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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SGR11 synbiotic formula

Treatment groups

50 Participants
are divided into 1 treatment group