UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028295 |
|---|---|
| Receipt number | 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 10:06:18 |
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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
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
manabu_kuroda@amano-enzyme.com
Sponsor or person
Institute
Amano Enzyme Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032288
