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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS diagnosed using the Rome IV criteria
- •Age above 18 years old and any gender
- •Any subtypes of IBS (diarrhea, constipation or mixed)
排除标准
- •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™)
研究组 & 干预措施
Placebo
Placebo is an oral formulation of inert powder. Placebo and Skal Pro are identical in shape, size, colour, packaging and taste.
干预措施: Placebo (Other)
Skal Pro
Skal Pro in the form of 2g sachet powder contains 10 billion CFU of freeze-dried Lactobacillus plantarum 299v (LP299V) and galactooligosaccharides (GOS).
干预措施: Skal Pro (Combination Product)
结局指标
主要结局
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
时间窗: 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.
次要结局
- Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)(Assessed at baseline, Week 1, Week 2, and Week 4.)
- Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary(Assessed daily from baseline to Week 4.)
- Change in Visceral Sensitivity Index(Assessed at baseline, Week 1, Week 2, and Week 4.)
- Assessment of psychological dysfunction suing Catastrophizing Questionnaire(Assessed at baseline, Week 1, Week 2, and Week 4.)
- Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary(Assessed daily from baseline to Week 4.)
- Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire(Assessed at baseline, Week 1, Week 2, and Week 4.)