AzTrials
AzTrials

Fecal Microbiota TransplantationRIT;TETNCT05253222

Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET

A study testing retrograde image by colonic TET in people with Fecal Microbiota Transplantation and Bowel Obstruction, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE（Multi-slices spiral computed tomography enterography） and MRE（ Magnetic resonance enterography）require patients to take a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
retrograde image by colonic TET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Mar 2022to 1 Jun 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation；
  • Abdominal X-ray or plain CT showed signs of intestinal obstruction;
  • Participants suspected with intestinal stricture according to the recent lower GI endoscopy；
  • Voluntarily sign written informed consent.

Who cannot join

  • Signs of peritonitis, perforation or massive hemorrhage of digestive tract;
  • Accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower GI endoscopy;
  • Allergic to laxatives or iodine contrast agents;
  • Pregnant women;
  • Confirmed or suspected claustrophobia;
  • Inability to understand or provide informed consent

Trial locations and contacts

1 site in 1 country.

Faming Zhang, MD,PhD contact

+8615005160383

fzhang@njmu.edu.cn

China1 site

  • Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

    Faming Zhang, MD, PhD, +86-025-58509883, fzhang@njmu.edu.cn

Other trials in China

About this study

Official title: Methodology and Clinical Value of Retrograde Imaging Technique in Intestinal Obstructive Diseases Mediated by Colonic Transendoscopic Enteral Tubing

The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE（Multi-slices spiral computed tomography enterography） and MRE（ Magnetic resonance enterography）require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. Our study team had confirmed the mid-gut TET could serve as the delivery way of contrast solution for MRE bowel preparation with better accuracy of lesion detection and lower reduction of pain in CD（Crohn's Disease） patients. In this study, contrast solution will be delivered by colonic TET placed by lower GI-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.

Being tested
retrograde image by colonic TET
Keywords
Washed Microbiota Transplantation, Fecal Microbiota Transplantation, Transendoscopic enteral tubing
Medical subject headings
Intestinal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • retrograde image by colonic TETDiagnostic test

    Delivery of contrast fluid by colonic TET Each participant will receive one delivery of 200 ml contrast fluid by colonic TET to the distal portion of the lesion.

    One group will be taken CT investigation, another group will be taken X-ray fluoroscopy.

    Imaging parameters will be collected and evaluated.

Study groups in NCT05253222
Study groupRoleWhat they receive
retrograde imaging by colonic TETExperimentalContrast fluid will be injected through colonic TET in participants with bowel obstruction. Image parameters detected by CT and X-ray fluoroscopy will be evaluated.
Receives: Diagnostic Test: retrograde image by colonic TET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The diagnostic self-confidence score

    Image parameters of the lesion( i e. Location，Nature, Severity, Appearance, Fistula) will be recorded by the reader.

    The diagnostic self-confidence for each image parameter will be determined using a continuous five-grade scoring system from 1 to 5(1 = worst, 2=worsen, 3=normal, 4= better,5 = best).

    For example:

    The doctor's diagnostic self-confidence for Location is worsen ,then the diagnostic self-confidence score will be recorded as 2。

    Measured: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.

  2. Evaluation of comprehensive diagnostic efficiency

    comprehensive diagnostic efficiency=(Location+Nature+Appearance+Fistula+Proximal lesion filled by contrast fluid）. Each positive parameter will be recorded as mark 1, negative mark 0. Each participant will get up to 5 score.

    For example:

    for some one participant ,if the doctor could determine the location and nature of the lesion, however,appearance, fistula and proximal lesion filled by contrast fluid could not be determined, then ,the score of comprehensive diagnostic efficiency equals 2.

    Measured: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.

Secondary outcomes (2)

  1. Adverse reaction

    Adverse reaction( abdominal pain, abdominal distention, nausea, vomiting) will be recorded and graded by score 1 to 5 according to the severity of each symptom.

    Measured: during the process, and no more than 24hours after CT/X-ray fluoroscopy detection

  2. Tolerance

    Tolerance will be evaluated by questionnaire investigation。1--Severely intolerable；2--Moderately intolerable；3--Slightly intolerable；4--Tolerable。

    Measured: during the process, and no more than 24hours after CT/X-ray fluoroscopy detection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Feb 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253222
Sponsor's protocol ID
TET2022N001
Acronym
RIT;TET
Status last verified
Feb 2022
First submitted
7 Feb 2022
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rami Reddy SR, Cappell MS. A Systematic Review of the Clinical Presentation, Diagnosis, and Treatment of Small Bowel Obstruction. Curr Gastroenterol Rep. 2017 Jun;19(6):28. doi: 10.1007/s11894-017-0566-9.

    PubMed 28439845

  • Catena F, De Simone B, Coccolini F, Di Saverio S, Sartelli M, Ansaloni L. Bowel obstruction: a narrative review for all physicians. World J Emerg Surg. 2019 Apr 29;14:20. doi: 10.1186/s13017-019-0240-7. eCollection 2019.

    PubMed 31168315

  • Sheedy SP, Kolbe AB, Fletcher JG, Fidler JL. Computed Tomography Enterography. Radiol Clin North Am. 2018 Sep;56(5):649-670. doi: 10.1016/j.rcl.2018.04.002. Epub 2018 Jul 11.

    PubMed 30119766

  • Masselli G, Gualdi G. CT and MR enterography in evaluating small bowel diseases: when to use which modality? Abdom Imaging. 2013 Apr;38(2):249-59. doi: 10.1007/s00261-012-9961-8.

    PubMed 23011551

  • 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

  • Dai M, Zhang T, Li Q, Cui B, Xiang L, Ding X, Rong R, Bai J, Zhu J, Zhang F. The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):1. doi: 10.1186/s13063-018-3101-x.

    PubMed 30606236

Questions about this trial

What is this clinical trial studying?

A study testing retrograde image by colonic TET in people with Fecal Microbiota Transplantation and Bowel Obstruction, 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 4 inclusion and 6 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 23 Feb 2022. 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 (+8615005160383, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic self-confidence score (time frame: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.). 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 NCT05253222, which also lists 6 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 23 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in