UMIN-CTR Clinical Trial

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