UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Keiko Seki
Organization	Medical Corporation foundation Souyukai
Division name	Takatobashi Clinic
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	Shigeru Taguchi
Organization	Kands R&D Corporation
Division name	Bord director
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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
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