Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Irritable Bowel Syndrome

The goal of this clinical trial is to assess the efficacy and safety of fecal microbiota transplantation (FMT) for patients with irritable bowel syndrome (IBS). The main objectives of the study are:

To determine if FMT can significantly reduce IBS symptoms and improve patients' quality of life.

To evaluate any potential adverse effects associated with FMT in IBS patients. Researchers will compare outcomes in patients receiving FMT with a standard care protocol to gauge the effectiveness of FMT in alleviating IBS symptoms.

Participants will:

Receive FMT via endoscopic methods as per the study protocol. Attend scheduled clinic visits for assessments and symptom tracking over a 48-week period, with optional long-term follow-up for up to 3 years.

Complete regular questionnaires and microbiota assessments to monitor symptoms and gut health changes over time.

Study Overview

• Status: Active, not recruiting
• Conditions: Irritable Bowel Disease
• Intervention / Treatment: Other: Fecal Microbial Transplantation

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Korean men and women aged 19 to 80 years
2. Diagnosed according to Rome IV criteria, with abdominal pain occurring at least once per week that began more than 6 months prior and has recurred over the past 3 months, accompanied by at least two of the following symptoms: pain related to defecation, changes in stool frequency (increase or decrease), or changes in stool form (looser or harder consistency)
3. Patients with moderate to severe IBS (IBS-SSS score of 175 or higher) with diarrhea-predominant, mixed-type, or abdominal bloating as the main symptom, who have not responded to IBS medication therapy for over 3 months
4. Patients who have had a colonoscopy within the past 5 years, or those who will undergo a colonoscopy after joining the study, and for whom no structural abnormalities in the colon are identified (records from other hospitals within the past 5 years may be used). *Patients who have undergone a biopsy or polypectomy during colonoscopy and can provide examination results are eligible if deemed appropriate by the clinician
5. Females who are surgically infertile or females of childbearing potential with a negative pregnancy test (urine hCG or serum b-hCG); females of childbearing potential or males who agree to use effective contraception (e.g., oral contraceptives, IUD, double-barrier methods, or hormonal implants) during the study period
6. Individuals capable of clearly expressing their intentions without significant neurological or psychiatric issues. Those with neurological or psychiatric conditions may participate if deemed stable with appropriate medication or other treatments
7. Patients who voluntarily provide written informed consent to participate in the study

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Patients who have received investigational drugs within 3 months prior to Visit 1 (if investigational drugs were used within 3 months, consult the study monitor for case-by-case assessment)
3. Patients whom the investigator deems to be at risk or to have conditions that would interfere with participation in the clinical trial
4. Patients with severe congestive heart failure or severe angina
5. Patients diagnosed with lactose intolerance or those who are immunocompromised
6. Patients currently taking medications that may affect the study drug (e.g., intestinal drugs, probiotics), or those who need to continue these medications during the study period. Patients who are currently on these medications can participate after a 2-week washout period
7. Patients whose systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg at Visit 1, with uncontrolled hypertension regardless of treatment status
8. Patients with uncontrolled endocrine disorders (e.g., diabetes), metabolic disorders (e.g., secondary hyperlipidemia), or hypothyroidism. Patients with a history of hypothyroidism may participate if they have been on a stable thyroid hormone replacement therapy for at least 4 weeks before Visit 2 and have a TSH level within the normal range at Visit 2
9. Patients with impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome at Visit 1
10. Patients with a history of cancer within the last 5 years (except for those deemed cured)
11. Patients with significant psychiatric instability or psychiatric disorders not adequately controlled with medication or other treatment
12. Patients who have taken systemic steroid medications within 1 month prior to Visit 1
13. Patients who have undergone abdominal surgery other than appendectomy, cholecystectomy, cesarean section, hernia repair, or hysterectomy. *Patients with other abdominal surgeries may still participate if deemed eligible by the investigator
14. Any other patient whom the investigator deems unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT; Fecal microbiota transplantation: fecal suspension delivered to duodenal 3rd portion via esophagogastroduodenoscopy	Other: Fecal Microbial Transplantation; Fecal suspension is delivered to duodenal 3rd portion via esophagogastroduodenoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of IBS-SSS	At 12 weeks post-FMT, overall satisfaction with the improvement in IBS symptoms will be evaluated, alongside changes in the IBS Symptom Severity Score (IBS-SSS) to comprehensively assess the effects of FMT on individual IBS symptoms.	12weeks after FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IBS-SSS	Change in IBS-SSS Score for IBS Patients (evaluated by the IBS-SSS questionnaire)	4 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Stool Frequency and Form	Changes in Stool Frequency and Form for IBS Patients (evaluated by the BSFS questionnaire)	4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Quality of Life	Changes in Quality of Life for IBS Patients (evaluated by the IBS-QoL questionnaire)	4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Anxiety and Derpession	Changes in Mental Health for IBS Patients (evaluated by the HADS questionnaire)	4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in gut microbiota	Differences in Gut Microbiota Between Responders and Non-Responders	at baseline, 4 weeks, and 12 weeks after FMT

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
• Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15.
• Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
• Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17.
• Wu J, Lv L, Wang C. Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials. Front Cell Infect Microbiol. 2022 Feb 28;12:827395. doi: 10.3389/fcimb.2022.827395. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): July 3, 2024
• Study Completion (Estimated): April 25, 2027

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: IBS; fecal microbiota transplantation; FMT; Irritable bowel disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Intestinal Diseases
• Other Study ID Numbers: B-2210-784-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No