Non-coeliac Gluten SensitivityAN-PEP-03NCT02060864
Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals
A study testing AN-PEP in people with Non-coeliac Gluten Sensitivity, run by DSM Food Specialties at 1 site in Sweden.
Trial summary
In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-coeliac Gluten Sensitivity
- What is being tested?
- AN-PEP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/female
- Age ≥18 but <70 yr
- Females: Hormonal contraceptive treatment
- Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
- Subject has read and understood the information provided on the study and given written informed consent
Who cannot join
- Coeliac disease serology while consuming gluten (serological test for tissue transglutaminase IgA antibodies and total IgA antibodies)
- Wheat allergy (serological test for wheat protein IgE antibodies)
- Medication or medical condition that affects gastric emptying or secretion
- Females: Pregnancy or breast-feeding
- Inability to swallow the gastroduodenal feeding tube
- Any medical condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
- Any condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.
- Conditions
- Non-coeliac Gluten Sensitivity
- Being tested
- AN-PEP, Placebo
- Keywords
- enzyme, gluten, food intolerance
- Medical subject headings
- Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN-PEPDietary supplement
Also called Aspergillus Niger-Prolyl Endopeptidase
Two pills are consumed in the morning with a breakfast
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 Placebo pills Receives: Dietary Supplement: Placebo |
| AN-PEP 80.000 PPI | Experimental | 1 pill AN-PEP 80.000 PPI and 1 pill Placebo. Receives: Dietary Supplement: AN-PEP |
| AN-PEP 160.000 PPI | Experimental | 2 pills AN-PEP 80.000 PPI Receives: Dietary Supplement: AN-PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 160.000 PPI AN-PEP on duodenal gluten
Effect of AN-PEP (160.000 PPI) on gluten degradation based on amount of gluten detected in the duodenum compared with placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
Measured: 3-hour
Secondary outcomes (7)
Effect of 160.000 PPI AN-PEP on gastric gluten
Effect of AN-PEP (160.000 PPI) on gluten degradation based on amount of gluten detected in the stomach compared with placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
Measured: 3-hour
Effect of 80.000 PPI AN-PEP on duodenal gluten
Effect of AN-PEP (80.000 PPI) on gluten degradation based on amount of gluten detected in the duodenum compared to placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
Measured: 3-hour
Effect of 80.000 PPI AN-PEP on gastric gluten AUC
Effect of AN-PEP (80.000 PPI) on gluten degradation based on amount of gluten detected in the stomach compared to placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
Measured: 3-hour
Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (160.000 PPI) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the duodenum compared with placebo over 180 min using AUC.
Measured: 3-hour
Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (160.000 PPI) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the stomach compared with placebo over 180 min using AUC.
Measured: 3-hour
Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (80.000 PPI) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the duodenum compared with placebo over 180 min using AUC.
Measured: 3-hour
Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (low and high dose) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the stomach compared with placebo over 180 min using AUC.
Measured: 3-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-coeliac Gluten SensitivityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- DSM Food Specialties
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060864
- Sponsor's protocol ID
- AN-PEP-03
- Acronym
- AN-PEP-03
- Status last verified
- Aug 2015
- First submitted
- 11 Feb 2014
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
- ClinicalTrials.gov ID
- NCT02060864
- Acronym / sponsor ID
- AN-PEP-03 / AN-PEP-03
- Conditions
- Non-coeliac Gluten Sensitivity
- Keywords
- enzyme, gluten, food intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- DSM Food SpecialtiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Feb 2014 (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.
In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 Placebo pills |
| AN-PEP 80.000 PPI | Experimental | Dietary Supplement: AN-PEP1 pill AN-PEP 80.000 PPI and 1 pill Placebo. |
| AN-PEP 160.000 PPI | Experimental | Dietary Supplement: AN-PEP2 pills AN-PEP 80.000 PPI |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male/female
- Age ≥18 but <70 yr
- Females: Hormonal contraceptive treatment
- Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
- Subject has read and understood the information provided on the study and given written informed consent
Key exclusion criteria (7 listed)
- Coeliac disease serology while consuming gluten (serological test for tissue transglutaminase IgA antibodies and total IgA antibodies)
- Wheat allergy (serological test for wheat protein IgE antibodies)
- Medication or medical condition that affects gastric emptying or secretion
- Females: Pregnancy or breast-feeding
- Inability to swallow the gastroduodenal feeding tube
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 |
|---|---|---|
| AN-PEPAlso: Aspergillus Niger-Prolyl EndopeptidaseTwo pills are consumed in the morning with a breakfast | Dietary supplement | AN-PEP 160.000 PPI, AN-PEP 80.000 PPI |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Effect of 160.000 PPI AN-PEP on duodenal gluten
Time frame: 3-hour
Effect of AN-PEP (160.000 PPI) on gluten degradation based on amount of gluten detected in the duodenum compared with placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
7 secondary outcomes
Effect of 160.000 PPI AN-PEP on gastric gluten
Time frame: 3-hour
Effect of 80.000 PPI AN-PEP on duodenal gluten
Time frame: 3-hour
Effect of 80.000 PPI AN-PEP on gastric gluten AUC
Time frame: 3-hour
Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction
Time frame: 3-hour
Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction
Time frame: 3-hour
Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction
Time frame: 3-hour
Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction
Time frame: 3-hour
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 28 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AN-PEP in people with Non-coeliac Gluten Sensitivity, run by DSM Food Specialties at 1 site in Sweden.
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 5 inclusion and 7 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 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
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?
Effect of 160.000 PPI AN-PEP on duodenal gluten (time frame: 3-hour). 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 28 Aug 2015.