A Pilot Study of FMT on CD Patients With AIEC

May 30, 2023 updated by: Siew Chien NG, Chinese University of Hong Kong

A Pilot Study of Fecal Microbiota Transplant (FMT) and Its Effects in Patients With Crohn's Disease With Moderate-to-High Risk of Colonization of Adherent-Invasive E. Coli (AIEC)

The goal of this pilot study is to test whether Fecal Microbiota Transplant (FMT) would be an effective antibacterial treatment for managing Adherent-invasive Escherichia coli (AIEC) colonization in Crohn's disease (CD) patients.

It aims to assess the safety of FMT in patients with clinically inactive or mild to moderate CD and to determine the presence of AIEC before and after FMT.

Participants will receive FMT via colonoscopy and have a follow-up colonoscopy at the end of the study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Experimental and observational data suggest that intestinal inflammation in Crohn's Disease (CD) arises from abnormal immune response to intestinal microbiota in genetically susceptible individuals. Genes that regulate innate immune response, intestinal barrier function and bacteria killing of intracellular pathogens have been associated with an increased risk for developing CD in Caucasian populations. The search for specific pathogens in CD has identified in the intestinal mucosa of patients several candidates. One with much supporting evidence is the adherent invasive Escherichia coli (AIEC). Since its discovery in 1998, several groups have reported a higher prevalence of AIEC in CD patients compared to healthy subjects and confirmed their pro-inflammatory potential. A growing body of work indicates that different host environments can select such AIEC pathobiont. AIEC colonization in mice leads to strong inflammatory responses in the gut suggesting that AIEC could play a role in CD immunopathogenesis.

Faecal microbiota transplantation (FMT) represents a clinically feasible way to restore the gut microbial ecology and has proven to be a breakthrough for the treatment of recurrent Clostridium difficile infection. Clinical trials are being conducted to evaluate its use for other conditions including inflammatory bowel disease, irritable bowel syndrome, diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. Efficacy of FMT on CD endoscopic lesions and AIEC colonization remains to be demonstrated.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong, 000000
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years of age;
  • Patients with CD history ≥ 3-month duration;
  • Patients with no or mild-to-moderate symptoms defined as Harvey Bradshaw Index (HBI) < 16 ;
  • Patients with positive total E.coli antibodies (AEcAb)

Exclusion Criteria:

  • Pregnancy;
  • New biological treatment or steroids use within 4 weeks;
  • Current Colorectal tumor;
  • Active gastrointestinal bleeding;
  • Having ulcerative colitis;
  • Having colectomy or partial colectomy (less than ileo-transverse colonic anastomosis);
  • Having colonic or small bowel stoma;
  • Active perianal lesions;
  • Receiving antibiotics within 4 weeks;
  • Presenting psychological or linguistic incapability to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbiota Transplantation
Recruited patients will receive Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
FMT at Week 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: 12 weeks
Occurrence of any adverse events
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AIEC colonization
Time Frame: Week 12
Presence of mucosa-associated AIEC before and after receiving FMT
Week 12
Change in inflammatory biomarker Erythrocyte sedimentation rate (ESR)
Time Frame: Week 12
Week 12
Change in inflammatory biomarker C-reactive protein (CRP)
Time Frame: Week 12
Week 12
Change in fecal microbiota
Time Frame: Week 12
Fecal microbiota, including diversity, composition and functional capacity will be measured before and after receiving FMT
Week 12
Disease Severity
Time Frame: Week 12
Harvey Bradshaw Index score will be used to measure disease severity where scores higher than 16 indicate disease activity is severe
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Siew Chien Ng, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2022

Primary Completion (Estimated)

July 31, 2023

Study Completion (Estimated)

July 31, 2023

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT CD AIEC study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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