Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo
研究概览
简要总结
- To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
- To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre
详细描述
Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.
Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.
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)
盲法说明
Participants divided into two groups by randomization software, consisting of 200 in each group.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed case of IBS using Rome III criteria
- •Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer
- •Age 18-55 years
- •No probiotics used in prior 3 months.
- •Agreed not to start any other drug unless clinically indicated.
- •No antibiotics in previous 2 months of enrolment.
排除标准
- •Age<18 or >55 years
- •Previous treatment with probiotics within last 3 months
- •Pregnant or lactating females
- •Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism)
- •Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc
- •Any previous gastrointestinal surgery
研究组 & 干预措施
To assess the effect of multistrain probiotics on abdominal
To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
干预措施: Probiotic Formula Capsule (Drug)
To assess the efficacy of a multistrain probiotic supplement
To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre
干预措施: Probiotic Formula Capsule (Drug)
结局指标
主要结局
The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo
时间窗: 1 year.
The change in severity and frequency of abdominal pain as measured by IBS-Symptom Severity Scores during treatment with a multi-strain probiotic or placebo, and compared with baseline.
次要结局
未报告次要终点
研究者
S M khosruzzaman
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh