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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043819
Receipt No. 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

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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
Email 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
Email yosiko@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033618

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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