Crohn Disease (CD)NCT06917443
Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)
A study testing Abdominally targeted exercises and General exercises in people with Crohn Disease (CD) and IBD (Inflammatory Bowel Disease), run by Shmuel Kivity, MD at 1 site in Israel.
Trial summary
The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients. The main questions it aims to answer are: Does abdominally targeted exercises can improve the quality of life of CD patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn Disease (CD), IBD (Inflammatory Bowel Disease)
- What is being tested?
- Abdominally targeted exercises and General exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2025to Aug 2029
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with no treatment or on constant medicinal therapy, expected to remain constant: mesalamine for at least 6 weeks, steroids at least 2 weeks (≤20mg prednisone or budesonide ≤6mg), immunomodulatory at least 12 weeks or biologics/ small molecules for at least 12 weeks therapy. Patients who initiate the study on steroids will remain on a constant dose throughout the study.
- If patients stopped therapy prior to the study then they should be at least 2 weeks from stopping steroids or 5ASA, or 4 weeks from stopping small molecules, 8 weeks from stopping biologics, or 12 weeks from stopping thiopurines.
- CD patients will be included if their symptoms score >4 and ≤15 on the HBI score
- Fecal calprotectin>150ug/gr or evidence of an active disease per IUS defined as increased blood flow (modified Limberg score>0) or thickness of bowel wall>3mm
Who cannot join
- Inability to commit for performing at least 10-15 minutes of exercise, 6 times a week.
- Lack of availability or capability to use a computer/ internet.
- Any proven current infection such as, fever, active abscess, Clostridioides difficile infection, positive stool culture, or parasite in patients with chronic diarrhea.
- Inability to sign informed consent and/ or complete the study protocol.
- Incompetent individuals who are unable to provide informed consent.
- Planed pregnancy or pregnancy- up to 3 months post labor.
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- Subjects with chronic conditions such as active arthritis, cancer (within the previous 5 years, not including BCC, SCC), organ transplant subjects, advanced kidney or liver disease, or systemic inflammatory conditions other than IBD.
- Patients who underwent surgery in the previous 3 months, had more than 1 surgery of intestinal resection, patients with ileostomy, pouch or patients with short bowel (small intestine<1.5 meter).
- Patients with a significant abdominal wall hernia, unless received a written confirmation from a treating surgeon.
- Active peri-anal disease (fistula, abscess, fissure), stricturing or penetrating disease
- Active extra-intestinal manifestations (not excluded are- oral aphthae and peripheral arthralgia without arthritis)
- Patients on total parenteral nutrition (TPN) or on exclusive enteral nutrition (EEN).
- Probiotics or antibiotics in the 15 days prior to enrollment or during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center
Tel Aviv, Israel
Rony Izhar, PhD, +972504991116, ronyi@tlvmc.gov.il
Nitsan Maharshak, Professor
About this study
The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients.
The main questions it aims to answer are:
Read more
Does abdominally targeted exercises can improve the quality of life of CD patients.
Does abdominally targeted exercises positively influence clinical and biological responses in CD patients.
Researchers will compare performing sets of special physical exercises designed for CD patients, compared to a control set of exercises ("generic" physical activity) to see if exercises designed for CD can result in an improved quality of life, in CD patients suffering from mild to moderate disease activity.
Participants will:
- Perform physical exercises designed for CD or control set of exercises every day for 8 weeks.
- Visit the clinic once every 4 weeks for doctor visit, blood and stool test and filling out questionnaires.
Read the detailed description
Inflammatory bowel diseases (IBD) are chronic relapsing diseases that carry considerable impact on patients' quality of life (QoL) including objective measures such as increased bowel movements and more subjective measures such as fatigue, stress and depression. While the pathogenesis of IBD is thought to result from a deregulated immune response towards microbial antigens in a genetically predisposed person, various associations of environmental factors and disease activity have been described. These include, but are not limited to diet, stress, physical activity, and microbial composition and function.
Mild to moderate physical activity, which by itself can be beneficial for patients who suffer from chronic disabling diseases such as IBD, is thought to have positive effects on health, general well-being and stress. The positive effects of physical activity can be mediated directly and/ or secondarily through its impact on other modifying factors such as sleep quality, bowel circadian rhythm, and perceived stress. In this regard, by reducing stress through physical activity, one can not only improve patients' QoL and reported outcomes (PROMs) such as sleep quality and stress reduction, which are an important measure by themselves; but also to improve subjective measures of the disease severity. Additionally, physical activity can impact the enteric microbiome, which can be beneficial in IBD patients.
