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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030449
Receipt No. 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

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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
Email 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
Email shige-taguchi@kkd.biglobe.ne.jp

Sponsor
Institute Kands R&D Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034766

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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