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The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.
In this prospective study, there is only one group with no placebo/blank control. All qualified IBS-D patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combining therapy | Experimental | taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | 400mg tid* 3d |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with relief of IBS condition | The "responder" should at the same time get relief of at least one item of abdominal discomfort related symptoms(including abdominal pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain) and bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), both items' effectiveness are defined as decreasing at least 30% compared with baseline) and at least one item of defecation related abnomalities(including average daily defecation(effectiveness defined as decreasing at least 30% compared with baseline) and stool consistency(effectiveness defined as feces could reach at least Bristol type 5) ). | 6 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with relief of IBS related anxiety or depression status | The number of patients who have at least 30% decreasing compared with baseline in the score of SAS/SDS/HADS rating scale | 1 month/2 month/3 month/6 month after the treatment |
| Number of patients with relief of IBS single symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| The rate and type of adverse effects | It means any events that occur in the trial process related or unrelated to the drug/fecal microbiota transplantation that do harm to the patients' health, including symptoms/physical signs/abnormal lab values | The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengdi Wu | Contact | (86)13817923359 | wu.shengdi@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xizhong Shen, PhD | Zhongshan Hospital, Shanghai, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Fecal microbiota transplantation | Procedure | Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time |
|
The number of patients who have relief of IBS global score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain), bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicateds very great deal of discomfort), urgency score(0-3 with 0 indicates no urgency and 3 indicates great deal of urgency), average daily defecation, stool consistency(according to Bristol criteria). Except stool consistency, other items' effectiveness are defined as decreasing at least 30% compared with baseline during the whole period of follow-up. Stool consistency's effectiveness is defined as feces could reach at least Bristol type 5 during the whole period of follow-up. |
| 2 week/1 month/2 month/3 month/6 month after the treatment |
| D004066 | Digestive System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |