UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054755 |
|---|---|
| Receipt number | R000062546 |
| Scientific Title | A study of the efficacy and acceptability of synbiotics in bowel preparation before colonoscopy. |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/06/25 20:51:20 |
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Basic information
Public title
The effect of symbiotics in bowel preparation before colonoscopy
Acronym
Symbiotics for colonoscopy
Scientific Title
A study of the efficacy and acceptability of synbiotics in bowel preparation before colonoscopy.
Scientific Title:Acronym
Synbiotics for bowel preparation before colonoscopy.
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the administration of synbiotics can reduce the amount of laxative taken in bowel preparation before colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the reduction of Moviprep dose, which is used as the standard bowel preparation method before colonoscopy, by pre-consumption of synbiotics from 1 day before the colonoscopy until waking up on the day of the examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
On the day before the colonoscopy, 3 sets of Synplotec should be taken after each meal, and on the day of the examination, 3 sets should be taken upon awakening.
Interventions/Control_2
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for colonoscopy
Key exclusion criteria
Patients allergic to milk, etc.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sugimura |
Organization
SANO Hospital
Division name
Gastrointestinal Center
Zip code
655-0031
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
TEL
+81-78-785-1000
n-sugimura@sano-hospital.or.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Sugimura |
Organization
SANO Hospital
Division name
Gastrointestinal Center
Zip code
655-0031
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
TEL
+81-78-785-1000
Homepage URL
n-sugimura@sano-hospital.or.jp
Sponsor or person
Institute
SANO Hospital
Institute
Department
Personal name
Funding Source
Organization
SANO Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SANO Hospital
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
Tel
+81-78-785-1000
n-sugimura@sano-hospital.or.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
| 2024 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062546
