A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)
Not applicable · Testing SGR11 synbiotic formula · 2 sites · Chinese University of Hong Kong
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing SGR11 synbiotic formula as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2026-03 (planned).
- Main results expected around 2026-09 (estimate from the record).
- 2 study sites listed in Hong Kong.
Main thing being measured
- Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I) (8 weeks after initiation of the study intervention)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC) |
| Lead sponsor | Chinese University of Hong Kong |
| Enrollment | 50 (estimated) |
| Start date | 2026-03 |
| Primary completion (est.) | 2026-09 |
| First posted | 2026-02-13 |
| Last updated | 2026-02-13 |
| Official title | A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD) |
| ClinicalTrials.gov ID | NCT07411131 |
Interventions
- SGR11 synbiotic formula (Other)
SGR11 is a synbiotic dietary supplement formulated to support gut microbial balance and intestinal health. It contains a combination of probiotic and prebiotic components designed to act synergistically to enhance microbial diversity, promote beneficial fermentation activity, and support mucosal barrier function. Participants will take the study product daily for 8 weeks. This formulation is disti…
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * Severe active IBD requiring hospitalization * Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome) * 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 * Known allergy or intolerance to study components * Inability to receive oral fluids * Participation in other interventional clinical trials within 30 days
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong | |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.