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Status unknownNCT03917095Updated May 15, 2019

The Safety and Efficacy of TET Enema in the Treatment of UC

An interventional study of The Colonic Transendoscopic enteral Tubing. and Glutamine in Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, 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 2019-05-15.

Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).This clinical trail aims to evaluate the efficacy and safety of Mesalazine and Compound Glutamine enema in the treatment of Ulcerative Colitis through Colonic TET.

Read the detailed description

Enema is a conventional treatment for Ulcerative Colitis(UC). Mesalazine is suitable for the patients with mild to moderate UC.But for the UC with extending lesions, the conventional anema with Mesalazine or other medicine can not very effective.Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).Compared with the conventional enema, which is only used for local administration, the Colonic TET enema can achieve total colonic administration.This study aims to evaluate the efficacy and safety of Colonic TET for UC.Patients in this study will be divided into 5 groups according to certain criteria: the Mesalazine conventional enema group, the Mesalazine TET enema group, the Compound Glutamine conventional enema group, the Compound Glutamine TET enema group, the Mesalazine and Compound Glutamine TET enema group.Each group was given enema for 7 days.The primary outcome measure was the clinical remission efficacy rate in each group. The secondary outcome measure was the safety of TET.

02

Conditions studied

  • Ulcerative Colitis Chronic Mild
  • Ulcerative Colitis Chronic Moderate

Keywords

  • Inflammatory Bowel Disease
  • Transendoscopic Enteral Tubing
  • Mesalazine
  • Compound Glutamine
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 75 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.

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Who can participate

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

Inclusion criteria

  1. Male or female patients aged between 18 and 65
  2. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)
  3. Patients who can fully understand this study and voluntarily sign an informed consent;
  4. Accept re-examination, follow-up examination and specimen retention in time
  5. Suitable for colonoscopy and colonic TET;
  6. A history of using Mesalazine and Compound Glutamine safely

Exclusion criteria

Exclusion Criteria:

  1. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks
  2. Cyclosporine was used within 4 weeks
  3. Antibiotics or probiotics was used within 4 weeks
  4. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology
  5. History of colon surgery
  6. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident
  7. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival
  8. Patients with anxiety, depression, mental or legal disabilities
  9. History of suspected or proven alcohol/drug abuse
  10. Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy
  11. Patients who are allergic to salicylic acid or aspirin
  12. Patients with food allergies
  13. Patients who are preparing to become pregnant during the study period
  14. Patients considered by the researchers as unsuitable for enrollment
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Mesalazine conventional enema

    Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.

    Drug: Mesalazine

  • Experimental
    Mesalazine TET enema

    Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.

    Device: The Colonic Transendoscopic enteral Tubing. · Drug: Mesalazine

  • Active comparator
    Compound Glutamine conventional enema

    Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

    Drug: Glutamine

  • Experimental
    Compound Glutamine TET enema

    Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

    Device: The Colonic Transendoscopic enteral Tubing. · Drug: Glutamine

  • Experimental
    Compound Glutamine and Mesalazine TET enema

    Participants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.

    Device: The Colonic Transendoscopic enteral Tubing. · Drug: Glutamine · Drug: Mesalazine

Interventions

  • DeviceThe Colonic Transendoscopic enteral Tubing.

    The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).

  • DrugGlutamine

    The medications were infused into the colon

    Also known as: Glutamine Product

  • DrugMesalazine

    The medications were infused into the colon

    Also known as: Mesalazine Enema Product

06

What researchers measure

Primary outcomes

  1. Clinical remission rate

    The frequency of defecation and hematochezia score were both zero

    Time frame: 10-days

  2. The effective rate

    Part of the total Mayo score was 3 points lower than the baseline

    Time frame: 10-days

Secondary outcomes

  1. Adverse events

    Number of participants with treatment-related adverse events

    Time frame: 10-days

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

  • Crispino P, Pica R, Unim H, Rivera M, Cassieri C, Zippi M, Paoluzi P. Efficacy of mesalazine or beclomethasone dipropionate enema or their combination in patients with distal active ulcerative colitis. Eur Rev Med Pharmacol Sci. 2015 Aug;19(15):2830-7. PubMed 26241537 ↗
  • Jeong SY, Im YN, Youm JY, Lee HK, Im SY. l-Glutamine Attenuates DSS-Induced Colitis via Induction of MAPK Phosphatase-1. Nutrients. 2018 Mar 1;10(3):288. doi: 10.3390/nu10030288. PubMed 29494494 ↗
  • Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28. PubMed 27556065 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03917095
Lead sponsor
The Second Hospital of Nanjing Medical University
Responsible party
Faming Zhang (Professor, Gastroenterology, The Second Hospital of Nanjing Medical University) — Principal investigator
First posted
Apr 16, 2019
Start date
May 15, 2019 (estimated)
Primary completion
Jun 15, 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
May 15, 2019

Study contacts

Faming Zhang, MD,PhD
Contact
fzhang@njmu.edu.cn
086-25-58509883
Faming Zhang, MD,PhD
principal investigator · The Second Hospital of Nanjing Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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