Celiac DiseasePhase 1/2NCT00962182
Study of Enzyme Supplements to Treat Celiac Disease
A Phase 1/2 study testing STAN1 and STAN1+gluten in people with Celiac Disease and Dermatitis Herpetiformis, run by Heim Pal Children's Hospital at 2 sites in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Celiac Disease, Dermatitis Herpetiformis
- What is being tested?
- STAN1 and STAN1+gluten
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesHungary
- Study dates
- Aug 2008to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other gastrointestinal or hepatic disease besides celiac disease
- Selective IgA deficiency
- Use of dapsone or diaphenylsulfone
- Pregnancy and breast-feeding
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Heim Pal Children's Hospital
Budapest, 1089
University of Debrecen
Debrecen, H-4032
About this study
Official title: Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
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.
Read the 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.
- Conditions
- Celiac Disease, Dermatitis Herpetiformis
- Being tested
- STAN1, Placebo enzyme, STAN1+gluten
- Keywords
- celiac disease, transglutaminase antibody
- Medical subject headings
- Celiac Disease, Dermatitis Herpetiformis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAN1Drug
3-4 capsules/day at meals
Placebo enzymeDrug
3-4 capsules/day at meals
STAN1+glutenDrug
3-4 capsules/day at meals plus 500 mg gluten b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Enzyme treatment | Experimental | Enzyme for 12 weeks Receives: Drug: STAN1 |
| Placebo control | Placebo comparator | Placebo enzyme for 12 weeks Receives: Drug: Placebo enzyme |
| Enzyme + gluten | Experimental | Enzyme and 500 mg gluten b.i.d. for 12 weeks Receives: Drug: STAN1+gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
Measured: 12 weeks
Secondary outcomes (4)
Negative seroconversion or drop of at least two dilution steps in the EMA test
Measured: 12 weeks
Negative conversion for celiac antibodies in the blood by the rapid test
Measured: 12 weeks
Change in symptoms or rash (if any)
Measured: 12 weeks
Favorable changes in morphometry in small bowel biopsy specimens
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heim Pal Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Ilma R Korponay-Szabo, Heim Pal Children's Hospital
- Investigators
- Ilma Korponay-Szabo, M.D., Ph.D., Study director, Heim Pal Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962182
- Sponsor's protocol ID
- HP-03
- Status last verified
- Mar 2018
- First submitted
- 18 Aug 2009
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
- ClinicalTrials.gov ID
- NCT00962182
- Acronym / sponsor ID
- HP-03
- Conditions
- Celiac Disease, Dermatitis Herpetiformis
- Keywords
- celiac disease, transglutaminase antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Heim Pal Children's HospitalUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Aug 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enzyme treatment | Experimental | Drug: STAN1Enzyme for 12 weeks |
| Placebo control | Placebo comparator | Drug: Placebo enzymePlacebo enzyme for 12 weeks |
| Enzyme + gluten | Experimental | Drug: STAN1+glutenEnzyme and 500 mg gluten b.i.d. for 12 weeks |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Other gastrointestinal or hepatic disease besides celiac disease
- Selective IgA deficiency
- Use of dapsone or diaphenylsulfone
- Pregnancy and breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAN13-4 capsules/day at meals | Drug | Enzyme treatment |
| Placebo enzyme3-4 capsules/day at meals | Drug | Placebo control |
| STAN1+gluten3-4 capsules/day at meals plus 500 mg gluten b.i.d | Drug | Enzyme + gluten |
Primary outcome
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
Time frame: 12 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
Related trials for Celiac Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilma Korponay-Szabo, M.D., Ph.D. study director
Heim Pal Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STAN1 and STAN1+gluten in people with Celiac Disease and Dermatitis Herpetiformis, run by Heim Pal Children's Hospital at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.