Chronic Spontaneous Urticaria (CSU)NCT07431658
Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
An observational study of Chronic Spontaneous Urticaria (CSU), run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU)
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with active CSU and age/BMI-matched healthy volunteers
Who may be able to join
- Age 18-65 years
- CSU group: diagnosis of chronic spontaneous urticaria, active CSU, and written informed consent
- Control group: healthy volunteers with similar characteristics (age/BMI-matched)
Who cannot join
- Additional dermatologic, metabolic, endocrinologic, systemic inflammatory disease; malignancy (diagnosis or suspicion)
- Use within last 3 months of anti-inflammatory drugs or drugs that may affect serum glucose/lipids
- Special diet/nutrition status; antioxidant supplement use
- Smoking or alcohol use
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital, Dermatology and Venereology Clinic Cerrahpaşa Mh. Org. Abdurrahman Nafiz Gürman Cd. No:24, 34098 Fatih, Istanbul, Turkey
Istanbul, 34098
About this study
Official title: Investigation of the Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab Treatment in Patients With Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.
Read the detailed description
This is an observational, case-control study including 58 adults (18-65 years) with active chronic spontaneous urticaria recruited from a dermatology outpatient clinic and 58 age- and BMI-matched healthy volunteers. Demographic/clinical data and comorbidities will be recorded. Dietary intake will be captured using three non-consecutive 24-hour food consumption records (two weekdays, one weekend day). Food portions will be estimated using a standardized food photo catalogue and analyzed with BeBiS 9.0 to compute macro/micronutrients, glycemic index/load, and dietary antioxidant capacity using ORAC. Venous blood will be used to measure total oxidant status (TOS/TOK), total antioxidant status (TAS/TAK), advanced oxidation protein products (AOPP), and malondialdehyde (MDA), and to calculate oxidative stress index (OSI). In CSU patients, disease activity will be evaluated using UAS7 and the Urticaria Control Test (UCT), as well as an urticaria quality of life questionnaire. CSU patients with a clinical indication for omalizumab will be re-evaluated after 3 months, repeating dietary records, biomarker measurements, and clinical scores to assess treatment response.
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Keywords
- Chronic spontaneous urticaria, oxidative stress, dietary antioxidant capacity, omalizumab, UAS7, UCT, AOPP, MDA, total oxidant status, total antioxidant status, OSI, ORAC
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Chronic Spontaneous Urticaria (CSU) Patients | 58 adults with active CSU | |
| Cohort 2: Healthy Controls | 58 healthy volunteers matched by age and BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity scores (UAS7, UCT) and urticaria quality of life questionnaire (CU-Q2oL)
Disease activity and control will be assessed in CSU patients only using the Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT).
Quality of life will be assessed in CSU patients only using an urticaria quality of life questionnaire (CU-Q2oL)
Measured: Baseline
Oxidative stress biomarkers (TOK, TAK, AOPP, MDA; OSI calculated)
From routine venous blood samples, Total Oxidant Capacity (TOK), Total Antioxidant Capacity (TAK), Advanced Oxidation Protein Products (AOPP), and Malondialdehyde (MDA) will be measured; Oxidative Stress Index (OSI) will be calculated as the TOK/TAK ratio.
Measured: Baseline
Dietary intake / dietary antioxidant capacity based on 3-day dietary record
Dietary intake will be captured using three non-consecutive 24-hour dietary records (two weekdays, one weekend day). Dietary antioxidant capacity will be calculated using Oxygen Radical Absorbance Capacity (ORAC) with BeBiS 9.0 (Nutrition Information System).
Measured: Baseline
Secondary outcomes (2)
Change in urticaria disease activity score (UAS7: Urticaria Activity Score over 7 days), urticaria control (UCT: Urticaria Control Test) and urticaria-related quality of life questionnaire score (CU-Q2oL)
All participants in the chronic spontaneous urticaria (CSU) patient group will initiate omalizumab (standard-of-care) and change in UAS7, UCT, CU-Q2oL will be reassessed after 3 months following omalizumab treatment
Measured: Baseline to 3 months (after initiation of omalizumab)
Change in oxidative stress biomarkers in venous blood (TOK, TAK, AOPP, MDA, OSI)
Change in Total Oxidant Capacity (TOK), Total Antioxidant Capacity (TAK), Advanced Oxidation Protein Products (AOPP), Malondialdehyde (MDA) and calculated Oxidative Stress Index (OSI) in chronic spontaneous urticaria (CSU) patient group from baseline to Month 3 after initiate omalizumab
Measured: Baseline to 3 months after initiation of omalizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Ecem Hakkoymaz, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431658
- Sponsor's protocol ID
- SBU-IEAH-KAEK-20251205-294
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab Treatment in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07431658
- Acronym / sponsor ID
- SBU-IEAH-KAEK-20251205-294
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Keywords
- Chronic spontaneous urticaria, oxidative stress, dietary antioxidant capacity, omalizumab, UAS7, UCT, AOPP, MDA
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Feb 2026 (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.
