Inflammatory Bowel Disease (IBD)NCT07411131
A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)
A study testing SGR11 synbiotic formula in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
- What is being tested?
- SGR11 synbiotic formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesHong Kong
- Study dates
- Mar 2026to Oct 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Alicia Chan, +852 26373260, aliciachan@cuhk.edu.hk
Siew Chien Ng
About this study
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?
Read more
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
Read the detailed description
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is characterized by chronic relapsing inflammation of the gastrointestinal tract driven by dysregulated immune responses to intestinal microbiota. Extensive evidence demonstrates that IBD is associated with marked gut microbiota dysbiosis, including loss of key short-chain fatty acid (SCFA)-producing taxa and enrichment of pro-inflammatory or mucosa-associated organisms. These microbial alterations contribute to impaired epithelial barrier integrity, shifts in microbial metabolite profiles, activation of mucosal immune pathways, and increased susceptibility to persistent intestinal inflammation. Additionally, IBS-like symptoms remain common among individuals with IBD, even during clinical remission, indicating ongoing functional and microbiota-related disturbances not fully addressed by conventional therapies.
Synbiotics, which combine probiotic and prebiotic components in a synergistic formulation, represent a promising therapeutic strategy targeting microbial and mucosal mechanisms relevant to IBD. Components within SGR11 have demonstrated potential in preclinical and clinical research to modulate intestinal inflammation, enhance epithelial barrier function, influence T-cell-mediated immune responses, improve microbial fermentation profiles, and support restoration of gut microbiota homeostasis. Prebiotic elements within synbiotic formulations may further promote beneficial microbial activity, reinforce mucosal structural integrity, and modulate host immune responses.
This pilot, single-arm clinical trial will evaluate the safety and preliminary efficacy of SGR11 over an 8-week intervention period in adults with IBD. The study will assess global clinical improvement, symptom indices, patient-reported outcomes, biochemical markers of intestinal inflammation and permeability, and gut microbiome composition and functional characteristics using stool-based assays
- Being tested
- SGR11 synbiotic formula
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis, Synbiotic
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGR11 synbiotic formulaOther
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 distinguished by its specific synbiotic composition and its intended effects on gut microbiota-related pathways relevant to inflammatory bowel disease.
| Study group | Role | What they receive |
|---|---|---|
| SGR11 Synbiotic Formula Arm | Experimental | Participants in this arm will receive the synbiotic formula SGR11 for an 8-week intervention period. All participants will take the study product as directed and complete scheduled assessments, including symptom questionnaires, stool sample collection for microbiome and biomarker analysis, and safety monitoring throughout the study. Receives: Other: SGR11 synbiotic formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I)
Overall clinical improvement will be assessed using the Clinical Global Impression - Improvement scale (CGI-I), a clinician-rated measure evaluating change in a participant's condition relative to baseline.
Measured: 8 weeks after initiation of the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411131
- Sponsor's protocol ID
- IBD Synbiotic
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IBD Synbiotic
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis, Synbiotic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 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.
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
Detailed description
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is characterized by chronic relapsing inflammation of the gastrointestinal tract driven by dysregulated immune responses to intestinal microbiota. Extensive evidence demonstrates that IBD is associated with marked gut microbiota dysbiosis, including loss of key short-chain fatty acid (SCFA)-producing taxa and enrichment of pro-inflammatory or mucosa-associated organisms. These microbial alterations contribute to impaired epithelial barrier integrity, shifts in microbial metabolite profiles, activation of mucosal immune pathways, and increased susceptibility to persistent intestinal inflammation. Additionally, IBS-like symptoms remain common among individuals with IBD, even during clinical remission, indicating ongoing functional and microbiota-related disturbances not fully addressed by conventional therapies.
Synbiotics, which combine probiotic and prebiotic components in a synergistic formulation, represent a promising therapeutic strategy targeting microbial and mucosal mechanisms relevant to IBD. Components within SGR11 have demonstrated potential in preclinical and clinical research to modulate intestinal inflammation, enhance epithelial barrier function, influence T-cell-mediated immune responses, improve microbial fermentation profiles, and support restoration of gut microbiota homeostasis. Prebiotic elements within synbiotic formulations may further promote beneficial microbial activity, reinforce mucosal structural integrity, and modulate host immune responses.
This pilot, single-arm clinical trial will evaluate the safety and preliminary efficacy of SGR11 over an 8-week intervention period in adults with IBD. The study will assess global clinical improvement, symptom indices, patient-reported outcomes, biochemical markers of intestinal inflammation and permeability, and gut microbiome composition and functional characteristics using stool-based assays
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGR11 Synbiotic Formula Arm | Experimental | Other: SGR11 synbiotic formulaParticipants in this arm will receive the synbiotic formula SGR11 for an 8-week intervention period. All participants will take the study product as directed and complete scheduled assessments, including symptom questionnaires, stool sample collection for microbiome and biomarker analysis, and safety monitoring throughout the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| SGR11 synbiotic formulaSGR11 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 distinguished by its specific synbiotic composition and its intended effects on gut microbiota-related pathways relevant to inflammatory bowel disease. | Other | SGR11 Synbiotic Formula Arm |
Primary outcome
Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I)
Time frame: 8 weeks after initiation of the study intervention
Overall clinical improvement will be assessed using the Clinical Global Impression - Improvement scale (CGI-I), a clinician-rated measure evaluating change in a participant's condition relative to baseline.
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 13 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGR11 synbiotic formula in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 6 inclusion and 10 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 13 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 2 sites in Hong Kong. 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?
Contact Alicia Chan (+852 2637 3260, aliciachan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants demonstrating overall clinical improvement at 8 weeks (CGI-I) (time frame: 8 weeks after initiation of the study intervention). 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 13 Feb 2026.