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NCT Number: NCT03804931

Fecal Microbiota Transplantation for Ulcerative Colitis

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).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Fecal Microbiota Transplantation Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

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

Infusion of Saline

Procedure

Infusion of Saline

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

Drug

Mesalazine and/or Prednisone

Other names: Mesalazine, Prednisone

Primary outcomes

  1. Clinical remission in patient as assessed using Mayo score

    Time frame: 12 weeks

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

  2. Clinical improvement in patient as assessed using Mayo score

    Time frame: 12 weeks

    Total Mayo score decreased more than 3

Secondary outcomes

  1. Intestinal microbiota changing

    Time frame: 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongli Huang, MM

CONTACT

[email protected]

86-13631316718

Huiting Chen, MM

CONTACT

[email protected]

86-13926055294

Sponsors and collaborators

Lead sponsor

Guangzhou First People's Hospital

Other

Registry information

Official study title

Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

Important dates

Study start
2019
Primary completion
2028
Study completion
2030
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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