| CTRI Number |
CTRI/2026/03/105287 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The study compares two commonly used medicines to see which baby with colic cry less and feel more comfortable |
|
Scientific Title of Study
|
Effect of Probiotics versus Probiotics combined with simethicone in the Management of Infantile Colic |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manthri Lochana latha sree |
| Designation |
first year Post Graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College |
| Address |
Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7036369096 |
| Fax |
|
| Email |
manthrilochana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T Bharath Kumar |
| Designation |
Proffesor and HOD Department of Paediatrics |
| Affiliation |
Sri Manakula Vinayagar Medical College |
| Address |
Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
T Bharath Kumar |
| Designation |
Proffesor and HOD Department of Paediatrics |
| Affiliation |
Sri Manakula Vinayagar Medical College |
| Address |
Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Puducherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet puducherry-605107 Kalitheerthalkuppam Puducherry |
|
|
Primary Sponsor
|
| Name |
Manthri Lochana Latha Sree |
| Address |
Room number 49,paediatrics OPD,department of paediatrics,Sri Manakula Vinayagar Medical College and hospital,kalitheerthalkuppam, Madagadipet, Puducherry-605107 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrManthri Lochana Latha Sree |
Sri Manakula Vinayagar Medical College |
Room No-49 Paediatric OPD Sri Manakula Vinayagar Medical College Madagadipet Kalitheerthalkuppam Puducherry-605107
Pondicherry
PONDICHERRY |
7036369096
manthrilochana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Term infants more than or equal to 37 weeks of gestation
Infants age between 0-12 months
Infants diagnosed with Infantile colic based on Wessel’s criteria
Crying more than 3 hours per day more than 3days per week more than 3 consecutive weeks
Term Infants and birth weight more than 2.5 kg
Exclusively or predominantly breastfed infants
Parents or guardians willing to participate and give written informed consent |
|
| ExclusionCriteria |
| Details |
Preterm infants
Infants with underlying gastrointestinal, metabolic, or neurological disorders
Infants receiving antibiotics, probiotics, or simethicone in the past 7 days
Known hypersensitivity to study medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in daily duration and frequency of crying episodes in infants with colic after 7 days of treatment. |
AT 7 TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to symptomatic relief & caregiver satisfaction (5-point Likert scale), assessed during follow-ups on days 14 & 28. |
AT 14 & 28 th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
My thesis consists of 80 sample size dividing into 40 each ,among which one group receives probiotics and other group receives probiotics along with simethicone ,done in OPD basis by using wessels criteria and considering my inclusion and exclusion criteria,i will perform the study and give treatment for 7 days and follow upon 14th and 28th day to asses the infantile colic status in that age group.It helps in mainly assesing the duration ,frequency of cry and care giver satisfaction. |