Irritable Bowel Syndrome With DiarrheaPhase 2NCT06297421
Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults
A Phase 2 study testing Fecal Microbiota Transplantation in people with Irritable Bowel Syndrome With Diarrhea and Fecal Microbiota Transplantation, run by Shenzhen Hospital of Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea, Fecal Microbiota Transplantation, Mental Health Issue
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.
- Age between 18 and 29 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.
- IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (a) Abdominal pain is related to defecation; （b） Abdominal pain accompanied by changes in the frequency of defecation; （c） Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was >25% for Bristol fecal trait type 6 or 7, and <25% for Bristol fecal trait type 1 or 2；and a Hamilton Depression Scale score: 20-34 and/or a Hamilton Anxiety Scale score: 14-28 were evaluated as depressed or anxious patients;
- Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was >5mm or the number of intestinal polyps was >3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.
- The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.
- During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.
Who cannot join
- Patients with constipated, mixed and amorphous IBS.
- Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).
- Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.
- Known to have lactose intolerance and celiac disease.
- There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.
- Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section but no intestinal complications, hernia repair.
Show all 19Show fewer
- Patients with severe mental disorders other than depression and anxiety.
- Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant.
- People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage.
- Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and/or ALT≥2 times upper limit of normal (ULN) and/or total bilirubin ≥1.5 times upper limit of normal (ULN).
- A history of drug or alcohol abuse.
- Even with the help of liquids, patients are unable to take oral solid dosage forms.
- Allergic to experimental drugs, rescue drugs and their ingredients.
- During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc.
- A woman who is pregnant or breastfeeding.
- At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan.
- Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent.
- The patient had previously participated in a clinical study of FMT and received FMT therapy.
- According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518000
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults: A Randomized, Double-blind, Placebo Controlled Study
The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults.
- Conditions
- Irritable Bowel Syndrome With Diarrhea, Fecal Microbiota Transplantation, Mental Health Issue
- Being tested
- Fecal Microbiota Transplantation, Placebo
- Keywords
- Irritable Bowel Syndrome with Diarrhea, Fecal Microbiota Transplantation, Randomized Controlled Study, Mental Health Comorbidity, Young Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationProcedure or surgery
Oral Fecal Microbiota Transplantation Capsule
PlaceboProcedure or surgery
Oral Placebo Capsule
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Oral Fecal Microbiota Transplantation Capsule Take 40 capsules daily, 20 capsules in the morning and 20 capsules in the evening for 3 consecutive days. This is a cycle. Take it for three consecutive cycles. Receives: Procedure: Fecal Microbiota Transplantation |
| Placebo | Placebo comparator | Oral Placebo Capsule Take 40 capsules daily, 20 capsules in the morning and 20 capsules in the evening for 3 consecutive days. This is a cycle. Take it for three consecutive cycles. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Were Composite Weekly Responders
A patient is categorized as a composite weekly responder if the patient achieved the prespecified response displayed in the following for at least 50% of the weeks during the interval from weeks 1-12.
Abdominal pain response: a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline.
Stool consistency response: a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline.
Measured: 1-12 weeks
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0
The number of participants with adverse events both severe and non-severe, assessed for severity based on the 5-grade criteria set by the NCI CTCAE version 5.0.
Measured: 1-52weeks
Secondary outcomes (11)
Percentage of Patients Who Were Composite Weekly Responders
A patient is categorized as a composite weekly responder if the patient achieved the prespecified response displayed in the following for at least 50% of the weeks during the interval from weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Abdominal pain response: a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline.
Stool consistency response: a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline.
Measured: 1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Pain Weekly Responder
A patient is categorized as an abdominal pain weekly responder if the patient achieved prespecified response, i.e. a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline on at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Measured: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Stool Consistency Weekly Responder
A patient is categorized as an stool consistency weekly responder if the patient achieved prespecified response, i.e. a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline on at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Measured: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Bloating Weekly Responder
A patient is categorized as an abdominal bloating weekly responder if the patient achieved prespecified response, i.e. a decrease in the weekly average of worst abdominal bloating (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline on at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Measured: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale
Relief of IBS symptoms was assessed once weekly by patients answering the IBS Symptoms Relief Scale in the electronic diary. Responders were defined as patients with a weekly response of "Yes" to relief of their IBS symptoms for at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Measured: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours
Symptoms of abdominal pain were measured by the 11-point NRS-scale, where 0 corresponded to no abdominal pain and 10 corresponded to worst imaginable abdominal pain. A negative change from Baseline indicates the abdominal pain decreased.
Measured: 1-12 weeks
Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7
Patients recorded the number of days per week with at least one stool with consistency of Type 6 or 7 during weeks 1-12. Stool consistency was measured by the Bristol Stool Form Scale.
Measured: 1-12 weeks
Change from Baseline in the Number of Stools of Type 6 or 7 per Week
Patients recorded the number of stools of Type 6 or 7 every day during weeks 1-12. Stool consistency was measured by the Bristol Stool Form Scale.
Measured: 1-12 weeks
Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score
Symptoms of abdominal bloating were measured by the 11-point NRS-scale, where 0 corresponded to no abdominal bloating and 10 corresponded to worst imaginable abdominal bloating. A negative change from Baseline indicates the abdominal bloating decreased.
Measured: 1-12 weeks
Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores
The IBS Symptom Severity Score is produced from 5 symptom responses on the questionnaire, the total score with a possible range of scores from 0 to 500. A negative change from Baseline indicates that IBS symptom severity improved.
Measured: week4、week8、week9、week12、week20、week28、week36、week44、week52
Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.
Measured: week4、week8、week9、week12、week20、week28、week36、week44、week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Ye, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297421
- Sponsor's protocol ID
- SZYY20240229IBS-D
- Status last verified
- Jul 2024
- First submitted
- 29 Feb 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation for the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults: A Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06297421
- Acronym / sponsor ID
- SZYY20240229IBS-D
- Conditions
- Irritable Bowel Syndrome With Diarrhea, Fecal Microbiota Transplantation, Mental Health Issue
- Keywords
- Irritable Bowel Syndrome with Diarrhea, Fecal Microbiota Transplantation, Randomized Controlled Study, Mental Health Comorbidity, Young Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Mar 2024 (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 study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Procedure: Fecal Microbiota TransplantationOral Fecal Microbiota Transplantation Capsule Take 40 capsules daily, 20 capsules in the morning and 20 capsules in the evening for 3 consecutive days. This is a cycle. Take it for three consecutive cycles. |
| Placebo | Placebo comparator | Procedure: PlaceboOral Placebo Capsule Take 40 capsules daily, 20 capsules in the morning and 20 capsules in the evening for 3 consecutive days. This is a cycle. Take it for three consecutive cycles. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.
- Age between 18 and 29 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.
- IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (a) Abdominal pain is related to defecation; （b） Abdominal pain accompanied by changes in the frequency of defecation; （c） Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was >25% for Bristol fecal trait type 6 or 7, and <25% for Bristol fecal trait type 1 or 2；and a Hamilton Depression Scale score: 20-34 and/or a Hamilton Anxiety Scale score: 14-28 were evaluated as depressed or anxious patients;
- Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was >5mm or the number of intestinal polyps was >3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.
- The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.
Key exclusion criteria (19 listed)
- Patients with constipated, mixed and amorphous IBS.
- Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).
- Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.
- Known to have lactose intolerance and celiac disease.
- There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.
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 |
|---|---|---|
| Fecal Microbiota TransplantationOral Fecal Microbiota Transplantation Capsule | Procedure or surgery | Fecal Microbiota Transplantation |
| PlaceboOral Placebo Capsule | Procedure or surgery | Placebo |
Primary outcome
Percentage of Patients Who Were Composite Weekly Responders
Time frame: 1-12 weeks
A patient is categorized as a composite weekly responder if the patient achieved the prespecified response displayed in the following for at least 50% of the weeks during the interval from weeks 1-12. Abdominal pain response: a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline. Stool consistency response: a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline.
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0
Time frame: 1-52weeks
The number of participants with adverse events both severe and non-severe, assessed for severity based on the 5-grade criteria set by the NCI CTCAE version 5.0.
11 secondary outcomes
Percentage of Patients Who Were Composite Weekly Responders
Time frame: 1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Pain Weekly Responder
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Stool Consistency Weekly Responder
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Bloating Weekly Responder
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours
Time frame: 1-12 weeks
Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7
Time frame: 1-12 weeks
Change from Baseline in the Number of Stools of Type 6 or 7 per Week
Time frame: 1-12 weeks
Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score
Time frame: 1-12 weeks
Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores
Time frame: week4、week8、week9、week12、week20、week28、week36、week44、week52
Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores
Time frame: week4、week8、week9、week12、week20、week28、week36、week44、week52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation in people with Irritable Bowel Syndrome With Diarrhea and Fecal Microbiota Transplantation, run by Shenzhen Hospital of Southern Medical University at 1 site in China.
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 19 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 16 Jul 2024. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ye Chen, M.D (13189606428, 1473355495@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Were Composite Weekly Responders (time frame: 1-12 weeks). The study lists 2 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 16 Jul 2024.