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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015044
Receipt No. R000017503
Scientific Title The prospective pilot trial for evaluating the effects of probiotics on the clinical course of the HIV-1-infected children on ART and ART naive at National Hospital of Pediatrics in Hanoi, Vietnam
Date of disclosure of the study information 2014/09/03
Last modified on 2014/09/03

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Basic information
Public title The prospective pilot trial for evaluating the effects of probiotics on the clinical course of the HIV-1-infected children on ART and ART naive at National Hospital of Pediatrics in Hanoi, Vietnam
Acronym The efficacy of probiotics on the immune status of HIV-infected-children
Scientific Title The prospective pilot trial for evaluating the effects of probiotics on the clinical course of the HIV-1-infected children on ART and ART naive at National Hospital of Pediatrics in Hanoi, Vietnam
Scientific Title:Acronym The efficacy of probiotics on the immune status of HIV-infected-children
Region
Asia(except Japan)

Condition
Condition Human immunodeficiency virus type 1 (HIV-1) infection
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To elucidate the status of intestinal bacterial translocation, immune activation, and systemic inflammation in HIV-1-infected children.
2. To evaluate the effect of probiotics, Lactobaccilus casei strain Shirota (LcS), on the intestinal microbial translocation and the following chronic immune activation and systemic inflammation, by comparing the condition before and after the ingestion of LcS among on Antiretroviral treatment (ART)- and ART-naive HIV-1-infected children.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The concentration of the plasma 16SrDNA/RNA before and after the ingestion of LCS
Key secondary outcomes - The concentration of the plasma soluble CD14
- The plasma HIV load
- The plasma CD4 count
- The concentration of the plasma cytokines
- The profile of the CD25/CD4 ratio on PBMC

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Group 1: HIV-1 infection (+), ART (-)
Interventions: Ingest 65ml of LcS containing substrate (Yakult), everyday for 8 weeks.
Interventions/Control_2 Group 2: HIV-1 infection (+), ART (+)
Interventions: Ingest 65ml of LcS containing substrate (Yakult), everyday for 8 weeks.
Interventions/Control_3 Group 3: HIV-1 infection (-)
Interventions: Ingest 65ml of LcS containing substrate (Yakult), everyday for 8 weeks.
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
2 years-old <=
Age-upper limit
8 years-old >=
Gender Male and Female
Key inclusion criteria - Intervention group 1 and 2:
(1) HIV-1-infected children following at National Pediatric Hospital (NHP), Hanoi, Vietnam
(2) whose guardians are informed and consent to participate in this trial.
(3) who can follow the trial protocol.
- Intervention group 3:
(1) whose guardians are informed and consent to participate in this trial.
(2) who can follow the trial protocol.
Key exclusion criteria - Intervention group 1 and 2:
(1) whose status are Acquired immune deficiency syndrome, AIDS
(2) who have symptoms of intestinal infection.
(3) who have had any treatment which might influence on her/his immune system within last eight weeks of starting to take test substance.
(4) who are allergic to milk
- Intervention group 3:
(1) who have symptoms of intestinal infection.
(2) who have had any treatment which might influence on her/his immune system within last eight weeks of starting to take test substance.
(3) who are allergic to milk
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi ICHIMURA
Organization Graduate school of Medical Sciences, Kanazawa University
Division name Department of Viral infection and International Health
Zip code
Address 13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL +81-76-265-2229
Email ichimura@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi ICHIMURA
Organization Graduate school of Medical Sciences, Kanazawa University
Division name Department of Viral infection and International Health
Zip code
Address 13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL +81-76-265-2229
Homepage URL
Email ichimura@med.kanazawa-u.ac.jp

Sponsor
Institute Graduate school of Medical Sciences, Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor - National Hospital of Pediatrics, Hanoi, Vietnam
- Yakult Central Institute for Microbiological Research
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 ベトナム国・ハノイ市国立小児病院(National Hospital of Pediatrics, Hanoi, Vietnam)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 03 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
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
2012 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2012 Year 08 Month 08 Day
Date of closure to data entry
2013 Year 03 Month 15 Day
Date trial data considered complete
2014 Year 01 Month 30 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 03 Day
Last modified on
2014 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017503

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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