropenic children with cancer who are receiving chemotherapy by probiotic supplementation

Evaluating the role of probiotics in prevention of febrile neutropenia in children receiving intensive chemotherapy: A double blind randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041187

Enrollment

212

Registered

2022-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C920- Acute myeloblastic leukemia Health Condition 3: C419- Malignant neoplasm of bone and articular cartilage, unspecified Health Condition 4: C499- Malignant neoplasm of connective and soft tissue, unspecified Health Condition 5: C692- Malignant neoplasm of retina Health Condition 6: C859- Non-Hodgkin lymphoma, unspecified Health Condition 7: C7A8- Other malignant neuroendocrine tumors

Interventions

Intervention1: Lactobacillus rhanmnosus GG: Dose of 10,00,00,000 CFU/kg/day (vanilla flavoured granules) Oral administration Duration From first day of induction chemotherapy/first cycle of chemother

Eligibility

Inclusion criteria

Inclusion criteria: To be started on chemotherapy with expected >20% febrile neutropenia incidence or classified as highly myelosuppressive: a. ALL HR induction b. AML induction c. Soft tissue sarcomas d. NACT or Augmented chemotherapy for Retinoblastoma e. High risk Neuroblastoma f. Ewing’s Sarcoma g. Osteosarcoma

Exclusion criteria

Exclusion criteria: 1. Patients having received prior chemotherapy 2. Patients having coexisting GIT pathologies at presentation (e.g. Malabsorption, intestinal obstruction) 3. Patients documented to have taken probiotics in the past 6 months duration

Design outcomes

Primary

Measure	Time frame
Proportion of patients developed febrile neutropenia, as defined as fever more than 100F two episodes 1 hour apart or one episode of fever more than 101F with ANC of less than 500, in probiotic and placebo armsTimepoint: Assessment at the end of drug administration period, i.e, just prior to administration of second protocol/cycle of chemotherapy: Day 30 for leukemias, Day 20 for solid tumors	—

Secondary

Measure	Time frame
1. Proportion of patients developing culture positive sepsis with Lactobacillus identified in blood 2. Proportion of patients developing sepsis with likely GIT focus with no organism on blood culture 3. Proportion of patients developing sepsis with likely blood stream focus with no organism on blood culture Timepoint: During time of intervention till 1 week post stopping;Compare average number of days of antibiotics in both groupsTimepoint: During time of intervention till 1 week post stopping;Compare time to first febrile neutropenia episode, defined as days between first dose of chemotherapy to first day of fever, in both groupsTimepoint: During time of intervention till 1 week post stopping;Proportion of patients developing radiologically confirmed NEC (as defined as USG or CECT evidence of Bowel wall thickening of more than 3mm, a dilated cecum or other colonic segment, an inflammatory mass, peri colonic inflammation or pneumatosis intestinalis) on a background of fever, abdominal pain and neutropenia, in probiotic and placebo arms Timepoint: During time of intervention till 1 week post stopping	—

Measure

Time frame

1. Proportion of patients developing culture positive sepsis with Lactobacillus identified in blood 2. Proportion of patients developing sepsis with likely GIT focus with no organism on blood culture 3. Proportion of patients developing sepsis with likely blood stream focus with no organism on blood culture Timepoint: During time of intervention till 1 week post stopping;Compare average number of days of antibiotics in both groupsTimepoint: During time of intervention till 1 week post stopping;Compare time to first febrile neutropenia episode, defined as days between first dose of chemotherapy to first day of fever, in both groupsTimepoint: During time of intervention till 1 week post stopping;Proportion of patients developing radiologically confirmed NEC (as defined as USG or CECT evidence of Bowel wall thickening of more than 3mm, a dilated cecum or other colonic segment, an inflammatory mass, peri colonic inflammation or pneumatosis intestinalis) on a background of fever, abdominal pain and neutropenia, in probiotic and placebo arms Timepoint: During time of intervention till 1 week post stopping

—

Countries

India

Contacts

Public ContactAditya Kumar Gupta

All India Institute of Medical Sciences, Delhi

adivick@gmail.com7838379837

Outcome results

None listed

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