IBS (Irritable Bowel Syndrome)NCT07591584
A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
A study testing FODMAP-targeting digestive enzyme blend in people with IBS (Irritable Bowel Syndrome) and Bloating, run by Kiwi Health Inc at 1 site in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1 The study's rationale is based on the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBS (Irritable Bowel Syndrome), Bloating, Abdominal Pain
- What is being tested?
- FODMAP-targeting digestive enzyme blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to 26 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years old or older
- Screening score of >= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale.
- Screening severity score of >= 55 on the PROMIS Scale v1.0 - Gastrointestinal Belly Pain scale.
- Screening score of <10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- Adults with or without IBS are eligible; participants with IBS experiencing symptoms must meet the Rome IV criteria as determined by the Rome IV Diagnostic Questionnaire (R4DQ) IBS Module.
- Able to maintain 80% compliance with daily questionnaires during the 2 week run-in period.
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- In good general health at the time of screening (Investigator discretion).
- Able to read and understand English and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science.
- Able to receive shipment of the product at an address within the United States.
- Able to complete study assessments over the course of up to 19 weeks.
Who cannot join
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Concomitant Therapies:
- Participants receiving any of the following treatments or therapies are excluded:
- Any investigational therapies or treatments (pharmaceuticals, devices, supplements) within 30 days prior to randomization.
- Ongoing psychological therapies specifically targeting gastrointestinal symptoms or functional disorders, including but not limited to GI-directed Cognitive Behavioral Therapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-Brain Interaction (DGBI).
- Treatment with Glucagon-like peptide-1 (GLP-1) agonists (e.g., semaglutide, tirzepatide) within the last 90 days prior to randomization, due to their known effects on gut motility and GI symptoms.
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- Current or recent (within the last 6 months) chemotherapy or immunotherapy for cancer treatment.
- Current or planned use of any other digestive enzymes prescription or over-the-counter (OTC).
- Chronic use (defined as daily use for >30 days within the last 90 days) of any medication known to have substantial gastrointestinal side effects (e.g., diarrhea, constipation, nausea) that, in the opinion of the Principal Investigator, may confound the assessment of study outcomes. This may include high-dose NSAIDs, opioids, prokinetics, bile acid binders, or certain antibiotics.
- Variable use of probiotics, fiber supplements, laxatives, stool softeners, antidiarrheals (if taking) in the last 30 days. Variable use is defined as use of any probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with a dose change greater than 50% in the last 30 days or initiation or discontinuation of a gut-active product in the last 30 days.
- Other Illnesses or Conditions:
- Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding
- History of bariatric or other significant gastrointestinal surgery (e.g., small bowel resection, total colectomy) that has permanently altered GI anatomy or function. Standard appendectomy or cholecystectomy are generally permitted.
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes (e.g., Type I diabetes, Endometriosis, etc.).
- Acute gastroenteritis within the past 4 weeks;
- New diagnosis workup planned during study that may change diagnosis/ behavior/ medications (eg. colonoscopy prep or major bowel cleanse, upcoming GI consult that could affect eligibility).
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- Self-reported known hypersensitivity or previous allergic reaction to corn and/or any previous reaction to digestive enzyme supplements (eg. Beano and Lactaid)
- Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease, Microscopic Colitis, history of small bowel or colonic surgeries, Celiac disease, or Bile Acid Malabsorption (BAM).
- Screening score of ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- On a low FODMAP diet based on FODMAP FFQ results at Screening
- History of following a low FODMAP diet in the past 6 months (self-reported)
- Any history of following LFD (Low FODMAP Diet) with no response (i.e. failed LFD in past)
- Participants who are on or plan to initiate a major restrictive or elimination diet, or a structured weight-loss diet, during the study period.
- No planned changes in diet, lifestyle or medications for IBS during study period.
- Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization.
- Participants planning extended travel that would interfere with compliance or study procedures.
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
People Science
Los Angeles, California, 90045
Megha Doshi, MD, 213 3280919, megha@peoplescience.health
About this study
This study is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1
The study's rationale is based on the fact that fermentable carbohydrates (FODMAPs) are often poorly absorbed and can trigger symptoms like bloating and abdominal pain. While a Low FODMAP Diet (LFD) is clinically validated for symptom relief, it is restrictive. The enzyme blend is intended to offer a more flexible, enzyme-based solution by targeting and breaking down FODMAPs, such as fructan, GOS, and lactose, before they ferment in the colon.
The primary objective is to evaluate the product's impact on bloating symptoms, measured by the mean PROMIS scale Gastrointestinal Gas and Bloating score. Secondary and exploratory objectives include assessing the impact on overall gastrointestinal symptom severity (IBS-SSS), abdominal pain (PROMIS Belly Pain score), food-related quality of life (FR-QoL-29), and anxiety (GAD-7 scores). The study also aims to evaluate these effects across various Irritable Bowel Syndrome (IBS) subgroups (IBS-C, IBS-D, IBS-M). The trial is a consumer-driven, decentralized research study utilizing validated patient-reported outcome measures that can be completed in a home setting.
Read the detailed description
The study product is a FODMAP-targeting digestive enzyme blend designed as a novel, consumer-grade digestive enzyme supplement. Its primary function is to target and break down fermentable short-chain carbohydrates (FODMAPs) in the gut, specifically fructan, Galacto-oligosaccharides (GOS), and lactose, before they can be fermented in the colon.
The product offers an enzyme-based approach to managing symptoms, such as bloating and abdominal pain, which are often triggered by FODMAPs in individuals with Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), endometriosis, and the broader non-IBS population. This is intended as a more flexible alternative to a Low FODMAP Diet (LFD), which is clinically proven for symptom relief but can be restrictive and difficult to maintain long-term.
Key Characteristics and Use:
Administration: The study product/placebo is to be taken with each meal, snack, or substantial beverage and is applied directly to the food.
Safety and Risk Mitigation: As a digestive enzyme supplement, potential minor risks include temporary gastrointestinal side effects like GI upset, increased gas, or mild changes in bowel habits. To mitigate the risk of allergic reaction, participants with a self-reported known hypersensitivity to corn or previous reactions to digestive enzyme supplements (e.g., Beano and Lactaid) are excluded from the study.
Regulatory Context: This product is a consumer-grade supplement being evaluated in a research study and is not intended to diagnose, prevent, cure, or mitigate specific medical diseases, nor is the research intended to support FDA-regulated drug applications.
- Conditions
- IBS (Irritable Bowel Syndrome), Bloating, Abdominal Pain, Gut Health
- Being tested
- FODMAP-targeting digestive enzyme blend, Placebo
- Keywords
- bloating, gas, abdominal pain, IBS
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FODMAP-targeting digestive enzyme blendDietary supplement
Targeted Action: It is a novel enzyme blend designed to break down specific Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAPs)-fructan, Galacto-oligosaccharides (GOS), and lactose-before they ferment in the colon.
Administration: It must be taken with each meal, snack, or substantial beverage and applied directly to the food.
Study Population: It targets adults with self-reported bloating, including those with Irritable Bowel Syndrome (IBS-C, IBS-D, IBS-M) and non-IBS populations.1 Safety/Exclusion: Participants with a known hypersensitivity to corn or prior reactions to other digestive enzyme supplements (e.g., Beano and Lactaid) are specifically excluded to mitigate risk.
Regulatory Status: It is evaluated as a consumer-grade supplement in decentralized research and is explicitly not intended to support FDA-regulated drug applications or provide medical management.
PlaceboOther
An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Half the participants will start on Arm A. They will use product from Arm A for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm B for the next four weeks. Receives: Dietary Supplement: FODMAP-targeting digestive enzyme blend |
| Arm B | Placebo comparator | Half the participants will start on Arm B. They will use product from Arm B for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm A for the next four weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloating Symptoms
The Primary outcome will be to evaluate the impact of FODMAP-targeting digestive enzyme blend use on bloating symptoms. This will be done by using the Mean PROMIS scale Gastrointestinal Gas and Bloating score between study product and placebo groups at the end of each study product use period.
Scale title: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale - Gas and Bloating
Scoring: Typically reported as a standardized T-score (reference population mean = 50, SD = 10).
Minimum/maximum values: T-scores do not have fixed absolute minimum or maximum values, though scores commonly range approximately from 20-80 in practice. The raw summed score range is 11-55 (11 scored items).
Interpretation: Higher scores indicate worse gastrointestinal symptoms (more gas/bloating severity).
Measured: 19 weeks
Secondary outcomes (2)
Gastrointestinal Symptoms
The Secondary outcome measure will be used to evaluate impact of FODMAP-targeting digestive enzyme blend use on gastrointestinal symptom severity. This will be done by using the Mean IBS-SSS score between study product and placebo groups at the end of each study product use period.
Scale title: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Minimum/maximum values: 0-500
Interpretation: Higher scores indicate worse IBS symptom severity. Scores <175 are generally considered mild, 175-300 moderate, and >300 severe IBS symptoms.
Measured: 19 weeks
Abdominal Pain
The secondary outcome measure will be used to evaluate the impact of FODMAP-targeting digestive enzyme blend use on overall abdominal pain. This will be measured using the Mean PROMIS scale Belly Pain score between study product and placebo groups at the end of each study product use period.
Scale title: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale - Belly Pain
Scoring: Typically reported as a standardized T-score (reference population mean = 50, SD = 10).
Minimum/maximum values: T-scores do not have fixed absolute minimum or maximum values, though scores commonly range approximately from 20-80 in practice. The raw summed score range is 6-30 (6 items).
Interpretation: Higher scores indicate worse abdominal pain symptoms.
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start4 May 2026
- Primary completion26 Oct 2026 (estimated)
- Study completion26 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiwi Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashley Mateus, Ph.D., Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591584
- Sponsor's protocol ID
- PS37
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will need to be discussed internally.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
- ClinicalTrials.gov ID
- NCT07591584
- Acronym / sponsor ID
- PS37
- Conditions
- IBS (Irritable Bowel Syndrome), Bloating, Abdominal Pain, Gut Health
- Keywords
- bloating, gas, abdominal pain, IBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kiwi Health IncIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 4 May 2026 (actual)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 15 May 2026 (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 is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1
The study's rationale is based on the fact that fermentable carbohydrates (FODMAPs) are often poorly absorbed and can trigger symptoms like bloating and abdominal pain. While a Low FODMAP Diet (LFD) is clinically validated for symptom relief, it is restrictive. The enzyme blend is intended to offer a more flexible, enzyme-based solution by targeting and breaking down FODMAPs, such as fructan, GOS, and lactose, before they ferment in the colon.
The primary objective is to evaluate the product's impact on bloating symptoms, measured by the mean PROMIS scale Gastrointestinal Gas and Bloating score. Secondary and exploratory objectives include assessing the impact on overall gastrointestinal symptom severity (IBS-SSS), abdominal pain (PROMIS Belly Pain score), food-related quality of life (FR-QoL-29), and anxiety (GAD-7 scores). The study also aims to evaluate these effects across various Irritable Bowel Syndrome (IBS) subgroups (IBS-C, IBS-D, IBS-M). The trial is a consumer-driven, decentralized research study utilizing validated patient-reported outcome measures that can be completed in a home setting.
Detailed description
The study product is a FODMAP-targeting digestive enzyme blend designed as a novel, consumer-grade digestive enzyme supplement. Its primary function is to target and break down fermentable short-chain carbohydrates (FODMAPs) in the gut, specifically fructan, Galacto-oligosaccharides (GOS), and lactose, before they can be fermented in the colon.
The product offers an enzyme-based approach to managing symptoms, such as bloating and abdominal pain, which are often triggered by FODMAPs in individuals with Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), endometriosis, and the broader non-IBS population. This is intended as a more flexible alternative to a Low FODMAP Diet (LFD), which is clinically proven for symptom relief but can be restrictive and difficult to maintain long-term.
Key Characteristics and Use:
Administration: The study product/placebo is to be taken with each meal, snack, or substantial beverage and is applied directly to the food.
