Celiac DiseaseNCT03288831
Changes in Intestinal Permeability 4 Hours After Gluten Challenge
A study testing Gluten in people with Celiac Disease and Wheat Hypersensitivity, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given gluten and half will not. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Wheat Hypersensitivity, Gluten Sensitivity
- What is being tested?
- Gluten
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 30 Oct 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biopsy proven celiac disease diagnosed at least 2 years prior to recruitment
- Attest to following a gluten free diet to the best of their ability
- Quiescent symptoms on a gluten free diet
- Negative tissue transglutaminase at time of recruitment (to be collected with baseline blood work)
- A prior endoscopy with small bowel biopsies reviewed by a gastrointestinal pathologist revealing healing
- Inclusion Criteria for subjects with Non-Celiac Gluten Sensitivity:
Show all 15Show fewer
- Meet diagnostic consensus criteria as defined by Ludvigsson et al in "The Oslo definitions for coeliac disease and related terms"
- Attest to following a gluten free diet to the best of their ability
- Quiescent symptoms on a gluten free diet
- Prior negative evaluation for celiac disease (including tissue transglutaminase IgA with total IgA or small bowel biopsies)
- If subjects have had a small bowel biopsies revealing increased intraepithelial lymphocytes (IELs), they will be reviewed as a separate subgroup
- No gastrointestinal diagnosis (reflux, eosinophilic esophagitis, inflammatory bowel disease, or irritable bowel syndrome)
- No gastrointestinal symptoms (diarrhea, abdominal pain, nausea, vomiting, weight loss)
- No family history of celiac disease
- Will not be required to have a baseline biopsy
Who cannot join
- Tobacco use
- Symptomatic coronary disease
- Active, severe pulmonary disease
- Baseline oxygen requirement
- Coagulopathy (INR>1.5)
- Mastocytosis
Show all 25Show fewer
- Active H. pylori infection
- Treated celiac disease with neutrophilia or eosinophilia secondary to infection
- Diabetes (type 1 and type 2)
- Crohn's disease or Ulcerative colitis
- Microscopic colitis
- Dermatitis herpetiformis
- Gastroparesis
- Pregnant women
- Subjects exposed to the following medications during their respective time frames will be excluded:
- NSAIDs (24 hours)
- Leukotriene inhibitors (24 hours)
- Mast cell stabilizers (24 hours)
- Benzodiazepines (24 hours)
- H2 blockers (2 days)
- H1 blockers (7 days)
- Steroids (systemic or topically active within gastrointestinal tract) (30 days)
- Topical steroids (14 days)
- Intermittent (up to once weekly) tranquilizer (trazodone, doxepin) use (7 days)
- Chronic tricyclic antidepressant or tranquilizer use (trazodone, doxepin) Use of these medications will also be prohibited during the study duration (AAAAI and AAOA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Innate Response to and Changes in Intestinal Permeability 4 Hours After a Gluten Challenge in Subjects With Celiac Disease and Non Celiac Gluten Sensitivity
This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given gluten and half will not.
Read the detailed description
When a person with celiac disease is exposed to gluten, their immune system attacks their bowel and causes abdominal pain, bloating, and diarrhea. This process takes 24-72 hours to occur. Some people without celiac disease develop similar symptoms when they eat gluten or wheat. Doctors and scientists do not know what causes this sensitivity to gluten. People with celiac disease and non-celiac gluten sensitivity report symptoms within hours of being exposed to gluten. This study evaluates why this occurs by looking at changes in blood, urine, stool, and the bowel after being given gluten.
- Conditions
- Celiac Disease, Wheat Hypersensitivity, Gluten Sensitivity, Gluten Enteropathy, Immune System and Related Disorders, Duodenal Diseases
- Being tested
- Gluten, Placebo
- Keywords
- Randomized, double-blinded, placebo-controlled trial, Oral food challenge
- Medical subject headings
- Celiac Disease, Wheat Hypersensitivity, Duodenal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenDietary supplement
Six grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time.
