UnknownNot Applicable

A Pilot Study of FMT on CD Patients With AIEC

Hong Kong30 participantsStarted 2022-10-12

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Adverse Event

Timeframe: 12 weeks

Trial details

NCT IDNCT05611866

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

View on ClinicalTrials.gov More Crohn Disease trials