The Study of Efficacy and Mechanism in Fecal Microbiota T... | NCT02435160

Studies
The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

NCT02435160

Sponsor

Jun Liu

Status

Unknown status

Last Update Posted

May 6, 2015Estimated

Enrollment

20Estimated

Phase

Phase 2Phase 3

Conditions

Ulcerative Colitis
Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2015

Last Update Posted Date

May 6, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ulcerative Colitis	Experimental		Biological: Fecal Microbiota Transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fecal Microbiota Transplantation	Biological		Ulcerative Colitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of mayo criteria in UC patients after FMT.		one year
Number of patients with adverse events after FMT.		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mild to moderate UC patients
male
volunteered to our FMT trial

Exclusion Criteria:

severe UC
Hb < 6g/dL

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35962454	Derived	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.

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D001691	Biological Therapy
D013812	Therapeutics