| CTRI Number |
CTRI/2024/05/066726 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Probiotics on Serum Bilirubin Levels of newborns. |
|
Scientific Title of Study
|
Effects of Lactobacillus Rhamnosus GG Supplementation in Reducing serum bilirubin in neonates after 35 weeks of gestation as compared to only breast milk. A tertiary care center based one year study- a randomized controlled trial. |
| 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 Pavitra Alva |
| Designation |
Pediatric Resident |
| Affiliation |
JNMC Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru
Nagar, KLE Hospital Road
Belgaum
Belgaum
KARNATAKA
5900010
India |
| Phone |
7045457130 |
| Fax |
|
| Email |
pavi.alva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanmaya Metgud |
| Designation |
Professor |
| Affiliation |
JNMC Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru
Nagar, KLE Hospital Road
Belgaum
Belgaum
KARNATAKA
5900010
India |
| Phone |
9845395294 |
| Fax |
|
| Email |
tanmayametgud@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavitra Alva |
| Designation |
Pediatric Resident |
| Affiliation |
JNMC Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru
Nagar, KLE Hospital Road
Belgaum
Belgaum
KARNATAKA
5900010
India |
| Phone |
7045457130 |
| Fax |
|
| Email |
pavi.alva@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital Jawaharlal Nehru Medical College KLE University Belagavi 590010 India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, KLE University Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar KLE Hospital Road, Belgaum, Karnataka, 590010 |
| 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 |
| Dr Pavitra Alva |
KLEs Dr Prabhakar Kore hospital Belagavi |
Department of Paediatrics, Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum
Belgaum
KARNATAKA |
70454-57130
pavi.alva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Newborns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control only breastmilk given to neonates |
only breastmilk given to neonates |
| Intervention |
Probiotic administered to neonates for 5 days |
probiotics will be adimnistered to new borns for a period of 5 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
6.00 Day(s) |
| Gender |
Both |
| Details |
Newborns born after 35 weeks of gestation from day 3 of life to day 6 of life |
|
| ExclusionCriteria |
| Details |
Neonate of a gestational diabetic mother.
Familial hematological disorder with signs of hemolysis.
Neonates requiring intensive care admission during first 3 days of life.
Neonates with congenital anomalies/malformations. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of lactobacillus rhamnosus gg in reducing serum bilirubin levels in neonates. |
To assess the role of lactobacillus rhamnosus gg in reducing serum bilirubin levels in neonates over a period of first 5 days of life. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 2 |
|
Date of First Enrollment (India)
|
13/05/2024 |
| 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 - NO
|
|
Brief Summary
|
Jaundice is one of the most common conditions requiring medical care in neonates. Neonatal jaundice is a very common condition and affects approximately 2.4- 15% of newborn babies during the first 2 weeks of life. A rise of serum bilirubin level above3 15 mg/dl increases susceptibility to irreversible neurodisability . Timely detection of hyperbilirubinemia and early intervention is of utmost importance to prevent long term neurodisability. Sufficient feeding with sunlight exposure is associated with reduced risk of hyperbilirubinemia. It is plausible that early administration of probiotics in neonates can prevent neonatal hyperbilirubinemia as the new born intestinal microflora is not fully formed in the first days of life and this cause increase in bilirubin enterohepatic circulation. Probiotics reduce the enterohepatic circulation of bilirubin by reducing the activity of beta-glucoronidase by thus promoting its excreation. Lactobacillus rhamnosus GG is considered safe by the united states FDA and the most sought after probiotic used worldwide. The use of probiotics in neonates is well established in necrotising enterocolitis There have been limited number of studies in assessing its role in reducing the incidence of neonatal hyperbilirubinemia. Most number of interventional studies have been done in intensive care set up assessing the use of probiotics as a supplement to phototherapy in preterm neonates. Probiotic supplementation can also aid in maturation of the underdeveloped gut flora reducing the incidence of gastroenteritis and promoting the growth of healthy gut flora. There is a lacuna in finding the role of probiotics as a prophylaxis to reduce serum bilirubin level in term neonates. This study will help to decipher the effectiveness of probiotics in reducing serum bilirubin levels thus reducing the need for phototherapy which leads to prolongation of hospital stay and separation from mother. |