Evaluating SMT04 for treating Irritable Bowel Syndrome
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
This study is testing a new probiotic called SMT04 to see if it can help people with Irritable Bowel Syndrome feel better by improving their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Changi General Hospital Academic / other |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT06636513 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of SMT04, a novel probiotic supplement, on patients with Irritable Bowel Syndrome (IBS). The study aims to determine how SMT04 can modulate gut microbiota and improve IBS symptoms by using the Rome III diagnostic criteria. Participants will receive SMT04 and their IBS-related scores and gut microbiome changes will be monitored over time. The trial focuses on understanding the optimal composition of probiotics for symptom relief in IBS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 70 who meet the Rome III criteria for IBS with diarrhea or mixed subtypes.
Not a fit: Patients with IBS subtypes that do not involve diarrhea or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from IBS by alleviating their symptoms.
How similar studies have performed: Previous studies have shown that varying compositions of probiotics can improve IBS symptoms, suggesting that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged from 21 years to 70 years old * Meet the criteria of the Rome-III-definition of IBS with diarrhoea or mixed subtypes, or functional diarrhoea Rome-III-definition: Abdominal pain or abdominal discomfort on minimum of three days per month during the last three months, starting at least six months ago, and a minimum of two of the following criteria: * Improvement of symptoms after defecation * Start of symptoms in association with a change in stool frequency * Start of symptoms in association with a change in stool consistency Subtype of IBS-D which requires more than 25% of the participant's stools to be loose and less than 25% hard and lumpy; subtype of IBS-M which the participant's stools must be both hard and lumpy, as well as loose in consistency at least 25% of the time. Functional diarrhoea: The experience of loose or watery stools without pain occurring in at least 75% of bowel movements for at least three months over the last six months. * Have the latest negative colonoscopy result within five years * Literate and can complete questionnaire * Written informed consent is obtained Exclusion Criteria: * Known inflammatory bowel disease, lactose intolerance or other malabsorption syndromes, celiac disease, diabetes mellitus, thyroid dysfunction, cancer, immunodeficiency, autoimmune diseases, severe hepatic or renal insufficiency, other explainable causes of abdominal pain, diarrhoea or constipation * Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months. * Known severe mental illnesses; unstable type or dose of psychiatric drugs within the last 3 months that will affect their judgement of study participation. * Evidence of active infection at the time of inclusion * History of use of prebiotics, probiotics, antibiotic therapy or anti-inflammatory drugs within the last 2 weeks * Known current pregnancy or breast-feeding female
Where this trial is running
Singapore, Singapore
- Dr Daphne Ang Shih Wen — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Daphne Shih Wen Ang — Changi General Hospital
- Study coordinator: Chun Feng Tao
- Email: Chunfeng_Tao@cgh.com.sg
- Phone: +65-64267815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.