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Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome, Fecal Microbiota Transplantation

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fecal microbiota transplantation
Infusion of sham
probiotics, antibiotics or antidepressants
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

fecal microbiota transplantation

placebo fecal microbiota transplantation

Traditional treatments

Arm Description

fecal microbiota transplantation

Infusion of sham

Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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).
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.

Full Information

First Posted
July 27, 2018
Last Updated
August 1, 2021
Sponsor
Guangzhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03613545
Brief Title
Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Official Title
Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Masking only Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fecal microbiota transplantation
Arm Type
Experimental
Arm Description
fecal microbiota transplantation
Arm Title
placebo fecal microbiota transplantation
Arm Type
Sham Comparator
Arm Description
Infusion of sham
Arm Title
Traditional treatments
Arm Type
Sham Comparator
Arm Description
Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants
Intervention Type
Procedure
Intervention Name(s)
fecal microbiota transplantation
Intervention Description
200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon
Intervention Type
Procedure
Intervention Name(s)
Infusion of sham
Intervention Description
Infusion of sham
Intervention Type
Drug
Intervention Name(s)
probiotics, antibiotics or antidepressants
Other Intervention Name(s)
rifaximin, Clostridium butyricum TO-A
Intervention Description
Drugs such as probiotics, antibiotics, antidepressants
Primary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS)
Description
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 .
Time Frame
baseline; one month;three months;six months
Secondary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores
Description
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).
Time Frame
baseline; one month;three months;six months
Title
Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA)
Description
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.
Time Frame
baseline; one month;three months;six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Huang, MM
Phone
86-13631316718
Email
honglisums@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huiting Chen, MM
Phone
86-13926055294
Email
gracy1977@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongli Huang, MM
Organizational Affiliation
Guangzhou First People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongli Huang, MM
Phone
86-13631316718
Email
honglisums@126.com
First Name & Middle Initial & Last Name & Degree
Huiting chen, MM
Phone
86-13926055294
Email
gracy1977@tom.com
First Name & Middle Initial & Last Name & Degree
Haoming Xu, MM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26900286
Citation
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.
Results Reference
background

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Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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