Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.

Single-Site,Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms. - Single-Site, Single Blind, Placebo-Controlled Study of Gluten Digesting Enzymes as Modulators of Gluten Intolerance Symptoms.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028295

Enrollment

Registered

2017-09-01

Start date

2014-01-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gluten intolerance

Interventions

Control : Placebo Three times a day 2 weeks repeated intake Active: Gluten digestion enzymes Three times a day 2 weeks repeated intake

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gluten intolerance patient

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Analysis of gluten intolerance symptoms after 2 weeks	—

Secondary

Measure	Time frame
1.Safety 2.Biomarkers(RANTES,TNF-alpha,IL-8) 3.Gluten intolerance symptoms(Questionnaire)	—

Countries

North America

Contacts

Public ContactManabu Kuroda

Amano Enzyme Inc. Medical Enzyme Division R&D

manabu_kuroda@amano-enzyme.com058-379-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026