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.
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
Parallel
Skal Pro
Combination productOne sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10\^10 CFU and GOS
Placebo
Other interventionOne 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.
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
Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary
Daily diary of number of bowel movements.
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.
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.
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