AssessIUS Scores inUC Versus ColonoscopyIUS/IBDNCT07115524
Comparative Accuracy of Activity Scores of Intestinal Ultrasound and Colonoscopy in Monitoring Ulcerative Colitis Activity
An observational study of AssessIUS Scores inUC Versus Colonoscopy, run by Assiut University at 1 site in Egypt.
Trial summary
Our study aimed to assess simple sonographic activity scores and Colonoscopy for active UC patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- AssessIUS Scores inUC Versus Colonoscopy
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: -Thorough medical history including abdominal pain, bloody diarrhea and its frequency, tensesmus,and mucous with stool, and physical examination (general and abdominal) stressing on fever, tachycardia, abdominal tenderness and significant weight loss. Each patient was phenotypically classified according to the Montreal classification (14). Harvey Bradshaw Index [HBI] (15) was used to assess clinical disease activity, where clinical remission was defined as HBI < 5. * Colonoscopy will done and assessment of severity according to Mayo Endoscopic Score (MES) for ulcerative colitis. * Intestinal ultrasound examination: * Patient preparation: no specific preparation needed but fasting 6-8 hours before examination decrease gaseous content and allow better visualization. * Calculate ultrasound activity scores (including Ulcerative Colitis-Intestinal Ultrasound Index (UC-IUS index), Simple IUS score).
Who may be able to join
- Any patient above age of 18 years old and diagnosed to have active UC through:
- Clinical features: rectal bleeding, with frequent stools and mucous discharge from the rectum. Some patients also describe tenesmus. The onset is typically insidious.
- Endoscopic findings include the following; loss of vascular pattern, Granular and fragile mucosa, friability, ulcerations, erosions, pseudo-polyposis
Who cannot join
- Patients with UC who are under age of 18 years' old.
- Pregnancy.
- Previous colectomy.
- Patient refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Our study aimed to assess simple sonographic activity scores and Colonoscopy for active UC patients
Read the detailed description
Ulcerative colitis (UC) has a relapsing-remitting course which necessitates frequent follow-up examinations to monitor disease activity.
Disease management was previously guided by patient reported symptoms, and treatment targets were based on symptom control. However, the patient's symptoms do not necessarily correspond to inflammatory activity and current guidelines recommend that management should be based on objective evaluations.
Ileocolonoscopy is considered the reference standard method for determining disease status in Ulcerative colitis. Although validated and reproducible scoring systems are complex and cumbersome to use in clinical practice, and even though ileocolonoscopy is an excellent tool for activity monitoring, it cannot be performed on a regular basis as it is invasive, is resourceintensive and causes considerable patient discomfort. As numerous follow-up examinations are required, simple non-invasive surrogate markers are needed.
Biomarkers such as C-reactive protein [CRP] and faecal calprotectin are well established in both primary work-up and disease monitoring.
Still, as they cannot depict disease location and have limited accuracy, additional tools are required.
Gastrointestinal ultrasound [GIUS] has high diagnostic accuracy for detecting active CD, and in trained hands, it can make significant impact on clinical decision-making.
Furthermore, as it is non-invasive, readily available and can be performed bedside, the modality seems well suited for bedside and frequent activity monitoring.
Still, interpretation of the GIUS findings may be influenced by the sonographer's level of experience. A standardized ultrasound activity index may simplify the interpretation of the sonographic findings, allowing for easier comparison between different examinations during follow-up. Although various sonographic activity scores are available, the methodology for development was shown to be insufficient in most studies and no index is in widespread clinical use.
- Conditions
- AssessIUS Scores inUC Versus Colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Simple Sonographic Activity Scores and Colonoscopy Findings in Active Ulcerative Colitis
To evaluate the relationship between intestinal ultrasound (IUS)-based sonographic activity scores and endoscopic disease activity assessed by colonoscopy in patients with active ulcerative colitis. The aim is to determine whether sonographic scoring can serve as a non-invasive surrogate for endoscopic assessment in monitoring disease activity.
Measured: At baseline (Day 0) from hospital admission
Assessment of Sonographic Activity Scores Compared to Colonoscopy in Active Ulcerative Colitis Patients
To evaluate the diagnostic accuracy and clinical relevance of simple intestinal ultrasound (IUS) activity scores in assessing disease activity in patients with active ulcerative colitis (UC), using colonoscopy findings as the reference standard.
Measured: At baseline (Day 0 of hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Oct 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AssessIUS Scores inUC Versus ColonoscopyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115524
- Sponsor's protocol ID
- 4-2025-300644
- Acronym
- IUS/IBD
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Accuracy of Activity Scores of Intestinal Ultrasound and Colonoscopy in Monitoring Ulcerative Colitis Activity
- ClinicalTrials.gov ID
- NCT07115524
- Acronym / sponsor ID
- IUS/IBD / 4-2025-300644
- Conditions
- AssessIUS Scores inUC Versus Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 11 Aug 2025 (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.
Our study aimed to assess simple sonographic activity scores and Colonoscopy for active UC patients
Detailed description
Ulcerative colitis (UC) has a relapsing-remitting course which necessitates frequent follow-up examinations to monitor disease activity.
Disease management was previously guided by patient reported symptoms, and treatment targets were based on symptom control. However, the patient's symptoms do not necessarily correspond to inflammatory activity and current guidelines recommend that management should be based on objective evaluations.
Ileocolonoscopy is considered the reference standard method for determining disease status in Ulcerative colitis. Although validated and reproducible scoring systems are complex and cumbersome to use in clinical practice, and even though ileocolonoscopy is an excellent tool for activity monitoring, it cannot be performed on a regular basis as it is invasive, is resourceintensive and causes considerable patient discomfort. As numerous follow-up examinations are required, simple non-invasive surrogate markers are needed.
Biomarkers such as C-reactive protein [CRP] and faecal calprotectin are well established in both primary work-up and disease monitoring.
Still, as they cannot depict disease location and have limited accuracy, additional tools are required.
Gastrointestinal ultrasound [GIUS] has high diagnostic accuracy for detecting active CD, and in trained hands, it can make significant impact on clinical decision-making.
Furthermore, as it is non-invasive, readily available and can be performed bedside, the modality seems well suited for bedside and frequent activity monitoring.
Still, interpretation of the GIUS findings may be influenced by the sonographer's level of experience. A standardized ultrasound activity index may simplify the interpretation of the sonographic findings, allowing for easier comparison between different examinations during follow-up. Although various sonographic activity scores are available, the methodology for development was shown to be insufficient in most studies and no index is in widespread clinical use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- -Thorough medical history including abdominal pain, bloody diarrhea and its frequency, tensesmus,and mucous with stool, and physical examination (general and abdominal) stressing on fever, tachycardia, abdominal tenderness and significant weight loss. Each patient was phenotypically classified according to the Montreal classification (14). Harvey Bradshaw Index [HBI] (15) was used to assess clinical disease activity, where clinical remission was defined as HBI < 5. * Colonoscopy will done and assessment of severity according to Mayo Endoscopic Score (MES) for ulcerative colitis. * Intestinal ultrasound examination: * Patient preparation: no specific preparation needed but fasting 6-8 hours before examination decrease gaseous content and allow better visualization. * Calculate ultrasound activity scores (including Ulcerative Colitis-Intestinal Ultrasound Index (UC-IUS index), Simple IUS score).
Key inclusion criteria (3 listed)
- Any patient above age of 18 years old and diagnosed to have active UC through:
- Clinical features: rectal bleeding, with frequent stools and mucous discharge from the rectum. Some patients also describe tenesmus. The onset is typically insidious.
- Endoscopic findings include the following; loss of vascular pattern, Granular and fragile mucosa, friability, ulcerations, erosions, pseudo-polyposis
Key exclusion criteria (4 listed)
- Patients with UC who are under age of 18 years' old.
- Pregnancy.
- Previous colectomy.
- 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.
Primary outcome
Correlation Between Simple Sonographic Activity Scores and Colonoscopy Findings in Active Ulcerative Colitis
Time frame: At baseline (Day 0) from hospital admission
To evaluate the relationship between intestinal ultrasound (IUS)-based sonographic activity scores and endoscopic disease activity assessed by colonoscopy in patients with active ulcerative colitis. The aim is to determine whether sonographic scoring can serve as a non-invasive surrogate for endoscopic assessment in monitoring disease activity.
Assessment of Sonographic Activity Scores Compared to Colonoscopy in Active Ulcerative Colitis Patients
Time frame: At baseline (Day 0 of hospital admission)
To evaluate the diagnostic accuracy and clinical relevance of simple intestinal ultrasound (IUS) activity scores in assessing disease activity in patients with active ulcerative colitis (UC), using colonoscopy findings as the reference standard.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AssessIUS Scores inUC Versus Colonoscopy, run by Assiut University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 5 Nov 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Simple Sonographic Activity Scores and Colonoscopy Findings in Active Ulcerative Colitis (time frame: At baseline (Day 0) from hospital admission). 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?
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 5 Nov 2026.