NCT07411131Not yet recruiting
A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
The goal of this clinical trial is to find out whether a synbiotic formula (SGR11) can improve symptoms and health measures in people with inflammatory bowel disease (IBD). The main questions it aims to answer are: * Does SGR11 lead to overall improvement in a participant's condition after 8 weeks, as measured by the Clinical Global Impression-Improvement Scale (CGI I)? * Is SGR11 safe and well tolerated in people with IBD? Participants will: * Take the study synbiotic formula (SGR11) daily for 8 weeks * Complete symptom and quality of life questionnaires * Provide stool samples and, if applicable, blood samples to measure inflammation and gut microbiome changes * Report any side effects that occur during the study
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- Mar 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Ulcerative colitis
- NCT number
- NCT07411131
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Mar 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome)
- Known allergy or intolerance to study components
Other
- Severe active IBD requiring hospitalization
- Presence of an ileostomy or colostomy
- Severe comorbidities or immunocompromised states
- Known current sepsis
- Recent use of antibiotics, probiotics, or prebiotics within 4 weeks
- Known pregnancy or breastfeeding
- Inability to receive oral fluids
- Participation in other interventional clinical trials within 30 days
Who the study is looking for
- Individuals aged between 18-75
- Chinese ethnicity
- Confirmed diagnosis of ulcerative colitis (UC) with mild to moderate disease activity, defined as a Simple Clinical Colitis Activity Index (SCCAI) of 3-5
- On stable doses of IBD medication for ≥4 weeks prior to enrolment
- Ability to provide written informed consent
- Willingness to comply with study procedures
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.