Health TrialsbyHealthPanel

Fecal Microbiota Transplantation for Ulcerative Colitis

ConditionsUlcerative ColitisFecal Microbiota Transplantation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangzhou First People's Hospital

About this trial

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Active, moderate to severe severity (Mayo score more than 6)

Safety using history of 5-ASA

Able to undergo endoscopy examination

Disqualifiers

Antibiotic using in 7 days

High risk of toxic megacolon

Colon cancer or neoplasia in pathophysiology

Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal microbiota transplantation

    Procedure/Surgery

    200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine

  • Infusion of Saline

    Procedure/Surgery

    Infusion of Saline

  • 5-Aminosalicylic acid(5-ASA) and/or Prednisone

    Drug

    Mesalazine and/or Prednisone

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Fecal microbiota transplantationExperimental treatment 2 interventions
Group B: placebo fecal microbiota transplantationSham comparator 2 interventions
Group C: Traditional treatmentsOther 1 intervention

Trial outcomes

Primary outcomes

1

Clinical remission in patient as assessed using Mayo score

Total Mayo score less than 2 and no signal item more than 1

Time frame
12 weeks
2

Clinical improvement in patient as assessed using Mayo score

Total Mayo score decreased more than 3

Time frame
12 weeks

Secondary outcomes

1

Intestinal microbiota changing

The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou First People's Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now