Fecal Microbiota Transplantation for Irritable Bowel Syndrome

NCT03613545 | Recruiting Phase 2 DMC

• 1 other identifier: K-2017-078-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores

  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)

  baseline; one month;three months;six months

Study Arms (3)

fecal microbiota transplantation

EXPERIMENTAL

fecal microbiota transplantation

Procedure: fecal microbiota transplantation

placebo fecal microbiota transplantation

SHAM COMPARATOR

Infusion of sham

Procedure: Infusion of sham

Traditional treatments

SHAM COMPARATOR

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

Drug: probiotics, antibiotics or antidepressants

Interventions

fecal microbiota transplantation PROCEDURE

200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

fecal microbiota transplantation

Infusion of sham PROCEDURE

Infusion of sham

placebo fecal microbiota transplantation

probiotics, antibiotics or antidepressants DRUG

Drugs such as probiotics, antibiotics, antidepressants

Also known as: rifaximin, Clostridium butyricum TO-A

Traditional treatments

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 26900286 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation; Probiotics; Anti-Bacterial Agents; Antidepressive Agents; Rifaximin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Psychotropic Drugs; Central Nervous System Agents; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Hongli Huang, MM

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Huang, MM

CONTACT

86-13631316718; honglisums@126.com

Huiting Chen, MM

CONTACT

86-13926055294; gracy1977@tom.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking only Participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 3, 2018
• Study Start: August 10, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)