Dyssynergic DefecationNCT07225803
Management of Dyssynergic Defecation
A study testing Biofeedback and Inspiratory muscle training (IMT) in people with Dyssynergic Defecation and Constipation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to better understand constipation and improve biofeedback treatments. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyssynergic Defecation, Constipation
- What is being tested?
- Biofeedback and Inspiratory muscle training (IMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study
- Satisfy Rome III criteria for functional constipation and/or irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing
Who cannot join
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and/or pose safety concerns.
- History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
- Current anal fissure
- Clinically significant structural abnormalities (eg, rectocele > 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms
- Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation
- Pregnant or nursing women, prisoners and institutionalized individuals
Show all 11Show fewer
- BMI >35 kg/m2
- Use of opioid analgesics or GLP-1 receptor agonists. Patients on opioids will be allowed to participate if they have discontinued them for at least 1 week before the date of screening and are willing to stay off them for the duration of the study.
- Current use of anticholinergics (eg. amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline or amitriptyline up to 50 mg/day) will be eligible provided they do not increase the dose during the study period. Patients on higher doses are eligible to participate if it is safe and they are willing to reduce their medication dose at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete.
- Current use of laxatives (Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete (As detailed later, all participants can use Miralax throughout the study).
- Any other factors that increase the risk to participants of participating in the study and/or undermine the integrity of the data.
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
Mayo Clinic
Rochester, Minnesota, 55905
Kelly J. Feuerhak, RN, CCRP, 507-255-6802, feuerhak.kelly@mayo.edu
About this study
The purpose of this research is to better understand constipation and improve biofeedback treatments.
- Conditions
- Dyssynergic Defecation, Constipation
- Being tested
- Biofeedback, Inspiratory muscle training (IMT)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
During anorectal biofeedback therapy, subjects are coached to improve abnormal patterns while observing activity recorded by manometry and/or surface EMG (electromyography) on a computer monitor while seated on a chair or a commode.
Inspiratory muscle training (IMT)Behavioural
Subjects will engage in inspiratory muscle training (IMT) that is tailored to the baseline performance of the individual.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback and inspiratory muscle training (BFT Plus) | Experimental | Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes.
In addition, subjects will engage in inspiratory muscle training (IMT) at home. Receives: Behavioral: Biofeedback; Behavioral: Inspiratory muscle training (IMT) |
| Biofeedback only (BFT Alone) | Active comparator | Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. Receives: Behavioral: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rectoanal gradient during evacuation
Rectoanal gradient during evacuation is the pressure difference between the rectum and the anal canal during simulated evacuation, measured in millimeters of mercury (mmHg).
Measured: Baseline, through study completion, an average of 16 weeks
Change in rectal pressure during evacuation
Rectal pressure during evacuation is the difference in rectal pressure during - before evacuation. Results are measured in millimeters of mercury (mmHg).
Measured: Baseline, through study completion, an average of 16 weeks
Change in balloon expulsion time
Rectal balloon expulsion directly assesses evacuation. Patients will be asked to expel a rectal balloon inflated up to 50 ml of water. The time required to expel the balloon will be measured and reported in seconds.
Measured: Baseline, through study completion, an average of 16 weeks
Change in rectal emptying time
Rectal emptying will be assessed via fecoflowmetry by measuring the time required to defecate (seconds) artificial stool from the rectum
Measured: Baseline, through study completion, an average of 16 weeks
Change in rectal emptying rate
Rectal emptying will be assessed via fecoflowmetry by measuring the amount (gm) of artificial stool from the rectum. The 2 metrics - amount and time - are integrated to measure amount (gm) evacuated per unit time (second) (gm/sec).
Measured: Baseline, through study completion, an average of 16 weeks
Secondary outcomes (23)
Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire
The PAC-SYM questionnaire assesses the severity of patient-reported symptoms related to constipation. The questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Scores range from 0 to 48.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire
The PAC-QOL questionnaire is a patient-reported outcome measure to evaluate quality of life in constipated persons. The questionnaire is divided into four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Scale scores represent average item scores and range from 0 to 4, where higher scores represent poorer quality of life. Scores range from 0 to 112.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion
Physical Activity Rating Scale
Physical Activity Rating is a questionnaire for categorizing physical activity level, which is used in the equation for the non-exercise fitness test. The Physical Activity Rating is a score value between 0 to 7. The non-exercise fitness test of VO2max, a measure of cardiovascular fitness, will be calculated using the following equation:
56.363 + 1.921 (Physical Activity Rating) - 0.381(Age) - 0.754(Body Mass Index) + 10.987(Sex: 0 for women, 1 for men)
Measured: Baseline
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 11-item questionnaire is a standardized tool to measure the satisfaction of an individual who is using an assistive device. It inquiries about the assistive device itself: dimensions, weight, ease of adjustment, safety, durability, ease of use, comfortability, and effectiveness; and service: service delivery, maintenance, professional services, and follow up services. Each question is answered on a Likert scale, where 1 = not satisfied at all, and 5 = very satisfied. Possible scores range from 11 to 55.
Measured: through study completion, an average of 16 weeks
Change in stool frequency
Daily number of bowel movements will be self-reported by participants via a bowel diary.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in stool consistency
Daily stool consistency will be self-reported by participants via a bowel diary by using the Bristol Stool Chart. Participants will compare stool's appearance to the 7 types and selecting the one that most closely matches. Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in anal digitation
The total number of times anal digitation was required to achieve a bowel movement will be self-reported via the bowel diary.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in sense of incomplete evacuation
The total number of times a participant felt a sense of incomplete evacuation after a bowel movement will be self-reported via the bowel diary.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in spontaneous bowel movements
The total number of times a participant achieves a spontaneous bowel movement will be self-reported via the bowel diary.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in pain during bowel movements
Pain during bowel movements will be self-reported by participants via the bowel diary using a 4-point Likert scale (0 = None, 1 = Mild, 3 = Moderate, and 4 = Severe).
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in bowel symptoms before and after biofeedback therapy
Bowel symptoms pre and post biofeedback therapy will be assessed using a self-reported questionnaire. The survey includes Severity of constipation, satisfaction with bowel movements, satisfaction with current treatment of constipation, severity of constipation compared to baseline, adequate relief of constipation, use of laxatives, and severity of abdominal bloating and distention. Impact of constipation on 15 QOL domains.
Measured: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in Hospital Anxiety and Depression (HAD) score
The Hospital Anxiety and Depression (HAD) is a self-reported 14 item questionnaire asking participants to reflect on their mood in the past week. . Each item is rated on a 4-point scale, for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress.
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced vital capacity
Forced vital capacity (FVC) is the the total volume of air exhaled with maximal effort, and is measured using a spirometer (reported in liters).
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory volume
Forced expiratory volume (FEV) is the total volume of air exhaled with maximal effort, and is measured using a spirometer (reported in liters).
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory time
Forced expiratory time (FET) is the time taken to exhale the greatest volume of air from the lungs as possible and is measured using a spirometer (reported in seconds).
Measured: Baseline, through study completion, an average of 16 weeks
Change in peak inspiratory flows
Peak inspiratory flow (PIF) is the maximum volume and rate of air that can be forcefully inhaled out of the lungs, and is measured using a spirometer (reported in liters per second (L/sec)).
Measured: Baseline, through study completion, an average of 16 weeks
Change in peak expiratory flows
Peak expiratory flow (PEF) is the maximum volume and rate of air that can be forcefully exhaled out of the lungs and is measured using a spirometer (reported in in liters per second (L/sec)).
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory volume/forced vital capacity ratio
The total volume of air exhaled with maximal effort / The volume of air exhaled with maximum effort in the first second (reported as percentage).
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory flow at 25-75% of forced vital capacity
The average flow from the point at which 25% of the forced vital capacity has been exhaled to the point at which 75% of the forced vital capacity has been exhaled. A reduced forced expiratory flow 25-75% is a marker of small airway obstruction.
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory flow at 50% of forced vital capacity
The flow rate at the point at which 50% point of the forced vital capacity has been exhaled, and is a marker of small airway obstruction.
Measured: Baseline, through study completion, an average of 16 weeks
Change in forced inspiratory vital capacity
Forced inspiratory vital capacity is the maximum volume of air that can be inhaled after a full expiration (reported in liters).
Measured: Baseline, through study completion, an average of 16 weeks
Change in peak inspiratory pressure
Peak inspiratory pressure is the peak pressure during forceful inspiration against an occluded airway (Mueller maneuver), reported in liters per minute (L/min)
Measured: Baseline, through study completion, an average of 16 weeks
Change in peak expiratory pressure
Peak expiratory pressure is the peak pressure during forceful expiration against an occluded airway (Valsalva maneuver), reported in liters per minute (L/min)
Measured: Baseline, through study completion, an average of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start18 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyssynergic DefecationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adil Bharucha, MBBS, MD, Mayo Clinic
- Investigators
- Adil E. Bharucha, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225803
- Sponsor's protocol ID
- 25-003767
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Dyssynergic Defecation
- ClinicalTrials.gov ID
- NCT07225803
- Acronym / sponsor ID
- 25-003767
- Conditions
- Dyssynergic Defecation, Constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Nov 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 purpose of this research is to better understand constipation and improve biofeedback treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback and inspiratory muscle training (BFT Plus) | Experimental | Behavioral: Biofeedback, Behavioral: Inspiratory muscle training (IMT)Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. In addition, subjects will engage in inspiratory muscle training (IMT) at home. |
| Biofeedback only (BFT Alone) | Active comparator | Behavioral: BiofeedbackSubjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study
- Satisfy Rome III criteria for functional constipation and/or irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing
Key exclusion criteria (11 listed)
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and/or pose safety concerns.
- History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
- Current anal fissure
- Clinically significant structural abnormalities (eg, rectocele > 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms
- Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation
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 |
|---|---|---|
| BiofeedbackDuring anorectal biofeedback therapy, subjects are coached to improve abnormal patterns while observing activity recorded by manometry and/or surface EMG (electromyography) on a computer monitor while seated on a chair or a commode. | Behavioural | Biofeedback and inspiratory muscle training (BFT Plus), Biofeedback only (BFT Alone) |
| Inspiratory muscle training (IMT)Subjects will engage in inspiratory muscle training (IMT) that is tailored to the baseline performance of the individual. | Behavioural | Biofeedback and inspiratory muscle training (BFT Plus) |
Primary outcome
Change in rectoanal gradient during evacuation
Time frame: Baseline, through study completion, an average of 16 weeks
Rectoanal gradient during evacuation is the pressure difference between the rectum and the anal canal during simulated evacuation, measured in millimeters of mercury (mmHg).
Change in rectal pressure during evacuation
Time frame: Baseline, through study completion, an average of 16 weeks
Rectal pressure during evacuation is the difference in rectal pressure during - before evacuation. Results are measured in millimeters of mercury (mmHg).
Change in balloon expulsion time
Time frame: Baseline, through study completion, an average of 16 weeks
Rectal balloon expulsion directly assesses evacuation. Patients will be asked to expel a rectal balloon inflated up to 50 ml of water. The time required to expel the balloon will be measured and reported in seconds.
Change in rectal emptying time
Time frame: Baseline, through study completion, an average of 16 weeks
Rectal emptying will be assessed via fecoflowmetry by measuring the time required to defecate (seconds) artificial stool from the rectum
Change in rectal emptying rate
Time frame: Baseline, through study completion, an average of 16 weeks
Rectal emptying will be assessed via fecoflowmetry by measuring the amount (gm) of artificial stool from the rectum. The 2 metrics - amount and time - are integrated to measure amount (gm) evacuated per unit time (second) (gm/sec).
23 secondary outcomes
Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion
Physical Activity Rating Scale
Time frame: Baseline
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Time frame: through study completion, an average of 16 weeks
Change in stool frequency
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in stool consistency
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in anal digitation
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in sense of incomplete evacuation
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in spontaneous bowel movements
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in pain during bowel movements
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in bowel symptoms before and after biofeedback therapy
Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion
Change in Hospital Anxiety and Depression (HAD) score
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced vital capacity
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory volume
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory time
Time frame: Baseline, through study completion, an average of 16 weeks
Change in peak inspiratory flows
Time frame: Baseline, through study completion, an average of 16 weeks
Change in peak expiratory flows
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory volume/forced vital capacity ratio
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory flow at 25-75% of forced vital capacity
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced expiratory flow at 50% of forced vital capacity
Time frame: Baseline, through study completion, an average of 16 weeks
Change in forced inspiratory vital capacity
Time frame: Baseline, through study completion, an average of 16 weeks
Change in peak inspiratory pressure
Time frame: Baseline, through study completion, an average of 16 weeks
Change in peak expiratory pressure
Time frame: Baseline, through study completion, an average of 16 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 10 Nov 2025.
- 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.
Adil E. Bharucha, MBBS, MD 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 Biofeedback and Inspiratory muscle training (IMT) in people with Dyssynergic Defecation and Constipation, 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 2 inclusion and 11 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 10 Nov 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 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. 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 Kelly J. Feuerhak, RN, CCRP (507-255-6802, feuerhak.kelly@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rectoanal gradient during evacuation (time frame: Baseline, through study completion, an average of 16 weeks). The study lists 5 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 10 Nov 2025.