UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015044 |
|---|---|
| Receipt number | 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 17:29:14 |
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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
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
ichimura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Graduate school of Medical Sciences, Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017503
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