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Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease(IBD).However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fecal microbiota transplantation | Experimental | fecal microbiota transplantation |
|
| placebo fecal microbiota transplantation | Sham Comparator | Infusion of sham |
|
| Traditional treatments | Sham Comparator | Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota transplantation | Procedure | 200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS) | This questionnaire was used for assessing IBS severity. Scores of five questions were calculated with the Visual Analogue Scale (VAS) scale: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits and interference with quality of life. The scores ranged from 0 to 500, a higher score indicating worse condition :<75 indicated remission; 75-175 indicated mild IBS;176-300 indicated moderate IBS; and > 300 indicated severe IBS . | baseline; one month;three months;six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores | The IBS-QOL questionnaire consisted of 34 items, covering eight aspects (dysphoria, interference with activity, body image, health worry, food avoidance,social reaction, sexual dysfunction, and relationships). Each item was rated on a 5-point Likert scale(1 = not at all, 5 = a great deal). Total scores were transformed to a 0±100 scale ranging from 0 (maximum quality of life) to 100 (poor quality of life). |
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Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Huang, MM | Contact | 86-13631316718 | honglisums@126.com | |
| Huiting Chen, MM | Contact | 86-13926055294 | gracy1977@tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongli Huang, MM | Guangzhou First People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26900286 | Background | Distrutti E, Monaldi L, Ricci P, Fiorucci S. Gut microbiota role in irritable bowel syndrome: New therapeutic strategies. World J Gastroenterol. 2016 Feb 21;22(7):2219-41. doi: 10.3748/wjg.v22.i7.2219. |
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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 |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D019936 | Probiotics |
| D000900 | Anti-Bacterial Agents |
| D000928 | Antidepressive Agents |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019587 | Dietary Supplements |
| D005502 | Food |
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Parallel Assignment
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Masking only Participant
| Infusion of sham | Procedure | Infusion of sham |
|
| probiotics, antibiotics or antidepressants | Drug | Drugs such as probiotics, antibiotics, antidepressants |
|
|
| baseline; one month;three months;six months |
| Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA) | The Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) were used to evaluate the mental and psychological states of patients. HAMD scores were graded as follows: 8-19, mild depression; 20-34, moderate depression; ≥35, severely depression. HAMA scores were graded as follows: 14-20, mild anxiety; 21-28, moderate anxiety;≥29 , severe anxiety. | baseline; one month;three months;six months |
| D004066 | Digestive System Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |