Study of Enzyme Supplements to Treat Celiac Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Heim Pal Children's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Heim Pal Children's Hospital
Collaborator:
Stanford University
Information provided by:
Heim Pal Children's Hospital
ClinicalTrials.gov Identifier:
NCT00962182
First received: August 18, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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Purpose
The purpose of this study is to examine whether a cocktail of two common food-grade enzyme supplements leads to decrease of serum activity markers in celiac disease patients insufficiently treated by previous gluten exclusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Celiac Disease Dermatitis Herpetiformis |
Drug: STAN1 Drug: Placebo enzyme Drug: STAN1+gluten |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity |
Resource links provided by NLM:
Further study details as provided by Heim Pal Children's Hospital:
Primary Outcome Measures:
- Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Negative seroconversion or drop of at least two dilution steps in the EMA test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Negative conversion for celiac antibodies in the blood by the rapid test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in symptoms or rash (if any) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Favorable changes in morphometry in small bowel biopsy specimens [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Pre-intervention placebo phase
Placebo enzyme for 4 weeks
|
Drug: Placebo enzyme
3-4 capsules/day at meals
|
|
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
|
Detailed Description:
Celiac disease is genetically determined abnormal immune response to gluten, a component of wheat, rye and barley proteins that cause damage to the villous structure in the small bowel. The active disease is characterized by the induction of gluten-dependent autoantibodies to transglutaminase type-2, which are sensitive and specific non-invasive markers of gluten-sensitivity. Gluten-free diet normally leads to clearance of antibodies from serum in 6-12 months. Persistent seropositivity is a problem in patients who only incompletely exclude gluten or frequently transgress the diet. In such cases, damage of the small bowel may persist and complications may occur at higher frequency. The central hypothesis to be tested is that enzyme treatment designed to degrade a certain amount of gluten before absorption in the gastrointestinal tract will lead to a clinically meaningful decrease in auto-antibody levels in these patients.
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962182
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962182
Contacts
| Contact: Ilma Korponay-Szabo, M.D., Ph.D. | +36-1-459-9192 | Ilma.Korponay-Szabo@uta.fi | |
| Contact: Judit Tumpek, M.D. | +36-1-459-9100 ext 1334 | tumpek.judit@freemail.hu |
Locations
| Hungary | |
| Heim Pal Children's Hospital | Recruiting |
| Budapest, Hungary, 1089 | |
| Contact: Ilma Korponay-Szabo, PhD +36-1-459-9192 Ilma.Korponay-Szabo@uta.fi | |
| Contact: Judit Tumpek +36-1-459-9100 ext 1334 tumpek.judit@freemail.hu | |
| Principal Investigator: Ilma Korponay-Szabo, M.D., Ph.D. | |
| Sub-Investigator: Judit Tumpek, M.D. | |
| University of Debrecen | Recruiting |
| Debrecen, Hungary, H-4032 | |
| Contact: Ilma Korponay-Szabo, M.D., Ph.D. +36-52-255-603 ext 56168 Ilma.Korponay-Szabo@uta.fi | |
| Contact: Eva Nemes, M.D., Ph.D. +36-52-255-603 ext 56168 enemes@dote.hu | |
| Principal Investigator: Ilma Korponay-Szabo, M.D., Ph.D | |
| Sub-Investigator: Judit Tumpek, M.D. | |
| Sub-Investigator: Eva Nemes, M.D., Ph.D. | |
Sponsors and Collaborators
Heim Pal Children's Hospital
Stanford University
Investigators
| Study Director: | Ilma Korponay-Szabo, M.D., Ph.D. | Heim Pal Children's Hospital |
More Information
No publications provided
| Responsible Party: | Ilma Korponay-Szabo, associate professor, Heim Pal Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00962182 History of Changes |
| Other Study ID Numbers: | HP-03 |
| Study First Received: | August 18, 2009 |
| Last Updated: | August 18, 2009 |
| Health Authority: | Hungary: National Institute for Food and Nutrition Science |
Keywords provided by Heim Pal Children's Hospital:
|
celiac disease transglutaminase antibody |
Additional relevant MeSH terms:
|
Celiac Disease Dermatitis Dermatitis Herpetiformis Autoimmune Diseases Digestive System Diseases Gastrointestinal Diseases |
Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Skin Diseases Skin Diseases, Vesiculobullous |
ClinicalTrials.gov processed this record on February 26, 2015