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Search / Trial NCT06271538

Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome

Launched by EP PLUS GROUP SDN BHD · Feb 14, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Probiotic Lactobacillus Plantarum 299v Randomized Controlled Study

ClinConnect Summary

This clinical trial is studying the effects of a product called Skål Pro Powder on people who have Irritable Bowel Syndrome (IBS). IBS is a common digestive condition that can cause symptoms like stomach pain, bloating, and changes in bowel habits. The goal of the trial is to see if Skål Pro Powder can help reduce these symptoms, improve how well stools form, enhance overall quality of life, and lessen any related anxiety or stress. Participants in the study will either receive Skål Pro Powder or a placebo (a substance with no active ingredients) without knowing which one they’re getting.

To be eligible for this trial, participants must be over 18 years old and have a confirmed diagnosis of IBS based on specific criteria. People with certain serious health issues, recent antibiotic use, or specific digestive problems will not be able to participate. If you join this study, you will be part of a group that is helping researchers understand how effective Skål Pro Powder can be for managing IBS symptoms. The trial is currently looking for participants, and everyone is welcome regardless of gender.

Gender

ALL

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™)

About Ep Plus Group Sdn Bhd

EP Plus Group Sdn Bhd is a leading clinical trial sponsor dedicated to advancing healthcare innovation through rigorous research and development. With a focus on enhancing patient outcomes, the company specializes in conducting high-quality clinical trials across various therapeutic areas. Leveraging a team of experienced professionals and robust methodologies, EP Plus Group Sdn Bhd is committed to ensuring compliance with regulatory standards while fostering collaboration with healthcare stakeholders. Their mission is to contribute to the global medical landscape by facilitating the development of safe and effective treatments.

Locations

Kubang Kerian, Kelantan, Malaysia

Patients applied

JE

1 patients applied

Trial Officials

Yeong Yeh Lee, MD, PhD

Principal Investigator

Hospital Universiti Sains Malaysia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported