UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043819 |
|---|---|
| Receipt number | R000033618 |
| Scientific Title | The development of the cure of the functional intestinal disorder based on the differences of gut microbiota in aged patients |
| Date of disclosure of the study information | 2021/04/03 |
| Last modified on | 2021/04/02 14:13:42 |
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Basic information
Public title
The development of the cure of the functional intestinal disorder based on the differences of gut microbiota in aged patients
Acronym
The cure of the functional intestinal disorder and gut microbiota in aged patients
Scientific Title
The development of the cure of the functional intestinal disorder based on the differences of gut microbiota in aged patients
Scientific Title:Acronym
The cure of the functional intestinal disorder and gut microbiota in aged patients
Region
| Japan |
Condition
Condition
Functional intestinal disorder
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the relation between the dysporia and the intestinal bacterial flora, and its appropriate cures in aged patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison about respoded rate of the improvement of the voluntary evacuation
Key secondary outcomes
The degree of improvement of subjective symptoms based on functional intestinal disorder except for the improvement of the voluntary evacuation and the examination of the change in the intestinal bacterial flora
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Laxative+Lactobacillary preparation/(Interventions)
Interventions/Control_2
Laxative only/(Control)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient of 65 years old and over whose organic disease in the large intestine is excluded with a colonoscope, and also who the consent of the commitment of the specimen could be obtained by in bio-bank
Key exclusion criteria
The patient who can't obtain consent to the research participation,and
who a physician in charge judges an inadequacy are excluded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshihirio |
| Middle name | |
| Last name | Matsuura |
Organization
National Center for Geriatrics and Gerontology
Division name
Division of Gastroenterology
Zip code
4748511
Address
7-430 Morioka-cho Obu Aichi Japan
TEL
0562-46-2311
matsuura@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Geriatrics and Gerontology
Division name
Division of Gastroenterology
Zip code
474-8511
Address
7-430 Morioka-cho Obu Aichi Japan
TEL
0562-46-2311
Homepage URL
yosiko@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562462311
yaday@ncgg.go.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
国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Whether intervention was conducted using only oral constipation-improving drugs or laxatives combined with probiotics, it was extremely effective in improving spontaneous defecation, the Bristol score, and symptoms of patients. There was no clear difference in the final validation results after 12 weeks between Groups A and B, however, the probiotic combination group (B) experienced early improvement in constipation.
Results date posted
| 2021 | Year | 04 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Not all analyzes of the gut microbiota have been completed
Date of the first journal publication of results
Baseline Characteristics
chronic constipation patients who were 65 years or older and were treated at the Department of Gastroenterology, National Center for Geriatrics and Gerontology.
Participant flow
According to International diagnostic criteria by Rome IV10 chronic constipation was defined from the perspective of constipation symptoms and their persistence.patients were assigned with block randomization by the lottery method to either the group given only laxatives (Group A) or the group given laxatives combined with probiotics (Group B).
Adverse events
No adverse events
Outcome measures
As the primary endpoint, the degree of improvement in spontaneous defecation was investigated for twelve weeks from the time of intervention. Patients self-reported their defecation status by recording the number of defecations per week, the Bristol score as stool properties, the degree of improvement in subjective symptoms, and the properties of the stools.
Plan to share IPD
Group A included 13 cases, and Group B included 17 cases
IPD sharing Plan description
More women and patients with a long average history of constipation comprised Group B. However, no significant difference was observed between basic patient information, including nutritional status, ADL, and age distribution
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2021 | Year | 04 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033618
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