Ulcerative Colitis Chronic MildNCT03917095
The Safety and Efficacy of TET Enema in the Treatment of UC
A study testing The Colonic Transendoscopic enteral Tubing., Glutamine and Mesalazine in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
- What is being tested?
- The Colonic Transendoscopic enteral Tubing., Glutamine and Mesalazine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 18 and 65
- Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)
- Patients who can fully understand this study and voluntarily sign an informed consent;
- Accept re-examination, follow-up examination and specimen retention in time
- Suitable for colonoscopy and colonic TET;
- A history of using Mesalazine and Compound Glutamine safely
Who cannot join
- Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks
- Cyclosporine was used within 4 weeks
- Antibiotics or probiotics was used within 4 weeks
- Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology
- History of colon surgery
- Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident
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- Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival
- Patients with anxiety, depression, mental or legal disabilities
- History of suspected or proven alcohol/drug abuse
- Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy
- Patients who are allergic to salicylic acid or aspirin
- Patients with food allergies
- Patients who are preparing to become pregnant during the study period
- Patients considered by the researchers as unsuitable for enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail
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.
- Being tested
- The Colonic Transendoscopic enteral Tubing., Glutamine, Mesalazine
- Keywords
- Inflammatory Bowel Disease, Transendoscopic Enteral Tubing, Mesalazine, Compound Glutamine
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Colonic Transendoscopic enteral Tubing.Device
The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).
GlutamineDrug
Also called Glutamine Product
The medications were infused into the colon
MesalazineDrug
Also called Mesalazine Enema Product
The medications were infused into the colon
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine conventional enema | Active comparator | Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week. Receives: Drug: Mesalazine |
| Mesalazine TET enema | Experimental | Participants undergo the TET enema of Mesalazine Enemas (4g) for one week. Receives: Device: The Colonic Transendoscopic enteral Tubing.; Drug: Mesalazine |
| Compound Glutamine conventional enema | Active comparator | Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week. Receives: Drug: Glutamine |
| Compound Glutamine TET enema | Experimental | Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week. Receives: Device: The Colonic Transendoscopic enteral Tubing.; Drug: Glutamine |
| Compound Glutamine and Mesalazine TET enema | Experimental | 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. Receives: Device: The Colonic Transendoscopic enteral Tubing.; Drug: Glutamine; Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
The frequency of defecation and hematochezia score were both zero
Measured: 10-days
The effective rate
Part of the total Mayo score was 3 points lower than the baseline
Measured: 10-days
Secondary outcomes (1)
Adverse events
Number of participants with treatment-related adverse events
Measured: 10-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 May 2019 (estimated)
- Primary completion15 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis Chronic MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD,PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917095
- Sponsor's protocol ID
- TET-CN-190408
- Status last verified
- May 2019
- First submitted
- 12 Apr 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 26241537Jeong 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 29494494Peng 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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail
- ClinicalTrials.gov ID
- NCT03917095
- Acronym / sponsor ID
- TET-CN-190408
- Keywords
- Inflammatory Bowel Disease, Transendoscopic Enteral Tubing, Mesalazine, Compound Glutamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (estimated)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mesalazine conventional enema | Active comparator | Drug: MesalazineParticipants undergo the conventional enema of Mesalazine Enemas (4g) for one week. |
| Mesalazine TET enema | Experimental | Device: The Colonic Transendoscopic enteral Tubing., Drug: MesalazineParticipants undergo the TET enema of Mesalazine Enemas (4g) for one week. |
| Compound Glutamine conventional enema | Active comparator | Drug: GlutamineParticipants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week. |
| Compound Glutamine TET enema | Experimental | Device: The Colonic Transendoscopic enteral Tubing., Drug: GlutamineParticipants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week. |
| Compound Glutamine and Mesalazine TET enema | Experimental | Device: The Colonic Transendoscopic enteral Tubing., Drug: Glutamine, Drug: MesalazineParticipants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged between 18 and 65
- Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)
- Patients who can fully understand this study and voluntarily sign an informed consent;
- Accept re-examination, follow-up examination and specimen retention in time
- Suitable for colonoscopy and colonic TET;
Key exclusion criteria (14 listed)
- Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks
- Cyclosporine was used within 4 weeks
- Antibiotics or probiotics was used within 4 weeks
- Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology
- History of colon surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Colonic Transendoscopic enteral Tubing.The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET). | Device | Compound Glutamine TET enema, Compound Glutamine and Mesalazine TET enema, Mesalazine TET enema |
| GlutamineAlso: Glutamine ProductThe medications were infused into the colon | Drug | Compound Glutamine TET enema, Compound Glutamine and Mesalazine TET enema, Compound Glutamine conventional enema |
| MesalazineAlso: Mesalazine Enema ProductThe medications were infused into the colon | Drug | Compound Glutamine and Mesalazine TET enema, Mesalazine TET enema, Mesalazine conventional enema |
Primary outcome
Clinical remission rate
Time frame: 10-days
The frequency of defecation and hematochezia score were both zero
The effective rate
Time frame: 10-days
Part of the total Mayo score was 3 points lower than the baseline
1 secondary outcome
Adverse events
Time frame: 10-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Background: PubMed 26241537Crispino 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.
- Background: PubMed 29494494Jeong 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.
- Results publication: PubMed 27556065Peng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faming Zhang, MD,PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Colonic Transendoscopic enteral Tubing., Glutamine and Mesalazine in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD,PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: 10-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917095, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.