PlaceboDietary supplement
Subjects will drink a mixture of rice water and Tang flavoring one time.
| Study group | Role | What they receive |
|---|---|---|
| Normal Subjects, Gluten Drink | Active comparator | Normal subjects will drink a solution containing 6 grams of gluten one time. Receives: Dietary Supplement: Gluten |
| Normal Subjects, Placebo Drink | Placebo comparator | Normal subjects will drink a solution without gluten one time. Receives: Dietary Supplement: Placebo |
| Celiac Subjects, Gluten Drink | Active comparator | Subjects with celiac disease will drink a solution containing 6 grams of gluten one time. Receives: Dietary Supplement: Gluten |
| Celiac Subjects, Placebo Drink | Placebo comparator | Subjects with celiac disease will drink a solution without gluten one time. Receives: Dietary Supplement: Placebo |
| Gluten Sensitivity, Gluten Drink | Active comparator | Subjects with non-celiac gluten sensitivity will drink a solution containing 6 grams of gluten one time. Receives: Dietary Supplement: Gluten |
| Gluten Sensitivity, Placebo Drink | Placebo comparator | Subjects with non-celiac gluten sensitivity will drink a solution without gluten one time. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of the Mucosal Innate Immune System after Oral Gluten Challenge
Small bowel biopsies will be assessed for markers of innate immune system activation: presence of granulocytes, granulocyte degranulation, products of degranulation, interleukins and cytokines involved in the innate immune system response, inflammatory mediators.
Measured: 4 hours
Secondary outcomes (3)
Changes in Mucosal Permeability after Oral Gluten Challenge
Mucosal permeability will be measure before and after oral gluten or placebo challenge with C13-mannitol lactulose urinary excretion testing. In addition, mucosal permeability will also be measured along the duodenum with a mucosal impedance probe.
Measured: Baseline and up to eight hours after gluten or placebo exposure
Detection of Gluten Peptides in Urine and Stool
Urine and stool samples will be assessed for the presence of gluten peptides. This will help assess how long these tests are positive after a known gluten exposure.
Measured: Baseline and up to 72 hours after gluten or placebo exposure
Rapid Onset Symptom Development after Gluten Exposure
Subjects will record the symptoms they experience after gluten or placebo exposure. The will complete a simple symptom diary every 30 minutes for the first 2 hours.
Measured: Baseline and up to 72 hours after gluten or placebo exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start10 Oct 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled oral gluten challenge
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph A. Murray, M.D., Mayo Clinic
- Investigators
- Joseph A. Murray, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288831
- Sponsor's protocol ID
- IRB 17-003596
- Status last verified
- Jun 2019
- First submitted
- 18 Sep 2017
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leffler D, Schuppan D, Pallav K, Najarian R, Goldsmith JD, Hansen J, Kabbani T, Dennis M, Kelly CP. Kinetics of the histological, serological and symptomatic responses to gluten challenge in adults with coeliac disease. Gut. 2013 Jul;62(7):996-1004. doi: 10.1136/gutjnl-2012-302196. Epub 2012 May 22.
PubMed 22619366Adriaanse MP, Tack GJ, Passos VL, Damoiseaux JG, Schreurs MW, van Wijck K, Riedl RG, Masclee AA, Buurman WA, Mulder CJ, Vreugdenhil AC. Serum I-FABP as marker for enterocyte damage in coeliac disease and its relation to villous atrophy and circulating autoantibodies. Aliment Pharmacol Ther. 2013 Feb;37(4):482-90. doi: 10.1111/apt.12194. Epub 2013 Jan 7.
PubMed 23289539Anderson RP, van Heel DA, Tye-Din JA, Barnardo M, Salio M, Jewell DP, Hill AV. T cells in peripheral blood after gluten challenge in coeliac disease. Gut. 2005 Sep;54(9):1217-23. doi: 10.1136/gut.2004.059998.
