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Status unknownNCT02998112Updated Dec 20, 2016

Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

A Phase 4 interventional study of fecal microbiota transplantation and Saline in Ulcerative Colitis, sponsored by The Second Hospital of Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-12-20.

Sponsored by The Second Hospital of Nanjing Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

Read the detailed description
  1. Patients with moderate to severe UC will be screened (Mayo>6）.
  2. Participants will be divided into control and study groups by double blind.
  3. Control group and study group will receive a colonic endoscopy evaluation. And a TET tube will be fixed at ileocecum.
  4. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both control and study group. Study and control group will be given with fecal microbiota suspension and equal volume of saline by TET for three times every other day in one week.
  5. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment. All the participants will receive a endoscopy evaluation at 12 weeks. Clinical remission, clinical improvement and safety are the primary endpoint at 12 weeks; Intestinal microbiota changing is recognized as the secondary endpoint.
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Conditions studied

  • Ulcerative Colitis

Keywords

  • fecal microbiota transplantation
  • Ulcerative colitis
03

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 188 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

The Second Hospital of Nanjing Medical University is the lead sponsor of 67 studies on the registry; 34 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Immunosuppressive drugs and glucocorticoids using in 4 weeks
  • 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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
188 participants (estimated)

Study arms

  • Placebo comparator
    control

    5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week

    Drug: Saline

  • Experimental
    Study group

    5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week

    Drug: fecal microbiota transplantation

Interventions

  • Drugfecal microbiota transplantation

    Fecal microbiota which was purified from fresh stool defecated by a healthy donor

  • DrugSaline
06

What researchers measure

Primary outcomes

  1. Clinical remission

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

    Time frame: 12 weeks

  2. Clinical improvement

    Total Mayo score decreased more than 3 or decreased more than 30%

    Time frame: 12 weeks

Secondary outcomes

  1. Intestinal microbiota changing

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

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26363929 ↗
  • Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727. PubMed 25168749 ↗
  • Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7. PubMed 25857665 ↗
  • Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30. PubMed 25836986 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02998112
Lead sponsor
The Second Hospital of Nanjing Medical University
Collaborators
Air Force Military Medical University, China, First Hospital of Guangzhou, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Zhongshan Hospital Xiamen University
Responsible party
Faming Zhang (Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University) — Principal investigator
First posted
Dec 20, 2016
Start date
Dec 2016
Primary completion
Jul 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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