Actively Recruiting
Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome
Led by Universiti Sains Malaysia · Updated on 2025-04-09
20
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
U
Universiti Sains Malaysia
Lead Sponsor
G
GenieBiome Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Irritable Bowel Syndrome (IBS) is a brain-gut-disorder characterized by a chronic relapsing-remitting nature of symptoms, including abdominal pain and altered bowel habits. Symptoms most likely result from complex interactions between several biological, psychological and social factors. Probiotic supplements are thought to improve IBS symptoms through manipulation of the gut microbiota. Some studies have suggested that different strains of probiotics may improve abdominal pain and reduce visceral hypersensitivity by modulation of expression of neurotransmitters and receptors involved in the modulation of pain, such as the opioid receptor or the cannabinoid receptor. In addition, probiotics have been shown to reduce intestinal cytokine secretion and improve epithelial barrier function in a mice model of intestinal inflammation. Bifidobacteria and Streptococci strains had previously demonstrated efficacy in achieving symptom improvement in IBS patients. Thus, there is potential for SMT04, a health supplement, to be an option for IBS patients.
CONDITIONS
Official Title
Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years old
- Diagnosed with diarrhoea-predominant or mixed subtype IBS, or functional diarrhoea meeting Rome-III criteria
- Abdominal pain or discomfort at least 3 days per month for last 3 months, starting at least 6 months ago
- Symptoms include improvement after defecation, or changes in stool frequency or consistency
- IBS-D subtype with more than 25% loose stools and less than 25% hard stools
- IBS-M subtype with at least 25% hard and lumpy stools and 25% loose stools
- Functional diarrhoea defined as loose or watery stools without pain in at least 75% of bowel movements for at least 3 months in last 6 months
- Negative colonoscopy within last 5 years
- Able to read and complete questionnaires
- Provided written informed consent
You will not qualify if you...
- Known inflammatory bowel disease, lactose intolerance, malabsorption syndromes, celiac disease, diabetes mellitus, thyroid dysfunction, cancer, immunodeficiency, autoimmune diseases, severe liver or kidney problems, or other explained causes of abdominal pain, diarrhoea, or constipation
- History of surgery involving small or large intestines, or appendectomy, hysterectomy, or cholecystectomy within last 6 months
- Severe mental illness or unstable psychiatric drug use in last 3 months affecting judgment
- Active infection at time of enrollment
- Use of prebiotics, probiotics, antibiotics, or anti-inflammatory drugs within last 2 weeks
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Actively Recruiting
Research Team
N
Nik Nur Athirah Rohazman Affandi
CONTACT
N
Nur Diyana Mohamed Hashim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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