| CTRI Number |
CTRI/2021/09/036378 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Probiotics in Infantile Colic |
|
Scientific Title of Study
|
A Prospective, Quasi Randomized Double Blind Placebo Controlled Study of L.Reuteri on Infantile Colic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahendrappa K B |
| Designation |
Professor and Head |
| Affiliation |
Adichunchanagiri Hospital and Research Centre |
| Address |
Department of Pediatrics
Adichunchanagiri Hospital and Research Centre
B.G.Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
9944802609 |
| Fax |
|
| Email |
drmahendrappakb@bgsaims.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Venkataraman |
| Designation |
Professor and Head, Department of Pharmacy Practice, Head Clinical Trials,Clinical Trial Centre |
| Affiliation |
Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri Hospital and Research Centre |
| Address |
Department of Pharmacy Practice
Room No:35
Adichunchanagiri Hospital and Research Centre
B.G.Nagara
Clinical Trial Centre
Adichunchanagiri Hospital and Research Centre
B.G.Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
9980038331 |
| Fax |
|
| Email |
rajeshvenky_research@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayanthi |
| Designation |
Manager Scientific Affairs |
| Affiliation |
Unique Biotech Limited |
| Address |
Unique Biotech Limited
Plot No.2
Phase II
Alexandria Knowledge Park Kolthur Village
Shameerpet Mandal Ranga Reddy Dist
Hyderabad
TELANGANA
500078
India |
| Phone |
|
| Fax |
|
| Email |
jayanthi@uniquebiotech.com |
|
|
Source of Monetary or Material Support
|
| Unique Biotech Limited, Plot No 2, Phase II, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy Dist, Hyderabad- 500078 |
|
|
Primary Sponsor
|
| Name |
Unique Biotech Limited |
| Address |
Unique Biotech Limited, Plot No 2, Phase II, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy Dist, Hyderabad- 500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rajesh Venkataraman |
Adichunchanagiri Hospital and Research Centre |
Department of Pediatrics
2nd Floor
Roon No 05
Adichunchanagiri Hospital and Research Centre
B.G.Nagara
Mandya
KARNATAKA |
9980038331
rajeshvenky_research@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AH & RC, Adichunchanagiri Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infantile colic |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
5 drops contains Sun flower oil, Medium chain triglycerides,Silicon di oxide, Mixed tocopherol |
| Intervention |
Probiotic Lactobacillus reuteri UBL Ru-87 |
5 drops of Lactobacillus reuteri UBL Ru-87 contains 100 million colony-forming units |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
4.00 Month(s) |
| Gender |
Both |
| Details |
1. Age: from birth to <4 months of age
2. Diagnosed with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment) according to Rome III criteria and recommended with nutritional supplementation of Lactobacillus reuteri for infantile colic by the treating physician
3. Full term infant, i.e., gestational age between 37 and 42 weeks
4. Breast fed, either exclusively
5. Birth weight ≥ 2500g
6. Apgar score more than 8 at 5 minutes at birth
7. Written informed consent from parents to share data as per protocol and adhere to routine follow up visits as required by treating physician
8. Parent(s) willing to maintain same infant feeding mode throughout study period
9. Parent(s) willingness and ability to fill in diary and questionnaires
|
|
| ExclusionCriteria |
| Details |
1. Significant co-existing illness or major medical problem, which in opinion of treating physician does not make patient suitable for participation in study
2. Any other gastrointestinal disorder
3. Failure to thrive
4. Use of antibiotics two weeks before enrollment and throughout the intervention period, for both infant and mother
5. Use of probiotics two weeks before enrollment and throughout the intervention period, for both infant (infant formula and/or supplementation) and mother
6. Use of acid suppressive therapy two weeks before enrolment and throughout the intervention period.
7. Infant receiving solid foods, such as cereals, mashed fruits or vegetable puree
8. Participation in any other interventional study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Treatment success, defined as the percentage of children achieving a reduction in the daily average crying time to less than 3 hrs., and the duration of crying (minutes per day) at 7,14, 21 and 28 days after randomization with reference to baseline (recorded daily by parent as well) |
Visit 1 Screening and baseline assessment.
Treatment Initiation (day 0)
Visit 2 Follow-up 1 (Day 07 ± 2 days)
Visit 3 Follow-up 2 (Day 14 ± 2 days)
Visit 4 Follow-up 3 (Day 21 ± 2 days)
Visit 5 End of study (Day 28 ± 2 days)
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
a. The percentage of children achieving a reduction in the daily average crying time defined as the percentage of children achieving a reduction in the daily average crying time ≥50% (Timeline on day 28 with reference to baseline)
b. Persistence of infantile colic after the intervention (Timeline on day 28 with reference to baseline)
c. Parental perceptions of colic severity; & parental/ family quality of life. To assess infantile colic (parental) a 10-cm visual analog scale (VAS) will be used. The possible scores ranged from0 to 10. For the parent’s perception of colic severity, 0 indicates no pain & 10 indicated the worst pain. For the parental/family quality of life, 0 indicates no effect & 10 indicates a very good effect. Parents will be instructed how to use the VAS scale prior to the study (Timeline baseline/Day 0, Day 7, Day 14, Day 21 & Day 28).
d. Analysis of gut microbiota from fecal samples at baseline & EOT |
Visit 1 Screening & baseline assessment.
Treatment Initiation (day 0)
Visit 2 Follow-up 1 (Day 07 ± 2 days)
Visit 3 Follow-up 2 (Day 14 ± 2 days)
Visit 4 Follow-up 3 (Day 21 ± 2 days)
Visit 5 End of study (Day 28 ± 2 days)
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| Date of Study Completion (India) |
22/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to evaluate the effect of probiotic (Lactobacillus reuteri UBL Ru-87) in the treatment of infantile colic and to assess the recovery of gut microbiota dysbiosis with probiotic use. Considering the inclusion and exclusion criteria, all infants who had a diagnosis of infantile colic according to Rome III criteria: episodes of crying lasting more than 3 h a day, for 3 or more days in 1 week prior to eligibility assessment will be enrolled to the randomized double-blind, placebo-controlled study. Efficacy of the formulation will be tested for treating infantile colic.The percentage of children achieving a reduction in the daily average crying time to less than 3 hrs., and the duration of crying (minutes per day) at 7,14, 21 and 28 days after randomization with reference to baseline (recorded daily by parent as well) will be considered as treatment success. |