UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Lactobacillus rhamnosus (LGG) as an adjunct in the treatment of Enteric fever in Children. A Randomised Controlled Trial
Acronym	LGG Lactobacillus rhamnosus GG
Scientific Title	Effectiveness of Lactobacillus rhamnosus (LGG) as an adjunct in the treatment of Enteric fever in Children. A Randomised Controlled Trial
Scientific Title:Acronym	LGG Lactobacillus rhamnosus GG
Region	Asia(except Japan)

Condition
Condition	enteric fever
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effectiveness of Lactobacillus rhamnosus GG (LGG), as an adjunct with intravenous ceftriaxone, in comparison to a placebo on: i. Defervescence in children with Enteric fever. ii. Resolution of toxemia in children with Enteric fever
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defervescence in children with Enteric fever.
Key secondary outcomes	Resolution of toxemia in children with Enteric fever

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The intervention group will receive Inj. Ceftriaxone (75 mg/kg/day in 2 divided doses for 7days) and LGG (probiotic) 3x109 CFU in a blinded powdered sachet once daily for 7days.
Interventions/Control_2	The comparison group will receive Inj. Ceftriaxone (75 mg/kg/day in 2 divided doses for 7days) and placebo in a blinded powdered sachet once daily for 7days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Children admitted to the paediatric ward with fever more than 100.4 degree celcius and Salmonella typhi or paratyphi grown in blood culture or Blood widal suggestive of Enteric fever. antigen titre more than 1in 160 or Four-fold rise in titre of blood widal witha minimum gap of 1 week between 2 samples.
Key exclusion criteria	Those who do not consent or assent Children who are critically ill Immuno-compromised children Children with enteric fever with no response to IV ceftriaxone even after 10 days of therapy
Target sample size	56

Research contact person
Name of lead principal investigator	1st name RAMYA Middle name Last name RAJAMANICKAM
Organization	ESIC MEDICAL COLLEGE AND PGIMSR
Division name	MEDICAL COLLEGE
Zip code	600078
Address	ESIC HOSPITAL AND MEDICAL COLLEGE, K.K NAGAR, CHENNAI-78
TEL	044-24748959
Email	deanmc-kkn.tn@esic.nic.in

Public contact
Name of contact person	1st name Aparna Middle name Last name Jayaraman
Organization	ESIC MEDICAL COLLEGE AND PGIMSR
Division name	MEDICAL COLLEGE
Zip code	600078
Address	ESIC HOSPITAL AND MEDICAL COLLEGE, K.K NAGAR, CHENNAI-78
TEL	044-24748959
Homepage URL
Email	paedesic@gmail.com

Sponsor
Institute	ESIC MEDICAL COLLEGE AND PGIMSR
Institute
Department

Funding Source
Organization	NONE
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ESIC MEDICAL COLLEGE AND PGIMSR- INSTITUTIONAL ETHICS COMMITTEE
Address	ESIC HOSPITAL AND MEDICAL COLLEGE, K.K NAGAR, CHENNAI-78
Tel	044-24748959
Email	iec.esic.kkn@gmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	56
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 03 Month 24 Day
Date of IRB	2019 Year 05 Month 15 Day
Anticipated trial start date	2019 Year 05 Month 30 Day
Last follow-up date	2022 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 14 Day
Last modified on	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054756