A Pilot Study of FMT on CD Patients With AIEC

NCT05611866 | Unknown

• 1 other identifier: FMT CD AIEC study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease

Keywords

Fecal Microbiota Transplant; Adherent-invasive Escherichia coli

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  Occurrence of any adverse events

  12 weeks

Secondary Outcomes (5)

• Change in AIEC colonization

  Week 12

• Change in inflammatory biomarker Erythrocyte sedimentation rate (ESR)

  Week 12

• Change in inflammatory biomarker C-reactive protein (CRP)

  Week 12

• Change in fecal microbiota

  Week 12

• Disease Severity

  Week 12

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

Recruited patients will receive Fecal Microbiota Transplantation

Procedure: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation PROCEDURE

FMT at Week 0

Fecal Microbiota Transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 000000, Hong Kong

Location

Related Publications (14)

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MeSH Terms

Conditions

Crohn Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Siew Chien Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All recruited patients will receive FMT.

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 10, 2022
• Study Start: October 12, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)