PubMed 16099789Camarca A, Radano G, Di Mase R, Terrone G, Maurano F, Auricchio S, Troncone R, Greco L, Gianfrani C. Short wheat challenge is a reproducible in-vivo assay to detect immune response to gluten. Clin Exp Immunol. 2012 Aug;169(2):129-36. doi: 10.1111/j.1365-2249.2012.04597.x.
PubMed 22774987Beitnes AC, Raki M, Brottveit M, Lundin KE, Jahnsen FL, Sollid LM. Rapid accumulation of CD14+CD11c+ dendritic cells in gut mucosa of celiac disease after in vivo gluten challenge. PLoS One. 2012;7(3):e33556. doi: 10.1371/journal.pone.0033556. Epub 2012 Mar 16.
PubMed 22438948Jansson UH, Kristiansson B, Magnusson P, Larsson L, Albertsson-Wikland K, Bjarnason R. The decrease of IGF-I, IGF-binding protein-3 and bone alkaline phosphatase isoforms during gluten challenge correlates with small intestinal inflammation in children with coeliac disease. Eur J Endocrinol. 2001 Apr;144(4):417-23. doi: 10.1530/eje.0.1440417.
PubMed 11275953Greco L, D'Adamo G, Truscelli A, Parrilli G, Mayer M, Budillon G. Intestinal permeability after single dose gluten challenge in coeliac disease. Arch Dis Child. 1991 Jul;66(7):870-2. doi: 10.1136/adc.66.7.870.
PubMed 1863103Horvath K, Nagy L, Horn G, Simon K, Csiszar K, Bodanszky H. Intestinal mast cells and neutrophil chemotactic activity of serum following a single challenge with gluten in celiac children on a gluten-free diet. J Pediatr Gastroenterol Nutr. 1989 Oct;9(3):276-80. doi: 10.1097/00005176-198910000-00003.
PubMed 2614612Kontakou M, Przemioslo RT, Sturgess RP, Limb GA, Ellis HJ, Day P, Ciclitira PJ. Cytokine mRNA expression in the mucosa of treated coeliac patients after wheat peptide challenge. Gut. 1995 Jul;37(1):52-7. doi: 10.1136/gut.37.1.52.
PubMed 7672681Strobel S, Busuttil A, Ferguson A. Human intestinal mucosal mast cells: expanded population in untreated coeliac disease. Gut. 1983 Mar;24(3):222-7. doi: 10.1136/gut.24.3.222.
PubMed 6826106Cartee AK, Choung RS, King KS, Wang S, Dzuris JL, Anderson RP, Van Dyke CT, Hinson CA, Marietta E, Katzka DA, Nehra V, Grover M, Murray JA. Plasma IL-2 and Symptoms Response after Acute Gluten Exposure in Subjects With Celiac Disease or Nonceliac Gluten Sensitivity. Am J Gastroenterol. 2022 Feb 1;117(2):319-326. doi: 10.14309/ajg.0000000000001565.
PubMed 34797778
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Innate Response to and Changes in Intestinal Permeability 4 Hours After a Gluten Challenge in Subjects With Celiac Disease and Non Celiac Gluten Sensitivity
- ClinicalTrials.gov ID
- NCT03288831
- Acronym / sponsor ID
- IRB 17-003596
- Conditions
- Celiac Disease, Wheat Hypersensitivity, Gluten Sensitivity, Gluten Enteropathy, Immune System and Related Disorders, Duodenal Diseases
- Keywords
- Randomized, double-blinded, placebo-controlled trial, Oral food challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 20 Sep 2017 (actual)
- 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.
This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given gluten and half will not.
Detailed description
When a person with celiac disease is exposed to gluten, their immune system attacks their bowel and causes abdominal pain, bloating, and diarrhea. This process takes 24-72 hours to occur. Some people without celiac disease develop similar symptoms when they eat gluten or wheat. Doctors and scientists do not know what causes this sensitivity to gluten. People with celiac disease and non-celiac gluten sensitivity report symptoms within hours of being exposed to gluten. This study evaluates why this occurs by looking at changes in blood, urine, stool, and the bowel after being given gluten.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Randomized, double-blinded, placebo-controlled oral gluten challenge
| Arm | Type | Receives |
|---|---|---|
| Normal Subjects, Gluten Drink | Active comparator | Dietary Supplement: GlutenNormal subjects will drink a solution containing 6 grams of gluten one time. |
| Normal Subjects, Placebo Drink | Placebo comparator | Dietary Supplement: PlaceboNormal subjects will drink a solution without gluten one time. |
| Celiac Subjects, Gluten Drink | Active comparator | Dietary Supplement: GlutenSubjects with celiac disease will drink a solution containing 6 grams of gluten one time. |
| Celiac Subjects, Placebo Drink | Placebo comparator | Dietary Supplement: PlaceboSubjects with celiac disease will drink a solution without gluten one time. |
| Gluten Sensitivity, Gluten Drink | Active comparator | Dietary Supplement: GlutenSubjects with non-celiac gluten sensitivity will drink a solution containing 6 grams of gluten one time. |
| Gluten Sensitivity, Placebo Drink | Placebo comparator | Dietary Supplement: PlaceboSubjects with non-celiac gluten sensitivity will drink a solution without gluten one time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy proven celiac disease diagnosed at least 2 years prior to recruitment
- Attest to following a gluten free diet to the best of their ability
- Quiescent symptoms on a gluten free diet
- Negative tissue transglutaminase at time of recruitment (to be collected with baseline blood work)
- A prior endoscopy with small bowel biopsies reviewed by a gastrointestinal pathologist revealing healing
Key exclusion criteria (25 listed)
- Tobacco use
- Symptomatic coronary disease
- Active, severe pulmonary disease
- Baseline oxygen requirement
- Coagulopathy (INR>1.5)
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 |
|---|---|---|
| GlutenSix grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time. | Dietary supplement | Celiac Subjects, Gluten Drink, Gluten Sensitivity, Gluten Drink, Normal Subjects, Gluten Drink |
| PlaceboSubjects will drink a mixture of rice water and Tang flavoring one time. | Dietary supplement | Celiac Subjects, Placebo Drink, Gluten Sensitivity, Placebo Drink, Normal Subjects, Placebo Drink |
Primary outcome
Activation of the Mucosal Innate Immune System after Oral Gluten Challenge
Time frame: 4 hours
Small bowel biopsies will be assessed for markers of innate immune system activation: presence of granulocytes, granulocyte degranulation, products of degranulation, interleukins and cytokines involved in the innate immune system response, inflammatory mediators.
3 secondary outcomes
Changes in Mucosal Permeability after Oral Gluten Challenge
Time frame: Baseline and up to eight hours after gluten or placebo exposure
Detection of Gluten Peptides in Urine and Stool
Time frame: Baseline and up to 72 hours after gluten or placebo exposure
Rapid Onset Symptom Development after Gluten Exposure
Time frame: Baseline and up to 72 hours after gluten or placebo exposure
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 7 Jun 2019.
- Background: PubMed 22619366Leffler D, Schuppan D, Pallav K, Najarian R, Goldsmith JD, Hansen J, Kabbani T, Dennis M, Kelly CP. Kinetics of the histological, serological and symptomatic responses to gluten challenge in adults with coeliac disease. Gut. 2013 Jul;62(7):996-1004. doi: 10.1136/gutjnl-2012-302196. Epub 2012 May 22.
- Background: PubMed 23289539Adriaanse MP, Tack GJ, Passos VL, Damoiseaux JG, Schreurs MW, van Wijck K, Riedl RG, Masclee AA, Buurman WA, Mulder CJ, Vreugdenhil AC. Serum I-FABP as marker for enterocyte damage in coeliac disease and its relation to villous atrophy and circulating autoantibodies. Aliment Pharmacol Ther. 2013 Feb;37(4):482-90. doi: 10.1111/apt.12194. Epub 2013 Jan 7.
