NCT02435160

Brief Summary

The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 23, 2015

Last Update Submit

May 5, 2015

Conditions

Ulcerative ColitisFecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (2)

  • Change of mayo criteria in UC patients after FMT.

    one year

  • Number of patients with adverse events after FMT.

    one year

Study Arms (1)

Ulcerative Colitis

EXPERIMENTAL
Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota TransplantationBIOLOGICAL
Ulcerative Colitis

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mild to moderate UC patients
  • male
  • volunteered to our FMT trial

You may not qualify if:

  • severe UC
  • Hb \< 6g/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Huang C, Huang Z, Ding L, Fu Y, Fan J, Mei Q, Lou L, Wang J, Yin N, Lu Y, Guo S, Zeng Y. Fecal microbiota transplantation versus glucocorticoids for the induction of remission in mild to moderate ulcerative colitis. J Transl Med. 2022 Aug 12;20(1):354. doi: 10.1186/s12967-022-03569-3.

    PMID: 35962454DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shanghai general hospital

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 6, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Last Updated

May 6, 2015

Record last verified: 2015-04