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Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT03613545
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Guangzhou First People's Hospital

Brief Summary:
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 diseaseIBD).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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Fecal Microbiota Transplantation Procedure: fecal microbiota transplantation Procedure: Infusion of sham Drug: probiotics, antibiotics or antidepressants Phase 2 Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: Masking only Participant
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: fecal microbiota transplantation
fecal microbiota transplantation
Procedure: fecal microbiota transplantation
200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

Sham Comparator: placebo fecal microbiota transplantation
Infusion of sham
Procedure: Infusion of sham
Infusion of sham

Sham Comparator: Traditional treatments
Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants
Drug: probiotics, antibiotics or antidepressants
Drugs such as probiotics, antibiotics, antidepressants
Other Names:
  • rifaximin
  • Clostridium butyricum TO-A




Primary Outcome Measures :
  1. Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS) [ Time Frame: baseline; one month;three months;six months ]
    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 .


Secondary Outcome Measures :
  1. Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores [ Time Frame: baseline; one month;three months;six months ]
    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).

  2. Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA) [ Time Frame: baseline; one month;three months;six months ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must:

  • Be able to give written informed consent.
  • Males and females aged >18 and <75
  • Have IBS as defined by the Rome IV criteria

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria:

  • pregnant or having a follow-up of less than 6 months;
  • unable to give informed consent;
  • suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
  • unable to undergo endoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613545


Contacts
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Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com
Contact: Huiting Chen, MM 86-13926055294 gracy1977@tom.com

Locations
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China, Guangdong
Guangzhou First People's Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Hongli Huang, MM    86-13631316718    honglisums@126.com   
Contact: Huiting chen, MM    86-13926055294    gracy1977@tom.com   
Sub-Investigator: Haoming Xu, MM         
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Hongli Huang, MM Guangzhou First People's Hospital

Publications:
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Responsible Party: Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT03613545     History of Changes
Other Study ID Numbers: K-2017-078-02
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antidepressive Agents
Anti-Infective Agents
Antitubercular Agents
Psychotropic Drugs