Inflammatory Bowel DiseasesNCT05174754
Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme
A study testing Physician-prescribed Exercise Programme and Best Medical Therapy in people with Inflammatory Bowel Diseases, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Physician-prescribed Exercise Programme and Best Medical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 30 Aug 2022to 22 May 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or above.
- Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
- Be able to provide written informed consent.
- Stable dose of steroids.
- Physically able to complete an exercise programme.
- Healthy controls.
Who cannot join
- Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
- An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
- A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
- Pregnancy.
- Healthy controls with underlying inflammatory conditions.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont Hospital
Dublin
Neasa Mc Gettigan, +35318092810, neasamcgettigan21@rcsi.com
About this study
Official title: The Impact Of A Physician-led Exercise Programme On Quality Of Life, Muscle Mass And Clinical Response In Inflammatory Bowel Disease Patients During Induction With Medical Therapy
The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.
Read the detailed description
After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Physician-prescribed Exercise Programme, Best Medical Therapy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-prescribed Exercise ProgrammeBehavioural
A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles
Best Medical TherapyDrug
Best medical therapy with biologic agent or small-molecule therapy
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease Exercise Group | Experimental | The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes. Receives: Behavioral: Physician-prescribed Exercise Programme; Drug: Best Medical Therapy |
| Inflammatory Bowel Disease Control Group | Other | The IBD control group will be randomized to best medical therapy alone. Receives: Drug: Best Medical Therapy |
| Healthy Control Group | No intervention | A group of healthy controls without inflammatory bowel disease will be included in the study for comparison of inflammatory markers including cytokine analysis and body composition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recruitment rates in both IBD arms.
A calculation of the percentage of people approached who participate in the intervention (recruitment).
Measured: 26 weeks
The retention rate in both IBD arms.
A calculation of the percentage of people approached who complete the intervention.
Measured: 26 weeks
The adherence rate in both IBD arms.
A calculation of the percentage of people approached who adhered to the intervention.
Measured: 26 weeks
Secondary outcomes (12)
Change in muscle mass measured by ultrasound
Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm)
Measured: 26 weeks
Change in muscle mass measured by bioelectrical impedance analysis
Bioelectrical impedance analysis (muscle mass in Kg)
Measured: 26 weeks
Change in visceral fat measured by bioelectrical impedance analysis
Bioelectrical impedance analysis (visceral fat in Kg)
Measured: 26 weeks
Clinical remission in response to exercise intervention
Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis
Measured: 12 and 26 weeks
Change in fatigue score between the IBD groups in response to exercise
Measured using the Fatigue Severity Scale which comprises nine statements, describing the severity and impact of fatigue, with a scale of possible responses ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Measured: 12 and 26 weeks
Change in Quality of Life in response to exercise
Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)- a ten item questionnaire, with 1 to 7 points for each item and higher scores indicating higher quality of life.
Measured: 12 and 26 weeks
Change in endoscopic disease activity between IBD groups
A change in endoscopic appearance of Crohn's using Simple endoscopic score for Crohn's disease (SES CD) (inactive when SES-CD was 0-2; mild when 3-6; moderate 7-15; and severe >16) or Mayo score for ulcerative colitis (Score 0-3, Mayo 3 indicating severe disease, 2 moderate disease, 1 mild disease and 0 inactive).
Measured: 26 weeks
Inflammatory response between IBD groups measured using C-Reactive protein
Change in C-Reactive Protein (mg/L)
Measured: 12 and 26 weeks
Inflammatory response between IBD groups measured using faecal calprotectin
Change in faecal calprotectin (ug/g)
Measured: 12 and 26 weeks
Inflammatory response between IBD groups measured using pro-inflammatory cytokines
Change in circulating pro-inflammatory cytokines (pg/mL)
Measured: 12 and 26 weeks
Change in handgrip strength
Use of Jamar dynamometer to measure handgrip strength in kPa
Measured: 12 and 26 weeks
A change in physical fitness between the IBD patient arms
15% difference in 6-minute walk test (6MWT) distance between the two groups
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start30 Aug 2022
- Primary completion22 Mar 2023 (estimated)
- Study completion22 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Boland, PhD, Principal investigator, Royal College of Surgeons, Ireland and Beaumont Hospital, Dublin, Ireland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174754
- Sponsor's protocol ID
- 21-048
- Status last verified
- Feb 2022
- First submitted
- 8 Nov 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elia J, Kane S. Adult Inflammatory Bowel Disease, Physical Rehabilitation, and Structured Exercise. Inflamm Bowel Dis. 2018 Nov 29;24(12):2543-2549. doi: 10.1093/ibd/izy199.
