Confirmatory Clinical Study in Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT07296315. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.
Study identification
- NCT ID
- NCT07296315
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 204 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2026 (Actual)
- Primary completion
- Sep 2027 (Estimated)
- Completion
- May 2028 (Estimated)
- Last update posted
- Oct 21, 2026
2026 – 2028
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ARA Professionals | Miami | Florida | 33155 | Recruiting |
| Orlando Gastroenterology, P.A. | Orlando | Florida | 32835 | Recruiting |
| Tropical Clinical Trials | Palmetto Bay | Florida | 33176 | Recruiting |
| Cross Creek Medical Clinic | Fayetteville | North Carolina | 28304 | Recruiting |
| Peters Medical Research | High Point | North Carolina | 27260 | Recruiting |
| Southern Star Research Institute | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07296315, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07296315 live on ClinicalTrials.gov.