Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 主要终点
- Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
研究概览
简要总结
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
详细描述
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.
Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.
Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.
Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.
Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS-D diagnosis using the Rome III questionnaire
- •IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400
- •Bristol Stool Form Scale score exceeding two (> 2) but less than seven (< 7)
- •Stable diet
- •Mental and legal ability to sign informed consent
排除标准
- •Diagnosis of Inflammatory Bowel Disease (IBD)
- •Chronic use of systemic steroids
- •Diagnosis of autoimmune Diseases or Disorders
- •Invasive abdominal surgery
- •Use of antibiotics prior to screening
- •Allergy to active substance or any other ingredient in LACTEOL® 340 mg
- •Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance
- •Diagnosis of exocrine pancreatic insufficiency
- •Use of any experimental drug within the 30 days prior to screening
研究组 & 干预措施
LACTEOL® 340 mg
干预措施: LACTEOL® 340 mg (Drug)
PLACEBO
干预措施: PLACEBO (Drug)
结局指标
主要结局
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
时间窗: Weekly Assessment (every 7 days)
Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"
次要结局
- Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)(Weekly Assessment (every 7 days))
- Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale(Daily assessment)
- Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score(Weekly assessment (every 7 days))
- Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase(At Screening and End of Double-Blind Treatment Phase)
- Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score(Weekly assessment (every 7 days))
- Stool Characteristics During the Open-Label Treatment Phase Using the BSFS(Daily assessment)
- Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study(8 weeks)