Ulcerative ColitisNCT05606939
The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Assiut University.
Trial summary
In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- intestinal ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 12 Mar 2024
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study
Who may be able to join
- Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study
- moderate to severe UC patients
- immunosuppressant or corticosteroid refractory disease
- those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy
Who cannot join
- Patients with UC who are under age of 18 years' old
- Patients with UC who aren't eligible to biological therapy
- patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,……)
- Patient refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis
Read the detailed description
Ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease.
performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 MHz) and high-frequency linear probe (5-17 MHz) .
Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains Crohn's disease, ulcerative colitis, and other conditions. IBD is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes
Intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in IBD. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (UC). Visualization of the vascularization of the bowel using color Doppler sonography and, direct visualization of motility.
A study done : IUS is preferred for monitoring the disease course and for assessing short-term treatment response. Found that monitoring bowel wall thickening (BWT) alone has the potential to predict the therapeutic response.The primary therapeutic goal in UC is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)Or the use of biologic therapies ( infliximab.)
- Conditions
- Ulcerative Colitis
- Being tested
- intestinal ultrasound
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal ultrasoundDevice
All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness as well as stratification and Visualization of the vascularization of the bowel using color Doppler sonography also visualization of motility.
Findings of intestinal ultrasound will be compared regrading colonoscopic findings
What is being measured
The primary outcome is the main question the study is designed to answer.
the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis
All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness in mm as well as stratification normal or dirupted and Visualization of the vascularization (normal decrease or increased) of the bowel using color Doppler sonography also visualization of motility (normal , increased or decreaed) Findings of intestinal ultrasound will be compared regrading colonoscopic findings to evaluate the response to biological therapy through IUS
Measured: Baseline , 2 weeks , 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion12 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Ayoub Melk, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606939
- Sponsor's protocol ID
- IUS in ulcerative colitis
- Status last verified
- Oct 2022
- First submitted
- 3 Aug 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zakeri N, Pollok RC. Diagnostic imaging and radiation exposure in inflammatory bowel disease. World J Gastroenterol. 2016 Feb 21;22(7):2165-78. doi: 10.3748/wjg.v22.i7.2165.
PubMed 26900282Atkinson NSS, Bryant RV, Dong Y, Maaser C, Kucharzik T, Maconi G, Asthana AK, Blaivas M, Goudie A, Gilja OH, Nuernberg D, Schreiber-Dietrich D, Dietrich CF. How to perform gastrointestinal ultrasound: Anatomy and normal findings. World J Gastroenterol. 2017 Oct 14;23(38):6931-6941. doi: 10.3748/wjg.v23.i38.6931.
PubMed 29097866Jauregui-Amezaga A, Rimola J. Role of Intestinal Ultrasound in the Management of Patients with Inflammatory Bowel Disease. Life (Basel). 2021 Jun 23;11(7):603. doi: 10.3390/life11070603.
PubMed 34201630Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216.
PubMed 33098642
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05606939
- Acronym / sponsor ID
- IUS in ulcerative colitis
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 12 Mar 2024 (estimated)
- First posted
- 7 Nov 2022 (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.
In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis
Detailed description
Ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease.
performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 MHz) and high-frequency linear probe (5-17 MHz) .
Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains Crohn's disease, ulcerative colitis, and other conditions. IBD is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes
Intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in IBD. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (UC). Visualization of the vascularization of the bowel using color Doppler sonography and, direct visualization of motility.
A study done : IUS is preferred for monitoring the disease course and for assessing short-term treatment response. Found that monitoring bowel wall thickening (BWT) alone has the potential to predict the therapeutic response.The primary therapeutic goal in UC is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)Or the use of biologic therapies ( infliximab.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study
Key inclusion criteria (4 listed)
- Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study
Key exclusion criteria (4 listed)
- Patients with UC who are under age of 18 years' old
- Patients with UC who aren't eligible to biological therapy
- patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,……)
- Patient refuse to participate in the study.
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 |
|---|---|---|
| intestinal ultrasoundAll patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness as well as stratification and Visualization of the vascularization of the bowel using color Doppler sonography also visualization of motility. Findings of intestinal ultrasound will be compared regrading colonoscopic findings | Device | – |
Primary outcome
the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis
Time frame: Baseline , 2 weeks , 6 weeks
All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness in mm as well as stratification normal or dirupted and Visualization of the vascularization (normal decrease or increased) of the bowel using color Doppler sonography also visualization of motility (normal , increased or decreaed) Findings of intestinal ultrasound will be compared regrading colonoscopic findings to evaluate the response to biological therapy through IUS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 26900282Zakeri N, Pollok RC. Diagnostic imaging and radiation exposure in inflammatory bowel disease. World J Gastroenterol. 2016 Feb 21;22(7):2165-78. doi: 10.3748/wjg.v22.i7.2165.
- Background: PubMed 29097866Atkinson NSS, Bryant RV, Dong Y, Maaser C, Kucharzik T, Maconi G, Asthana AK, Blaivas M, Goudie A, Gilja OH, Nuernberg D, Schreiber-Dietrich D, Dietrich CF. How to perform gastrointestinal ultrasound: Anatomy and normal findings. World J Gastroenterol. 2017 Oct 14;23(38):6931-6941. doi: 10.3748/wjg.v23.i38.6931.
- Background: PubMed 34201630Jauregui-Amezaga A, Rimola J. Role of Intestinal Ultrasound in the Management of Patients with Inflammatory Bowel Disease. Life (Basel). 2021 Jun 23;11(7):603. doi: 10.3390/life11070603.
- Background: PubMed 33098642Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Assiut University.
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 4 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Abanoub Melk (01228261560, abanoub.ayoub@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis (time frame: Baseline , 2 weeks , 6 weeks). 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 NCT05606939, which also lists 4 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 7 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.