UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048048 |
|---|---|
| Receipt number | 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 00:13:36 |
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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
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
paedesic@gmail.com
Sponsor or person
Institute
ESIC MEDICAL COLLEGE AND PGIMSR
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054756
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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