NCT06271538 Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
| NCT ID | NCT06271538 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | EP Plus Group Sdn Bhd |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-10-17 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.
Eligibility Criteria
Inclusion Criteria: * IBS diagnosed using the Rome IV criteria * Age above 18 years old and any gender * Any subtypes of IBS (diarrhea, constipation or mixed) Exclusion Criteria: * Presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal mass, strong family history of cancer) * Was prescribed antibiotic (s) within the past one month * Medical conditions that contraindicate probiotic use including severe sepsis and pregnancy * Presence of bowel malignancy * Diagnosis of bowel infection within the past one month * Previous abdominal surgeries * Patients with overt psychiatric illnesses including schizophrenia and manic disorders * A history of allergy to probiotic * Was prescribed probiotic (s) within the past one month * Was previously prescribed probiotic Skal Pro™ (LP299V™)
Contact & Investigator
Yeong Yeh Lee, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Universiti Sains Malaysia
Frequently Asked Questions
Who can join the NCT06271538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06271538 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06271538 currently recruiting?
Yes, NCT06271538 is actively recruiting participants. Contact the research team at jonathankhor@epplusgroup.com for enrollment information.
Where is the NCT06271538 trial being conducted?
This trial is being conducted at Kubang Kerian, Malaysia.
Who is sponsoring the NCT06271538 clinical trial?
NCT06271538 is sponsored by EP Plus Group Sdn Bhd. The principal investigator is Yeong Yeh Lee, MD, PhD at Hospital Universiti Sains Malaysia. The trial plans to enroll 60 participants.