It is currently not clear whether routine physical activity, performed by IBD patients, improves their symptoms, disease activity and quality of lives and if yes, which activity is mostly recommended.
In this study, the investigator intends to further examine whether these disease-specifically designed exercise sets can improve patients' perceived QoL and positively influence clinical and biological responses.
The hypothesize anticipates performing sets of special physical exercises designed for IBD patients, compared to a control set of exercises, can result in an improved QoL, in CD patients suffering from mild to moderate disease activity.
The effect of each set of exercises on patients' QoL, clinical and biological responses through symptoms severity, inflammatory biomarkers, intestinal ultrasound, change in microbiome and gut permeability, will be evaluated.
For this aim, CD patients suffering from mild to moderate disease will be randomized to undergo either a set of specific physical exercises for CD or a control set of unrelated exercises. Patients will be randomized to either group by a computer randomization program according to disease activity (5<HBI≤7 or 7<HBI≤15) and biomarker status (Fecal calprotectin below or above 350ugr/gr). Patients will receive an email with the link to an internet site where they will be able to watch the exercise program.
Videos sets of exercises will be available online and patients will be able to watch and follow these videos at their home. Each video will include explicit instructions and examples for each of the exercises.
Compliance will be documented by the study coordinator (by mail or phone call) every week during the first 2 weeks and then every 2 weeks until the end of the study. This will be verified through the software itself, which documents whenever a patient activates the video.
All patients should remain on consistent dietary regimen throughout the study period.
Patients will attend research visits at weeks 0, 4, and 8. During visits patients will answer questionnaires for QoL (IBDQ), and PROMs (PROMIS-29); and will be monitored for disease activity. At these time points, patients will give biologic samples:
- Serum- 20 ml of blood will be drawn for serum analysis of CRP concentration and for LPS binding protein (LBP). Serum will also be frozen for future metabolome analysis.
- Stool - analyzed for inflammatory marker calprotectin, as well as microbial composition and function.
Data collection will include basic medical and demographic information, including gender, age, weight, height, smoking and exercise habits. Medical data will include age at diagnosis, disease duration, CD Montreal classification, HBI (Harvey-Bradshaw Index), lab results (CRP, LBP and calprotectin), comorbidities, medications history and previous intestinal surgery.
- Being tested
- Abdominally targeted exercises, General exercises
- Keywords
- physical exercise, Crohn's disease, randomized trial
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominally targeted exercisesOther
The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation.
General exercisesOther
Generally recommended exercises, without particular attention to the abdomen
| Study group | Role | What they receive |
|---|---|---|
| Abdominally targeted exercises | Experimental | The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible. Receives: Other: Abdominally targeted exercises |
| Generally recommended exercises | Placebo comparator | The control arm will practice generally recommended exercises, without particular attention to the abdomen. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible. Receives: Other: General exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Clinical response rate will be assessed by using a clinical activity index, Harvey-Bradshaw index (HBI), and defined by a decrease of ≥3 points. A greater decrease is regarded as a better response.
Measured: From enrollment to the end of treatment at 8 weeks
Clinical remission rate
Clinical remission rate will be assessed by using a clinical activity index, HBI defined by achieving HBI<5. Lower scores indicate lower disease activity and severity.
Measured: From enrollment to the end of treatment at 8 weeks
Biomarker remission rate
biomarker remission as defined by calprotectin <150 μg/g. Lower levels indicate better outcome
Measured: From enrollment to the end of treatment at 8 weeks
Biomarker remission rate
Biomarker remission as defined by CRP levels <5 mg/L. Lower levels indicate better outcome
Measured: From enrollment to the end of treatment at 8 weeks
Change from Baseline in mean values of PROMIS-29 scores
To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Measured: From enrollment to the end of treatment at 8 weeks
Change from Baseline in mean values of IBDQ
To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Biomarker response rate
Biomarker response will be assessed by a 50% decrease in fecal calprotectin. Greater decrease indicates better response.
Measured: From enrollment to the end of treatment at 8 weeks
IUS remission rate
IUS remission will be determined by modified Limberg score evaluating bowel wall vascularity. Score range between grade 0 to 4. Remission is defined by modified Limberg score= 0.
Measured: End of treatment at 8 weeks
Clinical remission rate
Clinical remission rate will be assessed by using a clinical activity index, HBI defined by achieving HBI<5. Lower scores indicate lower disease activity and severity.
Measured: From enrollment to 4 weeks
Clinical response rate
Clinical response rate will be assessed by using a clinical activity index, Harvey-Bradshaw index (HBI), and defined by a decrease of ≥3 points. A greater decrease is regarded as a better response.
Measured: From enrollment to 4 weeks
Change from Baseline in mean values of PROMIS-29 scores
To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Measured: From enrollment to 4 weeks
Change from Baseline in mean values of IBDQ
To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: From enrollment to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either intervention or control arm in 2:1 ratio, respectively.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shmuel Kivity, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Shmuel Kivity, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Nitsan Maharshak, Professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917443
- Sponsor's protocol ID
- 0438-24-TLV
- Other IDs
- MOH_2024-11-20_013744
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)
- ClinicalTrials.gov ID
- NCT06917443
- Acronym / sponsor ID
- 0438-24-TLV
- Keywords
- physical exercise, Crohn's disease, randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shmuel Kivity, MDOther government
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 8 Apr 2025 (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.
The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients.
The main questions it aims to answer are:
Does abdominally targeted exercises can improve the quality of life of CD patients.
Does abdominally targeted exercises positively influence clinical and biological responses in CD patients.
Researchers will compare performing sets of special physical exercises designed for CD patients, compared to a control set of exercises ("generic" physical activity) to see if exercises designed for CD can result in an improved quality of life, in CD patients suffering from mild to moderate disease activity.
Participants will:
- Perform physical exercises designed for CD or control set of exercises every day for 8 weeks.
- Visit the clinic once every 4 weeks for doctor visit, blood and stool test and filling out questionnaires.
Detailed description
Inflammatory bowel diseases (IBD) are chronic relapsing diseases that carry considerable impact on patients' quality of life (QoL) including objective measures such as increased bowel movements and more subjective measures such as fatigue, stress and depression. While the pathogenesis of IBD is thought to result from a deregulated immune response towards microbial antigens in a genetically predisposed person, various associations of environmental factors and disease activity have been described. These include, but are not limited to diet, stress, physical activity, and microbial composition and function.
Mild to moderate physical activity, which by itself can be beneficial for patients who suffer from chronic disabling diseases such as IBD, is thought to have positive effects on health, general well-being and stress. The positive effects of physical activity can be mediated directly and/ or secondarily through its impact on other modifying factors such as sleep quality, bowel circadian rhythm, and perceived stress. In this regard, by reducing stress through physical activity, one can not only improve patients' QoL and reported outcomes (PROMs) such as sleep quality and stress reduction, which are an important measure by themselves; but also to improve subjective measures of the disease severity. Additionally, physical activity can impact the enteric microbiome, which can be beneficial in IBD patients.
It is currently not clear whether routine physical activity, performed by IBD patients, improves their symptoms, disease activity and quality of lives and if yes, which activity is mostly recommended.
In this study, the investigator intends to further examine whether these disease-specifically designed exercise sets can improve patients' perceived QoL and positively influence clinical and biological responses.
The hypothesize anticipates performing sets of special physical exercises designed for IBD patients, compared to a control set of exercises, can result in an improved QoL, in CD patients suffering from mild to moderate disease activity.
The effect of each set of exercises on patients' QoL, clinical and biological responses through symptoms severity, inflammatory biomarkers, intestinal ultrasound, change in microbiome and gut permeability, will be evaluated.
For this aim, CD patients suffering from mild to moderate disease will be randomized to undergo either a set of specific physical exercises for CD or a control set of unrelated exercises. Patients will be randomized to either group by a computer randomization program according to disease activity (5<HBI≤7 or 7<HBI≤15) and biomarker status (Fecal calprotectin below or above 350ugr/gr). Patients will receive an email with the link to an internet site where they will be able to watch the exercise program.
Videos sets of exercises will be available online and patients will be able to watch and follow these videos at their home. Each video will include explicit instructions and examples for each of the exercises.
Compliance will be documented by the study coordinator (by mail or phone call) every week during the first 2 weeks and then every 2 weeks until the end of the study. This will be verified through the software itself, which documents whenever a patient activates the video.
All patients should remain on consistent dietary regimen throughout the study period.
Patients will attend research visits at weeks 0, 4, and 8. During visits patients will answer questionnaires for QoL (IBDQ), and PROMs (PROMIS-29); and will be monitored for disease activity. At these time points, patients will give biologic samples:
- Serum- 20 ml of blood will be drawn for serum analysis of CRP concentration and for LPS binding protein (LBP). Serum will also be frozen for future metabolome analysis.
- Stool - analyzed for inflammatory marker calprotectin, as well as microbial composition and function.
Data collection will include basic medical and demographic information, including gender, age, weight, height, smoking and exercise habits. Medical data will include age at diagnosis, disease duration, CD Montreal classification, HBI (Harvey-Bradshaw Index), lab results (CRP, LBP and calprotectin), comorbidities, medications history and previous intestinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to either intervention or control arm in 2:1 ratio, respectively.
| Arm | Type | Receives |
|---|---|---|
| Abdominally targeted exercises | Experimental | Other: Abdominally targeted exercisesThe interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible. |
| Generally recommended exercises | Placebo comparator | Other: General exercisesThe control arm will practice generally recommended exercises, without particular attention to the abdomen. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with no treatment or on constant medicinal therapy, expected to remain constant: mesalamine for at least 6 weeks, steroids at least 2 weeks (≤20mg prednisone or budesonide ≤6mg), immunomodulatory at least 12 weeks or biologics/ small molecules for at least 12 weeks therapy. Patients who initiate the study on steroids will remain on a constant dose throughout the study.
- If patients stopped therapy prior to the study then they should be at least 2 weeks from stopping steroids or 5ASA, or 4 weeks from stopping small molecules, 8 weeks from stopping biologics, or 12 weeks from stopping thiopurines.
- CD patients will be included if their symptoms score >4 and ≤15 on the HBI score
- Fecal calprotectin>150ug/gr or evidence of an active disease per IUS defined as increased blood flow (modified Limberg score>0) or thickness of bowel wall>3mm
Key exclusion criteria (13 listed)
- Inability to commit for performing at least 10-15 minutes of exercise, 6 times a week.
- Lack of availability or capability to use a computer/ internet.
- Any proven current infection such as, fever, active abscess, Clostridioides difficile infection, positive stool culture, or parasite in patients with chronic diarrhea.
- Inability to sign informed consent and/ or complete the study protocol.
- Incompetent individuals who are unable to provide informed consent.
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 |
|---|---|---|
| Abdominally targeted exercisesThe interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation. | Other | Abdominally targeted exercises |
| General exercisesGenerally recommended exercises, without particular attention to the abdomen | Other | Generally recommended exercises |
Primary outcome
Clinical response rate
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical response rate will be assessed by using a clinical activity index, Harvey-Bradshaw index (HBI), and defined by a decrease of ≥3 points. A greater decrease is regarded as a better response.
Clinical remission rate
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical remission rate will be assessed by using a clinical activity index, HBI defined by achieving HBI<5. Lower scores indicate lower disease activity and severity.
Biomarker remission rate
Time frame: From enrollment to the end of treatment at 8 weeks
biomarker remission as defined by calprotectin <150 μg/g. Lower levels indicate better outcome
Biomarker remission rate
Time frame: From enrollment to the end of treatment at 8 weeks
Biomarker remission as defined by CRP levels <5 mg/L. Lower levels indicate better outcome
Change from Baseline in mean values of PROMIS-29 scores
Time frame: From enrollment to the end of treatment at 8 weeks
To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Change from Baseline in mean values of IBDQ
Time frame: From enrollment to the end of treatment at 8 weeks
To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ)
6 secondary outcomes
Biomarker response rate
Time frame: From enrollment to the end of treatment at 8 weeks
IUS remission rate
Time frame: End of treatment at 8 weeks
Clinical remission rate
Time frame: From enrollment to 4 weeks
Clinical response rate
Time frame: From enrollment to 4 weeks
Change from Baseline in mean values of PROMIS-29 scores
Time frame: From enrollment to 4 weeks
Change from Baseline in mean values of IBDQ
Time frame: From enrollment to 4 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 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nitsan Maharshak, Professor principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominally targeted exercises and General exercises in people with Crohn Disease (CD) and IBD (Inflammatory Bowel Disease), run by Shmuel Kivity, MD at 1 site in Israel.
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 13 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: opening soon, as of the sponsor's last update on 8 Apr 2025. 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 Israel. 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 Nitsan Maharshak, Professor (+972527360384, nitsanm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 6 primary outcomes in all. 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 8 Apr 2025.