Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; Fecal Microbiota Transplantation
• Intervention / Treatment: Procedure: fecal microbiota transplantation; Procedure: Infusion of sham; Drug: probiotics, antibiotics or antidepressants

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hongli Huang, MM; Phone Number: 86-13631316718; Email: honglisums@126.com
• Study Contact Backup: Name: Huiting chen, MM; Phone Number: 86-13926055294; Email: gracy1977@tom.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First People's Hospital
      • Contact: Hongli Huang, MM; Phone Number: 86-13631316718; Email: honglisums@126.com
      • Contact: Huiting chen, MM; Phone Number: 86-13926055294; Email: gracy1977@tom.com
      • Sub-Investigator: Haoming Xu, MM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital
• Investigators: Principal Investigator: Hongli Huang, MM, Guangzhou First People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Psychotropic Drugs; Rifaximin; Anti-Bacterial Agents; Antidepressive Agents
• Other Study ID Numbers: K-2017-078-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No