PubMed 29850914Chan D, Robbins H, Rogers S, Clark S, Poullis A. Inflammatory bowel disease and exercise: results of a Crohn's and Colitis UK survey. Frontline Gastroenterol. 2014 Jan;5(1):44-48. doi: 10.1136/flgastro-2013-100339. Epub 2013 Jul 31.
PubMed 28839750Cronin O, Barton W, Moran C, Sheehan D, Whiston R, Nugent H, McCarthy Y, Molloy CB, O'Sullivan O, Cotter PD, Molloy MG, Shanahan F. Moderate-intensity aerobic and resistance exercise is safe and favorably influences body composition in patients with quiescent Inflammatory Bowel Disease: a randomized controlled cross-over trial. BMC Gastroenterol. 2019 Feb 12;19(1):29. doi: 10.1186/s12876-019-0952-x.
PubMed 30755154Eckert KG, Abbasi-Neureither I, Koppel M, Huber G. Structured physical activity interventions as a complementary therapy for patients with inflammatory bowel disease - a scoping review and practical implications. BMC Gastroenterol. 2019 Jul 2;19(1):115. doi: 10.1186/s12876-019-1034-9.
PubMed 31266461Gatt K, Schembri J, Katsanos KH, Christodoulou D, Karmiris K, Kopylov U, Pontas C, Koutroubakis IE, Foteinogiannopoulou K, Fabian A, Molnar T, Zammit D, Fragaki M, Balomenos D, Zingboim N, Ben Horin S, Mantzaris GJ, Ellul P. Inflammatory Bowel Disease [IBD] and Physical Activity: A Study on the Impact of Diagnosis on the Level of Exercise Amongst Patients With IBD. J Crohns Colitis. 2019 May 27;13(6):686-692. doi: 10.1093/ecco-jcc/jjy214.
PubMed 30561568Jones K, Baker K, Speight RA, Thompson NP, Tew GA. Randomised clinical trial: combined impact and resistance training in adults with stable Crohn's disease. Aliment Pharmacol Ther. 2020 Sep;52(6):964-975. doi: 10.1111/apt.16002. Epub 2020 Jul 30.
PubMed 33119156Jones PD, Kappelman MD, Martin CF, Chen W, Sandler RS, Long MD. Exercise decreases risk of future active disease in patients with inflammatory bowel disease in remission. Inflamm Bowel Dis. 2015 May;21(5):1063-71. doi: 10.1097/MIB.0000000000000333.
PubMed 25723616Klare P, Nigg J, Nold J, Haller B, Krug AB, Mair S, Thoeringer CK, Christle JW, Schmid RM, Halle M, Huber W. The impact of a ten-week physical exercise program on health-related quality of life in patients with inflammatory bowel disease: a prospective randomized controlled trial. Digestion. 2015;91(3):239-47. doi: 10.1159/000371795. Epub 2015 Mar 24.
PubMed 25823689Lamers CR, de Roos NM, Bongers CCWG, Ten Haaf DSM, Hartman YAW, Witteman BJM, Hopman MTE. Repeated prolonged moderate-intensity walking exercise does not appear to have harmful effects on inflammatory markers in patients with inflammatory bowel disease. Scand J Gastroenterol. 2021 Jan;56(1):30-37. doi: 10.1080/00365521.2020.1845791. Epub 2020 Nov 19.
PubMed 33211989Loudon CP, Corroll V, Butcher J, Rawsthorne P, Bernstein CN. The effects of physical exercise on patients with Crohn's disease. Am J Gastroenterol. 1999 Mar;94(3):697-703. doi: 10.1111/j.1572-0241.1999.00939.x.
PubMed 10086654Ng V, Millard W, Lebrun C, Howard J. Low-intensity exercise improves quality of life in patients with Crohn's disease. Clin J Sport Med. 2007 Sep;17(5):384-8. doi: 10.1097/JSM.0b013e31802b4fda.
PubMed 17873551Afzal R, Dowling JK, McCoy CE. Impact of Exercise on Immunometabolism in Multiple Sclerosis. J Clin Med. 2020 Sep 21;9(9):3038. doi: 10.3390/jcm9093038.
PubMed 32967206
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of A Physician-led Exercise Programme On Quality Of Life, Muscle Mass And Clinical Response In Inflammatory Bowel Disease Patients During Induction With Medical Therapy
- ClinicalTrials.gov ID
- NCT05174754
- Acronym / sponsor ID
- 21-048
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 22 Mar 2023 (estimated)
- Study completion
- 22 May 2023 (estimated)
- First posted
- 3 Jan 2022 (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 investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.
Detailed description
After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease Exercise Group | Experimental | Behavioral: Physician-prescribed Exercise Programme, Drug: Best Medical TherapyThe exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes. |
| Inflammatory Bowel Disease Control Group | Other | Drug: Best Medical TherapyThe IBD control group will be randomized to best medical therapy alone. |
| Healthy Control Group | No intervention | –A group of healthy controls without inflammatory bowel disease will be included in the study for comparison of inflammatory markers including cytokine analysis and body composition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or above.
- Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
- Be able to provide written informed consent.
- Stable dose of steroids.
- Physically able to complete an exercise programme.
Key exclusion criteria (5 listed)
- Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
- An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
- A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
- Pregnancy.
- Healthy controls with underlying inflammatory conditions.
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 |
|---|---|---|
| Physician-prescribed Exercise ProgrammeA 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles | Behavioural | Inflammatory Bowel Disease Exercise Group |
| Best Medical TherapyBest medical therapy with biologic agent or small-molecule therapy | Drug | Inflammatory Bowel Disease Control Group, Inflammatory Bowel Disease Exercise Group |
Primary outcome
The recruitment rates in both IBD arms.
Time frame: 26 weeks
A calculation of the percentage of people approached who participate in the intervention (recruitment).
The retention rate in both IBD arms.
Time frame: 26 weeks
A calculation of the percentage of people approached who complete the intervention.
The adherence rate in both IBD arms.
Time frame: 26 weeks
A calculation of the percentage of people approached who adhered to the intervention.
12 secondary outcomes
Change in muscle mass measured by ultrasound
Time frame: 26 weeks
Change in muscle mass measured by bioelectrical impedance analysis
Time frame: 26 weeks
Change in visceral fat measured by bioelectrical impedance analysis
Time frame: 26 weeks
Clinical remission in response to exercise intervention
Time frame: 12 and 26 weeks
Change in fatigue score between the IBD groups in response to exercise
Time frame: 12 and 26 weeks
Change in Quality of Life in response to exercise
Time frame: 12 and 26 weeks
Change in endoscopic disease activity between IBD groups
Time frame: 26 weeks
Inflammatory response between IBD groups measured using C-Reactive protein
Time frame: 12 and 26 weeks
Inflammatory response between IBD groups measured using faecal calprotectin
Time frame: 12 and 26 weeks
Inflammatory response between IBD groups measured using pro-inflammatory cytokines
Time frame: 12 and 26 weeks
Change in handgrip strength
Time frame: 12 and 26 weeks
A change in physical fitness between the IBD patient arms
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 29850914Elia J, Kane S. Adult Inflammatory Bowel Disease, Physical Rehabilitation, and Structured Exercise. Inflamm Bowel Dis. 2018 Nov 29;24(12):2543-2549. doi: 10.1093/ibd/izy199.
- Background: PubMed 28839750Chan D, Robbins H, Rogers S, Clark S, Poullis A. Inflammatory bowel disease and exercise: results of a Crohn's and Colitis UK survey. Frontline Gastroenterol. 2014 Jan;5(1):44-48. doi: 10.1136/flgastro-2013-100339. Epub 2013 Jul 31.
- Background: PubMed 30755154Cronin O, Barton W, Moran C, Sheehan D, Whiston R, Nugent H, McCarthy Y, Molloy CB, O'Sullivan O, Cotter PD, Molloy MG, Shanahan F. Moderate-intensity aerobic and resistance exercise is safe and favorably influences body composition in patients with quiescent Inflammatory Bowel Disease: a randomized controlled cross-over trial. BMC Gastroenterol. 2019 Feb 12;19(1):29. doi: 10.1186/s12876-019-0952-x.
- Background: PubMed 31266461Eckert KG, Abbasi-Neureither I, Koppel M, Huber G. Structured physical activity interventions as a complementary therapy for patients with inflammatory bowel disease - a scoping review and practical implications. BMC Gastroenterol. 2019 Jul 2;19(1):115. doi: 10.1186/s12876-019-1034-9.
- Background: PubMed 30561568Gatt K, Schembri J, Katsanos KH, Christodoulou D, Karmiris K, Kopylov U, Pontas C, Koutroubakis IE, Foteinogiannopoulou K, Fabian A, Molnar T, Zammit D, Fragaki M, Balomenos D, Zingboim N, Ben Horin S, Mantzaris GJ, Ellul P. Inflammatory Bowel Disease [IBD] and Physical Activity: A Study on the Impact of Diagnosis on the Level of Exercise Amongst Patients With IBD. J Crohns Colitis. 2019 May 27;13(6):686-692. doi: 10.1093/ecco-jcc/jjy214.
- Background: PubMed 33119156Jones K, Baker K, Speight RA, Thompson NP, Tew GA. Randomised clinical trial: combined impact and resistance training in adults with stable Crohn's disease. Aliment Pharmacol Ther. 2020 Sep;52(6):964-975. doi: 10.1111/apt.16002. Epub 2020 Jul 30.
- Background: PubMed 25723616Jones PD, Kappelman MD, Martin CF, Chen W, Sandler RS, Long MD. Exercise decreases risk of future active disease in patients with inflammatory bowel disease in remission. Inflamm Bowel Dis. 2015 May;21(5):1063-71. doi: 10.1097/MIB.0000000000000333.
- Background: PubMed 25823689Klare P, Nigg J, Nold J, Haller B, Krug AB, Mair S, Thoeringer CK, Christle JW, Schmid RM, Halle M, Huber W. The impact of a ten-week physical exercise program on health-related quality of life in patients with inflammatory bowel disease: a prospective randomized controlled trial. Digestion. 2015;91(3):239-47. doi: 10.1159/000371795. Epub 2015 Mar 24.
- Background: PubMed 33211989Lamers CR, de Roos NM, Bongers CCWG, Ten Haaf DSM, Hartman YAW, Witteman BJM, Hopman MTE. Repeated prolonged moderate-intensity walking exercise does not appear to have harmful effects on inflammatory markers in patients with inflammatory bowel disease. Scand J Gastroenterol. 2021 Jan;56(1):30-37. doi: 10.1080/00365521.2020.1845791. Epub 2020 Nov 19.
- Background: PubMed 10086654Loudon CP, Corroll V, Butcher J, Rawsthorne P, Bernstein CN. The effects of physical exercise on patients with Crohn's disease. Am J Gastroenterol. 1999 Mar;94(3):697-703. doi: 10.1111/j.1572-0241.1999.00939.x.
- Background: PubMed 17873551Ng V, Millard W, Lebrun C, Howard J. Low-intensity exercise improves quality of life in patients with Crohn's disease. Clin J Sport Med. 2007 Sep;17(5):384-8. doi: 10.1097/JSM.0b013e31802b4fda.
- Background: PubMed 32967206Afzal R, Dowling JK, McCoy CE. Impact of Exercise on Immunometabolism in Multiple Sclerosis. J Clin Med. 2020 Sep 21;9(9):3038. doi: 10.3390/jcm9093038.
- 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.
Karen Boland, PhD principal investigator
Royal College of Surgeons, Ireland and Beaumont Hospital, Dublin, Ireland.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-prescribed Exercise Programme and Best Medical Therapy in people with Inflammatory Bowel Diseases, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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 Ireland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Boland, PhD (018092810, karenjboland@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recruitment rates in both IBD arms. (time frame: 26 weeks). The study lists 3 primary outcomes in all. 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 NCT05174754, which also lists 12 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 1 Nov 2022.