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Status unknownNCT02435160Updated May 6, 2015

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

A Phase 2/3 interventional study of Fecal Microbiota Transplantation in Ulcerative Colitis and Fecal Microbiota Transplantation, sponsored by Jun Liu. Status unknown. Open to male participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by Jun Liu · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
25 Years to 60 Years
Sex
Male
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Study 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.

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Conditions studied

  • Ulcerative Colitis
  • Fecal Microbiota Transplantation
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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Jun Liu is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • mild to moderate UC patients
  • male
  • volunteered to our FMT trial

Exclusion criteria

Exclusion Criteria:

  • severe UC
  • Hb \< 6g/dL
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ulcerative Colitis

    Biological: Fecal Microbiota Transplantation

Interventions

  • BiologicalFecal Microbiota Transplantation
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What researchers measure

Primary outcomes

  1. Change of mayo criteria in UC patients after FMT.

    Time frame: one year

  2. Number of patients with adverse events after FMT.

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 35962454 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02435160
Lead sponsor
Jun Liu
Responsible party
Jun Liu (Shanghai general hospital, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
May 6, 2015
Start date
May 2015
Primary completion
May 2016 (estimated)
Last update
May 6, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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