A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)

Starting soon · Not applicable

Conditions studied: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)

In brief

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

Key facts

Study ID

NCT07411131

Run by

Chinese University of Hong Kong

People needed

50

Starts

2026-03-01

Expected to finish

2026-10-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Prince of Wales Hospital — Hong Kong, Hong Kong
• Prince of Wales Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.