NCT Number: NCT06271538
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Kubang Kerian, Kelantan, 16150, Malaysia
Location status: Recruiting
Thai Hau Koo, MD
SUB_INVESTIGATOR
Yeong Yeh Lee, MD, PhD
CONTACT
+6097676846 ext. 6845
Yeong Yeh Lee, MD, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Assessed daily from baseline to Week 4.
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.
Daily diary of number of bowel movements.
Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
EP Plus Group Sdn Bhd
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01130272
Colonic Diseases, Colonic Diseases, Functional
Anniston, Alabama, United States
View Trial DetailsNCT01553747
Colonic Diseases, Colonic Diseases, Functional
Birmingham, Alabama, United States
View Trial DetailsNCT05340400
Colonic Diseases, Colonic Diseases, Functional
Aleppo, Syria
View Trial DetailsNCT02551029
Abdominal Pain, Colonic Diseases
Maastricht, Netherlands
View Trial Details