UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Title of the study (Brief title)	Single-Site, Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Region	North America

Condition
Condition	Gluten intolerance
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and effect on gluten intolerance symptoms of gluten digesting enzymes on human.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of gluten intolerance symptoms after 2 weeks
Key secondary outcomes	1.Safety 2.Biomarkers(RANTES,TNF-alpha,IL-8) 3.Gluten intolerance symptoms(Questionnaire)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Control : Placebo Three times a day 2 weeks repeated intake
Interventions/Control_2	Active: Gluten digestion enzymes Three times a day 2 weeks repeated intake
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Gluten intolerance patient
Key exclusion criteria	1.Subjects with a diagnosis of celiac disease proven by a biopsy 2.Subjects with uncontrolled chronic health conditions such as Type I and Type II diabetes, cardiovascular disease, etc. 3. Women who are pregnant, intending to become pregnant during the study period or currently lactating. 4. Subjects with certain combinations of serum antibodies indicating the possibility of celiac disease (strongly positive for both anti-transglutaminase and anti-gliadin antibodies; see Appendix 4).
Target sample size	40

Research contact person
Name of lead principal investigator	Manabu Kuroda
Organization	Amano Enzyme Inc.
Division name	Medical Enzyme Division R&D
Address	1-6 Technoplaza,Kakamigahara-shi,Gifu
TEL	058-379-1221
Email	manabu_kuroda@amano-enzyme.com

Public contact
Name of contact person	Manabu Kuroda
Organization	Amano Enzyme Inc.
Division name	Medical Enzyme Division R&D
Address	1-6 Technoplaza,Kakamigahara-shi,Gifu
TEL	058-379-1221
Homepage URL
Email	manabu_kuroda@amano-enzyme.com

Sponsor
Institute	Amano Enzyme Inc.
Institute
Department

Funding Source
Organization	Amano Enzyme Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Amano Enzyme U.S.A Co., Ltd,
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	Progressive Medical Research(Florida, USA)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 03 Day
Anticipated trial start date	2014 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 20 Day
Last modified on	2017 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032288