Fecal Microbiota Transplantation for Ulcerative Colitis

NCT ID: NCT03804931

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2030-12-31

Brief Summary

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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).

Detailed Description

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The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.

Conditions

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Ulcerative Colitis Fecal Microbiota Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fecal microbiota transplantation

Fecal microbiota transplantation

Group Type EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type PROCEDURE

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

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

Intervention Type DRUG

Mesalazine and/or Prednisone

placebo fecal microbiota transplantation

Infusion of Saline

Group Type SHAM_COMPARATOR

Infusion of Saline

Intervention Type PROCEDURE

Infusion of Saline

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

Intervention Type DRUG

Mesalazine and/or Prednisone

Traditional treatments

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

Group Type OTHER

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

Intervention Type DRUG

Mesalazine and/or Prednisone

Interventions

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Fecal microbiota transplantation

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

Intervention Type PROCEDURE

Infusion of Saline

Infusion of Saline

Intervention Type PROCEDURE

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

Mesalazine and/or Prednisone

Intervention Type DRUG

Other Intervention Names

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Mesalazine Prednisone

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuqiang Nie, MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First People's Hospital

Locations

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Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongli Huang, MM

Role: CONTACT

86-13631316718

Huiting Chen, MM

Role: CONTACT

86-13926055294

Facility Contacts

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Hongli Huang, MM

Role: primary

86-13631316718

Huiting chen, MM

Role: backup

86-13926055294

References

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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.

Reference Type BACKGROUND
PMID: 26363929 (View on PubMed)

Other Identifiers

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K-2017-103-01

Identifier Type: -

Identifier Source: org_study_id

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