UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050167 |
|---|---|
| Receipt number | R000057040 |
| Scientific Title | The effect of synbiotics on pathophysiology in patients with chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/28 19:33:10 |
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Basic information
Public title
The effect of synbiotics on pathophysiology in patients with chronic obstructive pulmonary disease.
Acronym
The effect of synbiotics on pathophysiology in patients with chronic obstructive pulmonary disease.
Scientific Title
The effect of synbiotics on pathophysiology in patients with chronic obstructive pulmonary disease.
Scientific Title:Acronym
The effect of synbiotics on pathophysiology in patients with chronic obstructive pulmonary disease.
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of the administration of synbiotics on gut microbiota, systemic inflammation, subjective symptoms, pulmonary function and nutritional status in stable patients with COPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
circulating inflammatory mediators
Key secondary outcomes
gut microbiota
subjective symptoms
pulmonary function
nutritional status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
GFO(Otsuka Pharmaceutical Factory, Inc.)15g 3times/day + bifidobacteria powder(CLINICO, Co., Ltd.)2g once/day:0ral administration for 6months
Interventions/Control_2
bifidobacteria powder(CLINICO, Co., Ltd.)2g once/day:0ral administration for 6months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD patients in stable condition for more than 3 months.
patients agreed to participate this study
patients without dysphagia
Key exclusion criteria
patients with dysphagia
patients with severe metabolic disease, cardiovascular disease, hepatic disease, and renal disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nara Medical University
Division name
Division of Nutritional management
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
noriy@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nara Medical University
Division name
Division of Nutritional Management
Zip code
634-8522
Address
840 Shijocho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
noriy@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Masanori Yoshikawa
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
noriy@naramed-u.ac.jp
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
| 2023 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057040
| 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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| Registered date | File name |
