UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030449 |
|---|---|
| Receipt number | R000034766 |
| Scientific Title | Dose finding and constipation effect by the intake of a newly oligomeric condensation of lactic acids, GL-1708: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2018/06/26 07:31:46 |
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Basic information
Public title
Dose finding and constipation effect by the intake of a newly oligomeric condensation of lactic acids, GL-1708: a randomized, double blind, placebo-controlled study
Acronym
Dose finding and constipation effect by the intake of a newly oligomeric condensation of lactic acids, LAC
Scientific Title
Dose finding and constipation effect by the intake of a newly oligomeric condensation of lactic acids, GL-1708: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Dose finding and constipation effect by the intake of a newly oligomeric condensation of lactic acids, LAC
Region
| Japan |
Condition
Condition
Healty adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
This study aim to evaluate the effects of ingestion of food containing LAC for 4 weeks on constipation effect in subjects with bowel movement slower.
Key secondary outcomes
Efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of capsules containing a newly oligo lactic acids, LAC, daily for consecutive 4 weeks
Interventions/Control_2
Ingestion of placebo(capsules without a newly oligo lactic acids) daily for consecutive 4 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) An age 30 years or older and up to 60 years, the age shall be the date of informed consent acquisition)
2) Subjects with constipation (functional constipation) whose stool frequency is 10 or less in 2 weeks
3) Subjects who are judged as suitable for the study by the investigotor
4) Those who received sufficient explanation about the purpose of this study and agree to subject in an informed consent
Key exclusion criteria
1) A medical history of severe disorders, which affects absorption, metabolism, excretion in the digestive tract, heart, liver, thyroid gland and kidney, or those subjects who have difficulty in participating in this study of their past medical history
2) Gastrectomy, gastrointestinal sutures, who have major surgery history affects absorption in the gastrointestinal tract site such as intestinal resection
3) Those who have hypersensitivity to drugs or idiosyncrasies
4) Those who have ever suffered from a physical disorder by ingesting a commercially available supplement
5) Alcohol or drug addicts
6) Pregnancy or women of childbearing potential, who wish to become pregnant during lactation or test period
7) Those who are participating in other clinical trials at the start of this study
8) Those who participated in clinical trials of medicines within 16 weeks before this study, or human examination of health food within 8 weeks
9) Those who took medical prescription medicines such as an intestinal tract or the like, which have an effect on constipation treatment etc. within one week before the start of the study
10) Those who collected 400 mL or more of whole blood within 12 weeks before the start of the test
11) In addition, those judged unsuitable as subjects by investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Seki |
Organization
Medical Corporation foundation Souyukai
Division name
Takatobashi Clinic
Zip code
Address
Maison Doll Takatanobaba 1st floor, 2-5-24 Takatanobaba, Shinjyuku-ku, Tokyo
TEL
03-3200-1540
kon.k@mtbank.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Taguchi |
Organization
Kands R&D Corporation
Division name
Bord director
Zip code
Address
D_Gurafoto809, 3-4, Tsurumaki, Tama-city, Toukyo
TEL
042-372-5169
Homepage URL
shige-taguchi@kkd.biglobe.ne.jp
Sponsor or person
Institute
Kands R&D Corporation
Institute
Department
Personal name
Funding Source
Organization
GLART INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人財団 綜友会 高戸橋クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 30 | 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
This study aims to evaluate the effects of ingestion of food containing LAC for 4 weeks on constipation effect in subjects with bowel movement lower
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Dose dependency
Safety
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034766