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.
Detailed description
This is an observational, case-control study including 58 adults (18-65 years) with active chronic spontaneous urticaria recruited from a dermatology outpatient clinic and 58 age- and BMI-matched healthy volunteers. Demographic/clinical data and comorbidities will be recorded. Dietary intake will be captured using three non-consecutive 24-hour food consumption records (two weekdays, one weekend day). Food portions will be estimated using a standardized food photo catalogue and analyzed with BeBiS 9.0 to compute macro/micronutrients, glycemic index/load, and dietary antioxidant capacity using ORAC. Venous blood will be used to measure total oxidant status (TOS/TOK), total antioxidant status (TAS/TAK), advanced oxidation protein products (AOPP), and malondialdehyde (MDA), and to calculate oxidative stress index (OSI). In CSU patients, disease activity will be evaluated using UAS7 and the Urticaria Control Test (UCT), as well as an urticaria quality of life questionnaire. CSU patients with a clinical indication for omalizumab will be re-evaluated after 3 months, repeating dietary records, biomarker measurements, and clinical scores to assess treatment response.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Chronic Spontaneous Urticaria (CSU) Patients | – | –58 adults with active CSU |
| Cohort 2: Healthy Controls | – | –58 healthy volunteers matched by age and BMI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with active CSU and age/BMI-matched healthy volunteers
Key inclusion criteria (3 listed)
- Age 18-65 years
- CSU group: diagnosis of chronic spontaneous urticaria, active CSU, and written informed consent
- Control group: healthy volunteers with similar characteristics (age/BMI-matched)
Key exclusion criteria (5 listed)
- Additional dermatologic, metabolic, endocrinologic, systemic inflammatory disease; malignancy (diagnosis or suspicion)
- Use within last 3 months of anti-inflammatory drugs or drugs that may affect serum glucose/lipids
- Special diet/nutrition status; antioxidant supplement use
- Smoking or alcohol use
- Pregnant or breastfeeding
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
Disease activity scores (UAS7, UCT) and urticaria quality of life questionnaire (CU-Q2oL)
Time frame: Baseline
Disease activity and control will be assessed in CSU patients only using the Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT). Quality of life will be assessed in CSU patients only using an urticaria quality of life questionnaire (CU-Q2oL)
Oxidative stress biomarkers (TOK, TAK, AOPP, MDA; OSI calculated)
Time frame: Baseline
From routine venous blood samples, Total Oxidant Capacity (TOK), Total Antioxidant Capacity (TAK), Advanced Oxidation Protein Products (AOPP), and Malondialdehyde (MDA) will be measured; Oxidative Stress Index (OSI) will be calculated as the TOK/TAK ratio.
Dietary intake / dietary antioxidant capacity based on 3-day dietary record
Time frame: Baseline
Dietary intake will be captured using three non-consecutive 24-hour dietary records (two weekdays, one weekend day). Dietary antioxidant capacity will be calculated using Oxygen Radical Absorbance Capacity (ORAC) with BeBiS 9.0 (Nutrition Information System).
2 secondary outcomes
Change in urticaria disease activity score (UAS7: Urticaria Activity Score over 7 days), urticaria control (UCT: Urticaria Control Test) and urticaria-related quality of life questionnaire score (CU-Q2oL)
Time frame: Baseline to 3 months (after initiation of omalizumab)
Change in oxidative stress biomarkers in venous blood (TOK, TAK, AOPP, MDA, OSI)
Time frame: Baseline to 3 months after initiation of omalizumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
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 Chronic Spontaneous Urticaria (CSU), run by Istanbul Training and Research Hospital 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Disease activity scores (UAS7, UCT) and urticaria quality of life questionnaire (CU-Q2oL) (time frame: Baseline). The study lists 3 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 27 Feb 2026.