NCT03804931

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
56mo left

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2019Dec 2030

First Submitted

Initial submission to the registry

January 6, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 15, 2019

Status Verified

November 1, 2018

Enrollment Period

10 years

First QC Date

January 6, 2019

Last Update Submit

January 12, 2019

Conditions

Ulcerative ColitisFecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (2)

  • Clinical remission in patient as assessed using Mayo score

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

    12 weeks

  • Clinical improvement in patient as assessed using Mayo score

    Total Mayo score decreased more than 3

    12 weeks

Secondary Outcomes (1)

  • Intestinal microbiota changing

    12 weeks

Study Arms (3)

Fecal microbiota transplantation

EXPERIMENTAL

Fecal microbiota transplantation

Procedure: Fecal microbiota transplantationDrug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone

placebo fecal microbiota transplantation

SHAM COMPARATOR

Infusion of Saline

Procedure: Infusion of SalineDrug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone

Traditional treatments

OTHER

Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone

Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone

Interventions

Fecal microbiota transplantationPROCEDURE

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

Fecal microbiota transplantation
Infusion of SalinePROCEDURE

Infusion of Saline

placebo fecal microbiota transplantation
5-Aminosalicylic acid(5-ASA) and/or PrednisoneDRUG

Mesalazine and/or Prednisone

Also known as: Mesalazine, Prednisone
Fecal microbiota transplantationTraditional treatmentsplacebo fecal microbiota transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active, moderate to severe severity (Mayo score more than 6)
  • Safety using history of 5-ASA
  • Able to undergo endoscopy examination

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

  • Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

    PMID: 26363929BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota TransplantationPrednisoneMesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compoundsmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Yuqiang Nie, MD

    Guangzhou First People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Huang, MM

CONTACT

86-13631316718honglisums@126.com

Huiting Chen, MM

CONTACT

86-13926055294gracy1977@tom.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 15, 2019

Study Start

January 20, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

January 15, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)