Safety and Risk Mitigation: As a digestive enzyme supplement, potential minor risks include temporary gastrointestinal side effects like GI upset, increased gas, or mild changes in bowel habits. To mitigate the risk of allergic reaction, participants with a self-reported known hypersensitivity to corn or previous reactions to digestive enzyme supplements (e.g., Beano and Lactaid) are excluded from the study.
Regulatory Context: This product is a consumer-grade supplement being evaluated in a research study and is not intended to diagnose, prevent, cure, or mitigate specific medical diseases, nor is the research intended to support FDA-regulated drug applications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Dietary Supplement: FODMAP-targeting digestive enzyme blendHalf the participants will start on Arm A. They will use product from Arm A for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm B for the next four weeks. |
| Arm B | Placebo comparator | Other: PlaceboHalf the participants will start on Arm B. They will use product from Arm B for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm A for the next four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals aged 18 years old or older
- Screening score of >= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale.
- Screening severity score of >= 55 on the PROMIS Scale v1.0 - Gastrointestinal Belly Pain scale.
- Screening score of <10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- Adults with or without IBS are eligible; participants with IBS experiencing symptoms must meet the Rome IV criteria as determined by the Rome IV Diagnostic Questionnaire (R4DQ) IBS Module.
Key exclusion criteria (30 listed)
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Concomitant Therapies:
- Any investigational therapies or treatments (pharmaceuticals, devices, supplements) within 30 days prior to randomization.
- Ongoing psychological therapies specifically targeting gastrointestinal symptoms or functional disorders, including but not limited to GI-directed Cognitive Behavioral Therapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-Brain Interaction (DGBI).
- Treatment with Glucagon-like peptide-1 (GLP-1) agonists (e.g., semaglutide, tirzepatide) within the last 90 days prior to randomization, due to their known effects on gut motility and GI symptoms.
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 |
|---|---|---|
| FODMAP-targeting digestive enzyme blendTargeted Action: It is a novel enzyme blend designed to break down specific Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAPs)-fructan, Galacto-oligosaccharides (GOS), and lactose-before they ferment in the colon. Administration: It must be taken with each meal, snack, or substantial beverage and applied directly to the food. Study Population: It targets adults with self-reported bloating, including those with Irritable Bowel Syndrome (IBS-C, IBS-D, IBS-M) and non-IBS populations.1 Safety/Exclusion: Participants with a known hypersensitivity to corn or prior reactions to other digestive enzyme supplements (e.g., Beano and Lactaid) are specifically excluded to mitigate risk. Regulatory Status: It is evaluated as a consumer-grade supplement in decentralized research and is explicitly not intended to support FDA-regulated drug applications or provide medical management. | Dietary supplement | Arm A |
| PlaceboAn inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested. | Other | Arm B |
Primary outcome
Bloating Symptoms
Time frame: 19 weeks
The Primary outcome will be to evaluate the impact of FODMAP-targeting digestive enzyme blend use on bloating symptoms. This will be done by using the Mean PROMIS scale Gastrointestinal Gas and Bloating score between study product and placebo groups at the end of each study product use period. Scale title: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale - Gas and Bloating Scoring: Typically reported as a standardized T-score (reference population mean = 50, SD = 10). Minimum/maximum values: T-scores do not have fixed absolute minimum or maximum values, though scores commonly range approximately from 20-80 in practice. The raw summed score range is 11-55 (11 scored items). Interpretation: Higher scores indicate worse gastrointestinal symptoms (more gas/bloating severity).
2 secondary outcomes
Gastrointestinal Symptoms
Time frame: 19 weeks
Abdominal Pain
Time frame: 19 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. This will need to be discussed internally.
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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.
Ashley Mateus, Ph.D. principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FODMAP-targeting digestive enzyme blend in people with IBS (Irritable Bowel Syndrome) and Bloating, run by Kiwi Health Inc 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 11 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megha Doshi, MD (213 3280919, megha@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloating Symptoms (time frame: 19 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 15 May 2026.