| CTRI Number |
CTRI/2025/11/097860 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
We are doing a study of the effect of probiotics (good bacteria) in children admitted to the hospital suffering from fever, wether it could help them recover faster. |
|
Scientific Title of Study
|
Effect of probiotics on duration of acute febrile illness in hospitalized pediatric patients, randomized, double blind placebo controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Salunkhe Shailesh |
| Designation |
DNB Trainee |
| Affiliation |
Ruby Hall Clinic |
| Address |
Department of Pediatrics, P ward,
Ruby Hall Clinic,
40, sassoon road, Pune
40, sassoon road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8180931266 |
| Fax |
|
| Email |
shaileshsalunkhe25@gmail.com.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kanchankumar Bhagyawant |
| Designation |
Consultant Pediatrician |
| Affiliation |
Ruby Hall Clinic |
| Address |
Department of Pediatrics, P ward,
Ruby Hall Clinic,
40, sassoon roar, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9860937972 |
| Fax |
|
| Email |
drkanchankumar@rubyhall.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Kanchankumar Bhagyawant |
| Designation |
Consultant Pediatrician |
| Affiliation |
Ruby Hall Clinic |
| Address |
Department of Pediatrics, P ward,
Ruby hall clinic,
40, sassoon road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9860937972 |
| Fax |
|
| Email |
drkanchankumar@rubyhall.com |
|
|
Source of Monetary or Material Support
|
| Ruby Hall Clinic, 40, sassoon road, Pune, maharashtra, India 411001 |
|
|
Primary Sponsor
|
| Name |
DR SHAILESH SALUNKHE |
| Address |
Ruby Hall clinic, 40, sassoon road, Pune 411001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHAILESH SALUNKHE |
Ruby Hall Clinic |
P ward, Department of Pediatrics, 40, sassoon road, Pune
Pune
MAHARASHTRA |
8180931266
shaileshsalunkhe25@gmail.com.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POONA MEDICAL RESEARCH FOUNDATION INSTITUTIONA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical Placebo |
Maltodextrin powder packed in identical sachet like the intervention drug |
| Intervention |
PROBIOTIC |
Probiotic containing Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Bifidobacterium Longum, Bacillus Coagulans, Saccharomyces Boulardii in a sachet |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Child hospitalized with acute febrile illness
Patient/ Parents willing to participate
|
|
| ExclusionCriteria |
| Details |
Recent use of probiotics in preceding 2 weeks
Any autoimmune illness, any chronic illness
Patient on immunosuppressive treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine fever duration
2.To determine duration of illness
|
1.Baseline
2.7 days
3. At the recovery of the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine any adverse effects |
1. Baseline
2. 7 days
3. At the recovery of the patient |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Acute febrile illnesses (AFIs) are a major cause of pediatric hospital admissions worldwide, leading to prolonged stays and high healthcare costs. While supportive and antimicrobial care are standard, probiotics—known for their immune and gut-modulating properties—may help shorten illness duration. However, hospital-based evidence in children remains limited. This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of probiotics on the duration of acute febrile illness in hospitalized children (1–18 years). Fifty participants will be randomized into two groups: Intervention group: receiving a probiotic mixture (Lactobacillus acidophilus, L. rhamnosus, Bifidobacterium longum, Bacillus coagulans, and Saccharomyces boulardii).Control group: receiving an identical placebo (maltodextrin). Primary outcomes: fever duration and total illness duration.
Secondary outcome: any adverse effects. Eligible children are those hospitalized with AFI and without chronic or immunosuppressive conditions. The study will run for six months after ethics approval, with no external funding or follow-up period. This study seeks to fill an important research gap by providing evidence on whether probiotic supplementation can safely and effectively reduce fever duration and recovery time in hospitalized pediatric patients. |