Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating.
Elham Jafari, Homayoon Vahedi, Shahin Merat...
https://pubmed.ncbi.nlm.nih.gov/24979556Actively Recruiting
Phase Not Applicable
Age: 21Years - 55Years
All Genders
ID06636513
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
Led by Changi General Hospital · Updated on 2025-02-12
40
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
C
Changi General Hospital
Lead Sponsor
G
GenieBiome Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying irritable bowel syndrome (IBS) and how probiotic supplements can improve symptoms by changing the gut microbiota. This trial focuses on SMT04, a dietary supplement containing a blend of five probiotics, including Bifidobacteria and Streptococci strains. The study aims to understand how SMT04 affects gut bacteria and IBS symptoms, using the Rome III criteria for diagnosis. This is a pilot, single-arm, open-label trial conducted at multiple centers, pooling data for analysis. Participants will take one sachet of SMT04 daily for three months. The study will track changes in gut microbiota and IBS symptoms throughout this period. This trial does not include a control group or placebo; all participants receive the probiotic supplement to assess its potential effects. During the study, participants will undergo evaluations including gut microbiome analysis using tools like the Shannon index and principal coordinate analysis. IBS symptoms will be measured using the IBS severity scoring system and gastrointestinal symptom assessments. Researchers will monitor changes from baseline to three months, focusing on microbiota composition and symptom improvement. The study runs from March 2024 until December 2026.
CONDITIONS
Brief Title
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
Who Can Participate
Age: 21Years - 55Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 21 to 70 years old
- Diagnosed with IBS using Rome III criteria with diarrhoea or mixed subtypes, or functional diarrhoea
- Latest negative colonoscopy within the past 5 years
- Able to read and complete questionnaires
- Provided written informed consent
You will not qualify if you...
- History of inflammatory bowel disease, lactose intolerance, malabsorption syndromes, celiac disease, diabetes, thyroid dysfunction, cancer, immunodeficiency, autoimmune diseases, severe liver or kidney problems, or other causes of abdominal symptoms
- Recent surgeries involving the intestines, appendectomy, hysterectomy, or gallbladder removal within the last 6 months
- Severe mental illness or unstable psychiatric medication use in the past 3 months
- Active infection at the time of study entry
- Use of prebiotics, probiotics, antibiotics, or anti-inflammatory drugs within the last 2 weeks
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants take 1 sachet of SMT04 daily as a probiotic supplement to improve IBS symptoms and modulate gut microbiota.
Monthly visits for 3 months
Trial Site Locations
Total: 1 location
1
Dr Daphne Ang Shih Wen
Singapore, Singapore, Singapore, 529889
Actively Recruiting
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Research Team
C
Chun Feng Tao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.
Valerio Mezzasalma, Enrico Manfrini, Emanuele Ferri...
https://pubmed.ncbi.nlm.nih.gov/27595104