Study of Enzyme Supplements to Treat Celiac Disease
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ClinicalTrials.gov Identifier: NCT00962182 |
Recruitment Status
:
Completed
First Posted
: August 19, 2009
Last Update Posted
: March 6, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Celiac Disease Dermatitis Herpetiformis | Drug: STAN1 Drug: Placebo enzyme Drug: STAN1+gluten | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Enzyme treatment
Enzyme for 12 weeks
|
Drug: STAN1
3-4 capsules/day at meals
|
Placebo Comparator: Placebo control
Placebo enzyme for 12 weeks
|
Drug: Placebo enzyme
3-4 capsules/day at meals
|
Experimental: Enzyme + gluten
Enzyme and 500 mg gluten b.i.d. for 12 weeks
|
Drug: STAN1+gluten
3-4 capsules/day at meals plus 500 mg gluten b.i.d
|
- Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA [ Time Frame: 12 weeks ]
- Negative seroconversion or drop of at least two dilution steps in the EMA test [ Time Frame: 12 weeks ]
- Negative conversion for celiac antibodies in the blood by the rapid test [ Time Frame: 12 weeks ]
- Change in symptoms or rash (if any) [ Time Frame: 12 weeks ]
- Favorable changes in morphometry in small bowel biopsy specimens [ Time Frame: 28 weeks ]

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Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Celiac disease diagnosed by small intestinal biopsy
- More than 12 months elapsed since initial diagnosis and start of the dietary treatment
- Evidence for ongoing active disease as verified by seropositivity or dermatitis herpetiformis rash
- Subject agrees to follow a gluten-free diet
Exclusion Criteria:
- Other gastrointestinal or hepatic disease besides celiac disease
- Selective IgA deficiency
- Use of dapsone or diaphenylsulfone
- Pregnancy and breast-feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962182
Hungary | |
Heim Pal Children's Hospital | |
Budapest, Hungary, 1089 | |
University of Debrecen | |
Debrecen, Hungary, H-4032 |
Study Director: | Ilma Korponay-Szabo, M.D., Ph.D. | Heim Pal Children's Hospital |
Responsible Party: | Ilma R Korponay-Szabo, Professor, Heim Pal Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00962182 History of Changes |
Other Study ID Numbers: |
HP-03 |
First Posted: | August 19, 2009 Key Record Dates |
Last Update Posted: | March 6, 2018 |
Last Verified: | March 2018 |
Keywords provided by Ilma R Korponay-Szabo, Heim Pal Children's Hospital:
celiac disease transglutaminase antibody |
Additional relevant MeSH terms:
Celiac Disease Dermatitis Dermatitis Herpetiformis Skin Diseases Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases Skin Diseases, Vesiculobullous Autoimmune Diseases Immune System Diseases |