Evaluating the effects of synbiotics on irritable bowel syndrome
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 Pro in Irritable Bowel Syndrome (IBS)
This study is testing if a special mix of probiotics and prebiotics can help people with Irritable Bowel Syndrome feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Kubang Kerian, Kelantan) |
| Trial ID | NCT06647043 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of synbiotics in alleviating symptoms of Irritable Bowel Syndrome (IBS), a condition characterized by abdominal pain and altered bowel habits. Participants will be individuals aged 18 to 70 who meet the Rome-III criteria for IBS with diarrhea or mixed subtypes. The intervention involves administering a specific synbiotic formulation, SMT04 Pro, to assess its impact on symptom relief and quality of life. The study seeks to explore the potential of synbiotics to modulate gut microbiota and improve gastrointestinal health in IBS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 who have been diagnosed with IBS-D or IBS-M according to the Rome-III criteria.
Not a fit: Patients with IBS subtypes other than diarrhea or mixed, or those outside the age range of 18 to 70, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for patients suffering from IBS, potentially improving their symptoms and quality of life.
How similar studies have performed: Other studies have shown promising results with synbiotics in improving IBS symptoms, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* The subject must meet all of the inclusion criteria to participate in this study.
* Male or female,
* Aged from 18 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 your stools to be loose and less than 25% hard and lumpy; Subtype of IBS-M which your 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 disfunction, 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
Kubang Kerian, Kelantan
- Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (Recruiting)
Study contacts
- Principal investigator: Yeong Yeh Lee — Universiti Sains Malaysia
- Study coordinator: Nik Nur Athirah Rohazman Affandi
- Email: athirahaffandi22@gmail.com
- Phone: +601161203432
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.