Irritable Bowel Syndrome Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 30, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - IBS diagnosed using the Rome IV criteria - Age above 18 years old and any gender - Any subtypes of IBS (diarrhea, constipation or mixed) Exclusion Criteria: - 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™) |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
EP Plus Group Sdn Bhd |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Assessed at baseline, Week 1, Week 2, and Week 4. | |
Secondary | 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 | Assessed daily from baseline to Week 4. | |
Secondary | Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary | Daily diary of number of bowel movements. | Assessed daily from baseline to Week 4. | |
Secondary | 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. | Assessed at baseline, Week 1, Week 2, and Week 4. | |
Secondary | 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. | Assessed at baseline, Week 1, Week 2, and Week 4. | |
Secondary | 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. | Assessed at baseline, Week 1, Week 2, and Week 4. | |
Secondary | 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. | Assessed at baseline, Week 1, Week 2, and Week 4. |
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