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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028295
Receipt No. R000032288
Scientific Title Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Date of disclosure of the study information 2017/09/01
Last modified on 2017/07/20

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Basic information
Public title Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Acronym Single-Site, Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Scientific Title Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.
Scientific Title:Acronym 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
1st name
Middle name
Last name Manabu Kuroda
Organization Amano Enzyme Inc.
Division name Medical Enzyme Division R&D
Zip code
Address 1-6 Technoplaza,Kakamigahara-shi,Gifu
TEL 058-379-1221
Email manabu_kuroda@amano-enzyme.com

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Kuroda
Organization Amano Enzyme Inc.
Division name Medical Enzyme Division R&D
Zip code
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)

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 Progressive Medical Research(Florida, USA)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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 Completed
Date of protocol fixation
2013 Year 05 Month 03 Day
Date of IRB
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

Other
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

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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