A Phase 4 interventional study of Skal Pro and Placebo in Irritable Bowel Syndrome, Gastrointestinal Diseases and Colonic Diseases, Functional, sponsored by EP Plus Group Sdn Bhd. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by EP Plus Group Sdn Bhd · Phase 4, Interventional, and Treatment
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.
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).
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →This is the only study on the registry with EP Plus Group Sdn Bhd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Skal Pro in the form of 2g sachet powder contains 10 billion CFU of freeze-dried Lactobacillus plantarum 299v (LP299V) and galactooligosaccharides (GOS).
Combination Product: Skal Pro
Placebo is an oral formulation of inert powder. Placebo and Skal Pro are identical in shape, size, colour, packaging and taste.
Other: Placebo
One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10\^10 CFU and GOS
One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet
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.
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Apr 2026, 17 months.
Of 24 phase 4 interventional studies under Irritable Bowel Syndrome, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 29. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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