NCT02335281

Brief Summary

There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

January 7, 2015

Last Update Submit

January 8, 2015

Conditions

Inflammatory Bowel DiseaseUlcerative ColitisCrohn's Disease

Keywords

Standardized Fecal Microbiota TransplantationInflammatory Bowel DiseaseUlcerative ColitisCrohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical remission (defined as HBI score ≦ 4)

    Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence

    up to one year

Secondary Outcomes (1)

  • Hospitalization days

    up to one year

Study Arms (2)

Standardized FMT

EXPERIMENTAL

The group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once.

Procedure: FMT

Mesalazine

ACTIVE COMPARATOR

This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment.

Drug: Mesalazine

Interventions

FMTPROCEDURE

Standardized FMT once

Standardized FMT
MesalazineDRUG

2g Po perday

Also known as: Mesalamine
Mesalazine

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe IBD define as HBI score ≥ 9.
  • Moderate IBD define as 7\<HBI \<9
  • Montreal classification: Age \> 14 years old, Location L1-3, Behavior B1-3.

You may not qualify if:

  • Diarrhea activity scores \< 3
  • Severely active disease with perianal diseases
  • Severely active disease with indication of surgery.
  • Diagnosis as IBD first time or first year.
  • No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Dongfeng Chen, doctor

    Third Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Dongfeng Chen, doctor

CONTACT

86-13883032812chedf1981@126.com

Yanling Wei, doctor

CONTACT

86-15310354666lingzi016@126.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 INVESTIGATOR
PI Title
Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

CN(1)