Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06647043

A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 Pro in Irritable Bowel Syndrome (IBS)

Led by Universiti Sains Malaysia · Updated on 2025-04-09

20

Participants Needed

1

Research Sites

13 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 common disorder affecting the bowel, causing symptoms like abdominal pain and changes in bowel habits. This condition involves a complex interaction of biological, psychological, and social factors, and it can significantly reduce quality of life. Researchers are exploring new treatments to improve symptoms and quality of life for IBS patients, focusing on the role of gut bacteria. This trial studies SMT04 Pro, a dietary supplement containing a blend of probiotics including Bifidobacteria and Streptococci strains. Participants will take 2 sachets daily for 3 months. These probiotics are thought to potentially help by altering gut bacteria and reducing symptoms related to IBS. The study is open-label, meaning all participants receive SMT04 Pro without a comparison group. Participants will be assessed for IBS symptom severity using a scoring system at the start and after 3 months of treatment. Researchers will also track changes in gastrointestinal symptoms and monitor for safety. The involvement lasts for at least 3 months, during which participants complete questionnaires and other evaluations to measure treatment effects and well-being.

CONDITIONS

Brief Title

Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Aged from 18 to 70 years old
  • Meet the Rome-III definition of IBS with diarrhea or mixed subtypes, or functional diarrhea
  • Have abdominal pain or discomfort at least three days per month during the last three months starting at least six months ago
  • Have improvement of symptoms after defecation, or symptoms starting with changes in stool frequency or consistency
  • Subtype IBS-D with more than 25% loose stools and less than 25% hard stools, or IBS-M with stools both hard and loose at least 25% of the time
  • Functional diarrhea defined as loose or watery stools without pain in at least 75% of bowel movements for at least three months over the last six months
  • Have a negative colonoscopy result within the last five years
  • Literate and able to complete questionnaires
  • Provide written informed consent
Not Eligible

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 known causes of abdominal pain, diarrhea, or constipation
  • History of operations involving small or large intestines or appendectomy, hysterectomy, or cholecystectomy within the last six months
  • Severe mental illnesses or unstable psychiatric medication use within the last three months affecting judgment
  • Active infection at the time of inclusion
  • Use of prebiotics, probiotics, antibiotics, or anti-inflammatory drugs within the last two weeks
  • Current pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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 SMT04 Pro, a dietary supplement containing probiotics, twice daily to help improve IBS symptoms.

Monthly visits for monitoring and assessment

Trial Site Locations

Total: 1 location

1

Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia, 16150

Actively Recruiting

Loading map...

Research Team

N

Nik Nur Athirah Rohazman Affandi

N

Nur Diyana Mohamed Hashim

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

Similar Trials

The Role of Diet and Gastrointestinal Motility in Irritable ...

Irritable Bowel Syndrome (IBS)

Actively Recruiting

1 location

Evaluating the Added Benefit of Osteopathic Care to a Flexi-...

Irritable Bowel Syndrome (IBS)

Actively Recruiting

1 location

Exclude or Expose in Irritable Bowel Syndrome: What Works fo...

Irritable Bowel Syndrome (IBS)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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

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/24979556