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

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

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