- Background: PubMed 16099789Anderson RP, van Heel DA, Tye-Din JA, Barnardo M, Salio M, Jewell DP, Hill AV. T cells in peripheral blood after gluten challenge in coeliac disease. Gut. 2005 Sep;54(9):1217-23. doi: 10.1136/gut.2004.059998.
- Background: PubMed 22774987Camarca A, Radano G, Di Mase R, Terrone G, Maurano F, Auricchio S, Troncone R, Greco L, Gianfrani C. Short wheat challenge is a reproducible in-vivo assay to detect immune response to gluten. Clin Exp Immunol. 2012 Aug;169(2):129-36. doi: 10.1111/j.1365-2249.2012.04597.x.
- Background: PubMed 22438948Beitnes AC, Raki M, Brottveit M, Lundin KE, Jahnsen FL, Sollid LM. Rapid accumulation of CD14+CD11c+ dendritic cells in gut mucosa of celiac disease after in vivo gluten challenge. PLoS One. 2012;7(3):e33556. doi: 10.1371/journal.pone.0033556. Epub 2012 Mar 16.
- Background: PubMed 11275953Jansson UH, Kristiansson B, Magnusson P, Larsson L, Albertsson-Wikland K, Bjarnason R. The decrease of IGF-I, IGF-binding protein-3 and bone alkaline phosphatase isoforms during gluten challenge correlates with small intestinal inflammation in children with coeliac disease. Eur J Endocrinol. 2001 Apr;144(4):417-23. doi: 10.1530/eje.0.1440417.
- Background: PubMed 1863103Greco L, D'Adamo G, Truscelli A, Parrilli G, Mayer M, Budillon G. Intestinal permeability after single dose gluten challenge in coeliac disease. Arch Dis Child. 1991 Jul;66(7):870-2. doi: 10.1136/adc.66.7.870.
- Background: PubMed 2614612Horvath K, Nagy L, Horn G, Simon K, Csiszar K, Bodanszky H. Intestinal mast cells and neutrophil chemotactic activity of serum following a single challenge with gluten in celiac children on a gluten-free diet. J Pediatr Gastroenterol Nutr. 1989 Oct;9(3):276-80. doi: 10.1097/00005176-198910000-00003.
- Background: PubMed 7672681Kontakou M, Przemioslo RT, Sturgess RP, Limb GA, Ellis HJ, Day P, Ciclitira PJ. Cytokine mRNA expression in the mucosa of treated coeliac patients after wheat peptide challenge. Gut. 1995 Jul;37(1):52-7. doi: 10.1136/gut.37.1.52.
- Background: PubMed 6826106Strobel S, Busuttil A, Ferguson A. Human intestinal mucosal mast cells: expanded population in untreated coeliac disease. Gut. 1983 Mar;24(3):222-7. doi: 10.1136/gut.24.3.222.
- Derived from this study: PubMed 34797778Cartee AK, Choung RS, King KS, Wang S, Dzuris JL, Anderson RP, Van Dyke CT, Hinson CA, Marietta E, Katzka DA, Nehra V, Grover M, Murray JA. Plasma IL-2 and Symptoms Response after Acute Gluten Exposure in Subjects With Celiac Disease or Nonceliac Gluten Sensitivity. Am J Gastroenterol. 2022 Feb 1;117(2):319-326. doi: 10.14309/ajg.0000000000001565.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Joseph A. Murray, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten in people with Celiac Disease and Wheat Hypersensitivity, run by Mayo Clinic at 1 site in United States.
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 15 inclusion and 25 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 7 Jun 2019. 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 United States. 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?
Activation of the Mucosal Innate Immune System after Oral Gluten Challenge (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288831, which also lists 11 linked publications.
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 7 Jun 2019.