| CTRI Number |
CTRI/2024/07/071611 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Use of Probiotics in Children with Iron deficiency anemia |
|
Scientific Title of Study
|
Effectiveness of probiotics in treatment of iron deficiency anemia in children - Open labelled comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nuka Mohith Reddy |
| Designation |
MD Paediatrics Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College and Researchh Institue, Pondicherry |
| Address |
Room number 10, OPD no 21, Pediatrics OPD, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry, India- 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9945955207 |
| Fax |
|
| Email |
mohithreddy1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ilamaran V |
| Designation |
Professor MD Paediatrics |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, Pondicherry |
| Address |
Room no 9, OPD no 19, Mahatma Gandhi Medical College and Research Institute, Pillayarkupam, Pondicherry, India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443289524 |
| Fax |
|
| Email |
ilamaran80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nuka Mohith Reddy |
| Designation |
MD Paediatrics Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College and Researchh Institue, Pondicherry |
| Address |
Room number 10, OPD no 21, Pediatrics OPD, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry, India- 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9945955207 |
| Fax |
|
| Email |
mohithreddy1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Dr Nuka Mohith Reddy |
| Address |
Room number 10, OPD no 21, Pediatrics OPD, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry, India- 607402 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Nuka Mohith Reddy |
Mahatma Gandhi Medical College and Research Institute |
Room number 10, OPD no 21, Pediatrics OPD, Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry, India- 607402
Pondicherry
PONDICHERRY |
9945955207
mohithreddy1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Research Institute Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hemoglobin and Ferritin |
Hemoglobin and Ferritin will be checked at the beginning of study and the end of therapy at 4-6 weeks |
| Intervention |
Iron alone |
The iron preparation used in this study was a liquid form of colloidal iron, 5ml of which contained 80 milligram of elemental iron, 200 microgram of folic acid and 2 microgram of vitamin B12.
Dose is given at 3mg/kg/day
Route of administration is Per orally once at night
Therapy duration 4-6 weeks |
| Intervention |
Iron with Probiotics |
Iron syrup preparation using in this study will be in the form of colloidal iron, 5ml of which contained 80 milligram of elemental iron, 200 microgram of folic acid and 2 microgram of vitamin B12.
Dose given at 3mg/kg/day
Route of administration is Per orally once at night.
Therapy duration 4-6 weeks
Each 5ml of liquid preparation of the probiotic used in this study contained Streptococcus faecalis T-110 JPC – 30 million CFU (colony forming unit), Clostridium butyricum TO-A – 2 million CFU, Bacillus mesentricus TO-A JPC – 1 million CFU and Lactobacillus sporogenes – 50 million CFU.
Dose is 5ml daily twice
Route of administration is per oral
therapy duration 4-6 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with iron deficiency anemia |
|
| ExclusionCriteria |
| Details |
-Children with recent blood transfusion (within last 3 months)
-Children with hemolytic disorders
-Children with malignancies
-Children with Chronic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean difference in haemoglobin and ferritin between the children treated with Probiotics-Iron and Iron alone group |
4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the compliance and tolerability between children treated with probiotics-iron and Iron alone |
4-6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/08/2024 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Data will be made available along with publication as supplementary material
- For how long will this data be available start date provided 30-05-2024 and end date provided 31-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an Open labelled study in Children with iron deficiency anemia who are filling the inclusion criteria and are divided into two groups based on sequential sampling.
Both groups receive same oral iron therapy but group A will additionally receive Probiotics. The duration of the study is 4-6 weeks. Haemoglobin and Sr.ferritin will be performed at the beginning of the study period and after 4-6weeks of therapy. The difference of Hemoglobin and ferritin will be compared between the groups |