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Tests treatment safety and results for Irritable Bowel Syndrome
Official title Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT06271538
What this study is testing
What is Skal Pro?
Skal Pro is an investigational medicine, being studied as a potential treatment for irritable bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- IBS diagnosed using the Rome IV criteria
- Age above 18 years old and any gender
- Any subtypes of IBS (diarrhea, constipation or mixed)
You likely can't join if
- 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
See the full eligibility criteria
- IBS diagnosed using the Rome IV criteria
- Age above 18 years old and any gender
- Any subtypes of IBS (diarrhea, constipation or mixed)
- 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™)
The study team makes the final eligibility decision.
Where it's taking place
- Kubang Kerian, Kelantan, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kubang Kerian, Kelantan, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.