Irritable Bowel SyndromePhase 4NCT06271538
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
A Phase 4 study testing Skal Pro in people with Irritable Bowel Syndrome and Gastrointestinal Diseases, run by EP Plus Group Sdn Bhd at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional
- What is being tested?
- Skal Pro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Oct 2024to 14 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS diagnosed using the Rome IV criteria
- Age above 18 years old and any gender
- Any subtypes of IBS (diarrhea, constipation or mixed)
Who cannot join
- 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
Show all 10Show fewer
- 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™)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official title: A Randomized Double-Blind Placebo-controlled Clinical Trial on the Efficacy of Skål Pro (Lactobacillus Plantarum 299 and Galacto-oligosaccharides) in Improving Severity of Symptoms, Stool Forms, Quality of Life and Psychological Dysfunction in Patients With Irritable Bowel Syndrome (IBS)
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.
Read the detailed description
Irritable bowel syndrome (IBS) is a condition linked to disturbances in the gut-brain axis and dysbiosis. Although probiotic modulation of dysbiosis appears promising for IBS treatment, identifying the specific beneficial strains remains uncertain. Furthermore, even with an effective probiotic strain, variations in efficacy among populations are observed due to environmental heterogeneity, particularly dietary influences.
This study seeks to provide efficacy insights into Skal Pro powder 2g (containing Lactobacillus plantarum 299v 1x10^10 colony forming unit (CFU) and GOS), shedding light on the unique mechanisms of LP299V within the Malaysian population through a randomized controlled trial (RCT).
- Conditions
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Disease, Digestive System Disease, Pathologic Processes
- Being tested
- Skal Pro, Placebo
- Keywords
- probiotic, Lactobacillus plantarum 299v, randomized controlled study
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Diseases, Digestive System Diseases, Pathologic Processes, Colonic Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skal ProCombination product
One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10^10 CFU and GOS
PlaceboOther
One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet
| Study group | Role | What they receive |
|---|---|---|
| Skal Pro | Experimental | Skal Pro in the form of 2g sachet powder contains 10 billion CFU of freeze-dried Lactobacillus plantarum 299v (LP299V) and galactooligosaccharides (GOS). Receives: Combination Product: Skal Pro |
| Placebo | Placebo comparator | Placebo is an oral formulation of inert powder. Placebo and Skal Pro are identical in shape, size, colour, packaging and taste. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
IBSSS questionnaire contains five questions that measures, on a 100-point visual analogue scale (VAS), the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life (QOL). All five components contribute to the scores equally, yielding a theoretically range of 0 - 500, with a higher score indicating worse condition. The Malay version questionnaire will be used.
Measured: Assessed at baseline, Week 1, Week 2, and Week 4.
Secondary outcomes (6)
Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary
Daily diary of stool consistency of each bowel movement based on Bristol Stool Scale (Type 1-7), from type 1-2 = separate hard lump stool, type 3-4= ideal stool, type 5-7 =loose stool
Measured: Assessed daily from baseline to Week 4.
Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary
Daily diary of number of bowel movements.
Measured: Assessed daily from baseline to Week 4.
Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)
Originally developed by Thiwan et al., this research group then translated and validated the BSQ in the Malay language (BSQ-M) [13]. There are 2 sub-scales, the 6-item Sev-Gen (Severity-General) and 5-item Sev-24 (Severity-24 hour) with responses in seven-point Likert scale on different degree of severity (from 1 = never to 7=always). For this study, only the Sev-Gen will be used.
Measured: Assessed at baseline, Week 1, Week 2, and Week 4.
Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire
The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009, and consist of 2 sections, 1) the EQ-5D descriptive system and 2) the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health the participant can imagine' and 'The worst health the participant can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. The Malay version questionnaire will be used.
Measured: Assessed at baseline, Week 1, Week 2, and Week 4.
Change in Visceral Sensitivity Index
The Visceral Sensitivity Index (VSI) is a 15-item questionnaire which measures gastrointestinal symptom-specific anxiety. Replies to each item are provided on a 6-point scale from "strongly disagree" (scored as 0) to "strongly agree" (scored as 5). A Malay version of the questionnaire was developed using standard forward-back translation procedures. The Malay version questionnaire will be used.
Measured: Assessed at baseline, Week 1, Week 2, and Week 4.
Assessment of psychological dysfunction suing Catastrophizing Questionnaire
The Coping Strategies Questionnaire (CSQ) - Catastrophizing (CAT) subscale consists of six questions on a 6-point Likert scale, with response options ranging from 0 (never) to 5 (very frequently). The Malay version questionnaire will be used.
Measured: Assessed at baseline, Week 1, Week 2, and Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start17 Oct 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- EP Plus Group Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeong Yeh Lee, MD, PhD, Principal investigator, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271538
- Sponsor's protocol ID
- EP-USM-122023-001
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-controlled Clinical Trial on the Efficacy of Skål Pro (Lactobacillus Plantarum 299 and Galacto-oligosaccharides) in Improving Severity of Symptoms, Stool Forms, Quality of Life and Psychological Dysfunction in Patients With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT06271538
- Acronym / sponsor ID
- EP-USM-122023-001
- Conditions
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Disease, Digestive System Disease, Pathologic Processes
- Keywords
- probiotic, Lactobacillus plantarum 299v, randomized controlled study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- EP Plus Group Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Irritable bowel syndrome (IBS) is a condition linked to disturbances in the gut-brain axis and dysbiosis. Although probiotic modulation of dysbiosis appears promising for IBS treatment, identifying the specific beneficial strains remains uncertain. Furthermore, even with an effective probiotic strain, variations in efficacy among populations are observed due to environmental heterogeneity, particularly dietary influences.
This study seeks to provide efficacy insights into Skal Pro powder 2g (containing Lactobacillus plantarum 299v 1x10^10 colony forming unit (CFU) and GOS), shedding light on the unique mechanisms of LP299V within the Malaysian population through a randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skal Pro | Experimental | Combination Product: Skal ProSkal Pro in the form of 2g sachet powder contains 10 billion CFU of freeze-dried Lactobacillus plantarum 299v (LP299V) and galactooligosaccharides (GOS). |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is an oral formulation of inert powder. Placebo and Skal Pro are identical in shape, size, colour, packaging and taste. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IBS diagnosed using the Rome IV criteria
- Age above 18 years old and any gender
- Any subtypes of IBS (diarrhea, constipation or mixed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skal ProOne sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10^10 CFU and GOS | Combination product | Skal Pro |
| PlaceboOne sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet | Other | Placebo |
Primary outcome
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
IBSSS questionnaire contains five questions that measures, on a 100-point visual analogue scale (VAS), the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life (QOL). All five components contribute to the scores equally, yielding a theoretically range of 0 - 500, with a higher score indicating worse condition. The Malay version questionnaire will be used.
6 secondary outcomes
Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary
Time frame: Assessed daily from baseline to Week 4.
Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary
Time frame: Assessed daily from baseline to Week 4.
Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
Change in Visceral Sensitivity Index
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
Assessment of psychological dysfunction suing Catastrophizing Questionnaire
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeong Yeh Lee, MD, PhD principal investigator
Hospital Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skal Pro in people with Irritable Bowel Syndrome and Gastrointestinal Diseases, run by EP Plus Group Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS) (time frame: Assessed at baseline, Week 1, Week 2, and Week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.