Ulcerative Colitis (UC)NCT07236333
The Role of CALLY and HAALP in Ulcerative Colitis
An observational study of Ulcerative Colitis (UC), run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to demonstrate the type and amount of retention in the colon during ulcerative colitis activation, as well as the relationship between C-reactive protein (CRP), albumin and the calculated CALLY index. The investigators also aim to establish whether this ratio can be used to indicate activation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- CALLY and HALP
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ulserative colitis patients
Who may be able to join
- under 18
Who cannot join
- no UC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of CALLY and HAALP Scores in the Evaluation of Ulcerative Colitis Attack
The aim of this study is to demonstrate the type and amount of retention in the colon during ulcerative colitis activation, as well as the relationship between C-reactive protein (CRP), albumin and the calculated CALLY index. The investigators also aim to establish whether this ratio can be used to indicate activation.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- CALLY, HALP
- Keywords
- Ulcerative Colitis, CALLY, HAALP
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALLYDiagnostic test
The CALLY index, integrating C-reactive protein (CRP), albumin, and lymphocyte count, has been identified as a promising prognostic biomarker.
HALPDiagnostic test
The HALP score is calculated as HALP Score = [hemoglobin (g/L) × albumin (g/L) × lymphocytes (/L)]/platelets (/L). It is a definitive biomarker.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patients' HALP Score
Ulcerative colitis patients will be evaluated by evaluating the Change in HALP Score and its effect on prognosis.
Measured: through study completion, an average of 1 year
Change in Patients' CALLY Index Score
Ulcerative colitis patients will be evaluated by evaluating the Change in CALLY Index Score and its effect on prognosis.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jun 2020
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Ataturk 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Principal investigator, okkes zortuk, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236333
- Sponsor's protocol ID
- ZTKLAB30012025TBAEK121GASTROEN
- Other IDs
- TBAEK-121
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CALLY and HAALP Scores in the Evaluation of Ulcerative Colitis Attack
- ClinicalTrials.gov ID
- NCT07236333
- Acronym / sponsor ID
- ZTKLAB30012025TBAEK121GASTROEN
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis, CALLY, HAALP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Nov 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.
The aim of this study is to demonstrate the type and amount of retention in the colon during ulcerative colitis activation, as well as the relationship between C-reactive protein (CRP), albumin and the calculated CALLY index. The investigators also aim to establish whether this ratio can be used to indicate activation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ulserative colitis patients
Key inclusion criteria (1 listed)
- under 18
Key exclusion criteria (1 listed)
- no UC
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 |
|---|---|---|
| CALLYThe CALLY index, integrating C-reactive protein (CRP), albumin, and lymphocyte count, has been identified as a promising prognostic biomarker. | Diagnostic test | – |
| HALPThe HALP score is calculated as HALP Score = [hemoglobin (g/L) × albumin (g/L) × lymphocytes (/L)]/platelets (/L). It is a definitive biomarker. | Diagnostic test | – |
Primary outcome
Change in Patients' HALP Score
Time frame: through study completion, an average of 1 year
Ulcerative colitis patients will be evaluated by evaluating the Change in HALP Score and its effect on prognosis.
Change in Patients' CALLY Index Score
Time frame: through study completion, an average of 1 year
Ulcerative colitis patients will be evaluated by evaluating the Change in CALLY Index Score and its effect on prognosis.
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 19 Nov 2025.
- 1\. Further research on the clinical relevance of the ulcerative colitis colonoscopic index of severity for predicting 5-year relapseLink provided by the sponsor.
- 2\. Validation of a novel integral disease index for evaluating the grade of activity in Mexican patients with ulcerative colitis: A prospective cohort studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Ulcerative Colitis (UC)
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
Enrolling by invitationPhase 4
INSIGHT-IBD Pragmatic Study
Ulcerative Colitis (UC), Crohn Disease (CD)
Not yet recruitingPhase 4
Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose
Ulcerative Colitis (UC)
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 Ulcerative Colitis (UC), run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 19 Nov 2025. 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 Turkey (Türkiye). 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?
Change in Patients' HALP Score (time frame: through study completion, an average of 1 year). 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 19 Nov 2025.