Ulcerative Colitis (UC)Phase 2/3NCT07820046
Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis
A Phase 2/3 study testing Nitazoxanide (NTZ) in people with Ulcerative Colitis (UC), run by Tanta University.
Trial summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Nitazoxanide (NTZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2028
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Confirmed ulcerative colitis ≥ 6 months
- Mild-to-moderate active disease (Mayo score 3-10)
- Stable UC therapy ≥ 8 weeks before enrollment Exclusion Criteria
- Severe/fulminant UC requiring hospitalization or surgery
- Active intestinal infection (e.g., C. difficile)
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- Antibiotics/probiotics/investigational drugs within 4 weeks
- Recent biologic initiation or dose change
- Severe hepatic, renal, cardiovascular disease, or malignancy
- Pregnancy or lactation
- Known hypersensitivity to nitazoxanide
Who cannot join
None listed.
About this study
Official title: Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance. Emerging evidence suggests that intestinal barrier dysfunction, microbiota dysbiosis, and immune dysregulation play central roles in UC pathogenesis.
Nitazoxanide is a broad-spectrum antiparasitic agent with demonstrated antimicrobial, anti-inflammatory, and immunomodulatory effects, including inhibition of NF-κB signaling and improvement of intestinal barrier integrity. Preclinical studies suggest potential benefit in experimental colitis models; however, clinical evidence remains limited.
This randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of nitazoxanide as an adjunct to standard therapy in patients with mild-to-moderate ulcerative colitis over a 12-week treatment period.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Nitazoxanide (NTZ)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitazoxanide (NTZ)Drug
Nitazoxanide 500 mg orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | : Placebo + Standard Therapy Standard ulcerative colitis therapy Placebo tablets twice daily fo Receives: Drug: Nitazoxanide (NTZ) |
| Arm 2: | Active comparator | Nitazoxanide + Standard Therapy Nitazoxanide 500 mg orally twice daily Standard ulcerative colitis therapy Duration: 12 weeks Receives: Drug: Nitazoxanide (NTZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis). The Mayo Score ranges from 0 to 12, with higher scores indicating worse disease activity. Therefore, a decrease in score represents clinical improvement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
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 Tanta 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Ahmed Mhrose Glal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820046
- Sponsor's protocol ID
- Nitazoxanide &UC
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 15 Sep 2026
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07820046
- Acronym / sponsor ID
- Nitazoxanide &UC
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 15 Sep 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.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance. Emerging evidence suggests that intestinal barrier dysfunction, microbiota dysbiosis, and immune dysregulation play central roles in UC pathogenesis.
Nitazoxanide is a broad-spectrum antiparasitic agent with demonstrated antimicrobial, anti-inflammatory, and immunomodulatory effects, including inhibition of NF-κB signaling and improvement of intestinal barrier integrity. Preclinical studies suggest potential benefit in experimental colitis models; however, clinical evidence remains limited.
This randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of nitazoxanide as an adjunct to standard therapy in patients with mild-to-moderate ulcerative colitis over a 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: Nitazoxanide (NTZ): Placebo + Standard Therapy Standard ulcerative colitis therapy Placebo tablets twice daily fo |
| Arm 2: | Active comparator | Drug: Nitazoxanide (NTZ)Nitazoxanide + Standard Therapy Nitazoxanide 500 mg orally twice daily Standard ulcerative colitis therapy Duration: 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-65 years
- Confirmed ulcerative colitis ≥ 6 months
- Mild-to-moderate active disease (Mayo score 3-10)
- Stable UC therapy ≥ 8 weeks before enrollment Exclusion Criteria
- Severe/fulminant UC requiring hospitalization or surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nitazoxanide (NTZ)Nitazoxanide 500 mg orally twice daily | Drug | Arm 1, Arm 2: |
Primary outcome
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)
Time frame: 12 weeks
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis). The Mayo Score ranges from 0 to 12, with higher scores indicating worse disease activity. Therefore, a decrease in score represents clinical improvement.
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nitazoxanide (NTZ) in people with Ulcerative Colitis (UC), run by Tanta 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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 15 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis) (time frame: 12 weeks). 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 15 Sep 2026.