Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combining therapy taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube |
Drug: Rifaximin
400mg tid* 3d
Other Names:
Procedure: Fecal microbiota transplantation
Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time
|
Outcome Measures
Primary Outcome Measures
- Number of patients with relief of IBS condition [6 months after the treatment]
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) ).
Secondary Outcome Measures
- Number of patients with relief of IBS related anxiety or depression status [1 month/2 month/3 month/6 month after the treatment]
The number of patients who have at least 30% decreasing compared with baseline in the score of SAS/SDS/HADS rating scale
- Number of patients with relief of IBS single symptoms [2 week/1 month/2 month/3 month/6 month after the treatment]
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.
Other Outcome Measures
- The rate and type of adverse effects [The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 65, no gender limitation;
-
Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed;
-
Has current symptoms of IBS-D: â‘ Abdominal pain (at least 2 days in a week with no limitation of severity); â‘¡Stool consistency (rated the consistency of their stools of Bristol types 6/7 at least once a day and at least 2 days in a week);
-
Can do follow-up at required time points and signed written informed consent before the study.
Exclusion Criteria:
-
Allergic to rifaximin;
-
Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month;
-
Had infective diarrhea history or had taken antibiotics within the previous 14 days;
-
Patients with a history of inflammatory bowel disease ;
-
Previous abdominal surgery (other than cholecystectomy or appendectomy);
-
Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs;
-
Unstable diabetes, hypertension, thyroid disease, etc;
-
Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases;
-
Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc;
-
Other conditions that doctor thought not suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital, Fudan University | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Chair: Xizhong Shen, PhD, Zhongshan Hospital, Shanghai, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SXZ-WSD01-2015