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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048048
Receipt No. R000054756
Scientific Title Effectiveness of Lactobacillus rhamnosus (LGG) as an adjunct in the treatment of Enteric fever in Children. A Randomised Controlled Trial
Date of disclosure of the study information 2022/08/18
Last modified on 2022/06/14

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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