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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Procedure | Oral Fecal Microbiota Transplantation Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1-52weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Chen, M.D | Contact | 13189606428 | 1473355495@qq.com | |
| Jun Huang | Contact | 13189606428 | 1473355495@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Hospital of Southern Medical University | Shenzhen | Guangdong | 518000 | China |
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| Placebo | Procedure | Oral Placebo Capsule |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | week4、week8、week9、week12、week20、week28、week36、week44、week52 |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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