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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

Tracking Information
First Submitted Date  ICMJE July 27, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE August 10, 2018
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03613545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Official Title  ICMJE Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Single (Participant)
Masking Description:
Masking only Participant
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Fecal Microbiota Transplantation
Intervention  ICMJE
  • Procedure: fecal microbiota transplantation
    200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon
  • Procedure: Infusion of sham
    Infusion of sham
  • Drug: probiotics, antibiotics or antidepressants
    Drugs such as probiotics, antibiotics, antidepressants
    Other Names:
    • rifaximin
    • Clostridium butyricum TO-A
Study Arms  ICMJE
  • Experimental: fecal microbiota transplantation
    fecal microbiota transplantation
    Intervention: Procedure: fecal microbiota transplantation
  • Sham Comparator: placebo fecal microbiota transplantation
    Infusion of sham
    Intervention: Procedure: Infusion of sham
  • Sham Comparator: Traditional treatments
    Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants
    Intervention: Drug: probiotics, antibiotics or antidepressants
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2030
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com
Contact: Huiting Chen, MM 86-13926055294 gracy1977@tom.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03613545
Other Study ID Numbers  ICMJE K-2017-078-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guangzhou First People's Hospital
Study Sponsor  ICMJE Guangzhou First People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hongli Huang, MM Guangzhou First People's Hospital
PRS Account Guangzhou First People's Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP