| CTRI Number |
CTRI/2024/12/078094 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to evaluate the efficacy of probiotic in infantile colic symptom relief |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-controlled study to evaluate the efficacy of probiotic CECT 7347 in infantile colic symptom relief |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ADM/240201/BLC/IC Ver No: 1.1 Date: 03rd October , 2024 |
Protocol Number |
| NCT05432479 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Ghosh |
| Designation |
Assistant Manager-Clinical Operations |
| Affiliation |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8097572024 |
| Fax |
|
| Email |
sonali.g@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai
–400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link
Road, Andheri West Mumbai –400053, Maharashtra, India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
United States of America
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Majmudar |
Anand Multispeciality hospital |
B-tower, Sundarvan Complex, near Gowra ITI, Vadodara-390016
Vadodara
GUJARAT |
9825048446
majmudar46@gmail.com |
| Dr Vinay Bajpaye |
Atmaram Child Care Hospital |
53, Y Block, Naubasta, Kanpur, Uttar Pradesh 208011
Kanpur Nagar
UTTAR PRADESH |
8263833666
drvinayatmaram@gmail.com |
| Dr Sandip Patil |
Ayush Multispecialty Hospital |
Ayush Multispecialty Hospital,Surya Arcade, Opposite Nemane Bus Stop,Nashik,Panchavati-422003
Nashik
MAHARASHTRA |
9011518175
dr.sandipp.research@gmail.com |
| Dr Vinod Kumar Gupta |
Dr. Vinod Kumar Gupta |
Medical Care Centre and Hospital LAXMI COMPLEX, KANPUR ROAD,ALAMBAGH LUCKNOW 226012 UP State, INDIA
Lucknow
UTTAR PRADESH |
8574841562
vinodmlnmc@gmail.com |
| DrVasant Khatav |
Dr.Khatavs Mothers And Child Hospital |
First floor, Arunoday shopping centre,Market lane , borivali west, Mumbai- 400092
Mumbai
MAHARASHTRA |
8451007852
drvakhatav@gmail.com |
| DrSnehal Patil |
Jeevan Clinics |
1st, Floor, Borgaonkar avenue, Opp, sai hall, Wayle nagar, Khadakpada, kalyan west -421301
Thane
MAHARASHTRA |
9867085977
snehalpati.21@gmail.com |
| Dr Jai Krishan Mittal |
National Institute of Medical Science and Research |
Kalwad Kalan and Khurd, Rajasthan 303121
Jaipur
RAJASTHAN |
9784011957
jaikrishan2mittal@gmail.com |
| Dr Madhukar Pandey |
Pragya mother & child care hospita |
Rashmi nagar colony, Varanasi-221005, India.
Varanasi
UTTAR PRADESH |
9839439464
pandeymadukar@gmail.com |
| Dr Prashant Khandgave |
Pulse Multispeciality Hospital |
Vishwa Arcade Mumbai Bangalore Highway, Navle Bridge Vadgaon Budruk, Narhe, Pune, Maharashtra 411041
Pune
MAHARASHTRA |
9970126406
drkhandgave.pulse@gmail.com |
| DrVijay Warad |
Sai Netralay And Specialit Clinic |
Sai Netralay And Speciality Clinic, aryaneshwar park 2, near aryaneshwar temple ,ICICI bank building Pune - 411009
Pune
MAHARASHTRA |
9822436184
vijaypwarad@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics committee |
Approved |
| Central Independent Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
| Ethics Committee Atmaram Atmaram Child Care Hospital |
Not Applicable |
| Ethics Committee of Pulse Multispecialty Hospital |
Not Applicable |
| institutional Ethics committee Medical Care Center and Hospital |
Approved |
| Leelavati Ethics Committee |
Approved |
| Namaste Integrated Services |
Approved |
| National Institute of Medical Science and Research |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infantile Colic |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IP |
1 sachet (1 g dispensed in minimum 4 ml of breast or formula milk daily for 28 days |
| Comparator Agent |
Maltodextrin |
1 sachet (1 g dispensed in minimum 4 ml of breast or formula milk daily for 28 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
1.Gestational age of minimum 37+0 weeks.
2. Birth weight of minimum 2500 g.
3. Age greater than 3 weeks and less than equal to 10 weeks.
4. Confirmed infantile colic defined as:
a. Parental report of crying and/or fussing for more than equal to 3 hours per day for more than equal to 3 days per week
5. Participant informed consent form signed by parent or legal guardian.
6. Infant considered healthy following clinical examination.
7. Parents or legal guardians are willing to comply with the study procedures, and the carer of the infant can attend all 3 study visits. |
|
| ExclusionCriteria |
| Details |
1. Use of antibiotics by the infant within 2 weeks prior to screening.
2. Use of probiotic supplements from birth to enrolment (including probiotic-containing formula)
3. Use of dairy products by the infants (e.g., cow milk, goat milk, etc)
4. Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
5. Congenital disorders that, in the investigator’s opinion, would impact gastrointestinal tract 6. Evidence of infant failure to thrive, it indicates by the infant falling below the 75th percentile in weight-for-length percentile and head circumference-for-age percentiles according to WHO growth standards.
7. Known lactose or gluten intolerance
8. Known allergy to cow’s milk protein or any substances in the product or placebo
9. Known other cause of abdominal pain (i.e. pyloric stenosis)
10. Participation in any other clinical study within 90 days prior to the screening.
11. Immune-compromised participant or participant with other severe chronic disorder
12. Use of probiotic supplements by breastfeeding mother from child’s birth to enrolment
13. Use of antibiotics by breastfeeding mother within 2 weeks’ prior to screening.
14. Any parent/legal guardian who is an employee of the sponsor/study site |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of 28 days of supplementation with a probiotic product on infant crying and fussing time in infants with colic as assessed by diary records |
Screening, Randomization, Virtual Follow-up I,
End of Intervention & Virtual Follow-up II |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of 28 days’ supplementation with probiotic product on:
-Resolution of colic symptoms as assessed by diary records
-Number of bouts of infant crying & fussing as assessed by diary records
-Infant sleeping time as assessed by diary records
-Use of colic rescue medications |
Screening, Randomization, Virtual Follow-up I,
End of Intervention & Virtual Follow-up II |
Exploratory Objectives
To evaluate the effect of 28 days of supplementation with probiotic product on:
-Maternal quality of life as assessed by World Health Organization Quality of Life Brief Version (WHOQOL-BREF).
-Maternal mental health as assessed by Maternal Postpartum Quality of Life Questionnaire (MAPP-QoL).
-In addition, stool samples will be taken, & stored for optional future analyses of the following parameters (dependent upon the results of the primary/secondary parameters):
-Fecal microbiota diversity
-Fecal calprotectin |
Day 0 & Day 28 |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/12/2024 |
| Date of Study Completion (India) |
27/04/2026 |
| Date of First Enrollment (Global) |
28/12/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study is a randomized, double-blind, placebo-controlled study. Approximately 143 infants will be screened, and considering a screening failure rate of 20%, at least 114 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have not less than 40 evaluable participants after accounting for a dropout/withdrawal rate of 30%. The intervention duration for all the study participants is 28 days |