Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation: Molecular Profile of Fecal Microbiome With NGS Method
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Short Chain Fatty Acid (SCFA) titer
研究概览
简要总结
In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a Biomarker improvement symptom and quality of life women with functional constipation after supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from indigenous probiotics from Dadih, West Sumatra) for 21 days
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
- •Having the symptoms and signs of functional constipation refer to ROME IV
- •Able to communicate well
- •Able to consume 1 bottle of fermented milk each day for three weeks
- •Not using antibiotic no later than one week before supplementation
排除标准
- •Diagnosed with functional bowel disorder
- •Using anesthesia at least 4 weeks before treatment
- •Having a serious pathological disorder (carcinoma)
- •During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
- •Having severe heart disease
- •Taking chronic medications such as antidepressants or analgesics
研究组 & 干预措施
Lactobacillus plantarum
1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10^8 CFU will be given daily for three weeks.
干预措施: Lactobacillus plantarum (Drug)
Placebo
1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Short Chain Fatty Acid (SCFA) titer
时间窗: Three weeks after intervention
Short Chain Fatty Acid (SCFA) titer that will be analyzed by Gas chromatography-mass spectrometry (GCMS) consists of three metabolites: * Butyrate will be shown in mM unit measure, higher value represents better outcome * Acetate will be shown in mM unit measure, higher value represents better outcome * Proprionate will be shown in mM unit measure, higher value represents better outcome
Functional constipation symptom improvement (1)
时间窗: Three weeks after intervention
Functional constipation symptom improvement (1) will be measured by improvement of PAC Sym questionnaire score. PAC Sym (Patient Assessment of Constipation Symptoms) has a minimum score of 0, maximum score 48, lower value represents better outcome
Molecular Profile of Fecal Microbiome
时间窗: Three weeks after intervention
Microbiome profile from faecal samples will be analyzed with NGS (Next Gen Sequencing) method. The result will be analyzed with MiSEq Reporter software (MSR) and will be presented in nM unit measure.
Functional constipation symptom improvement (2)
时间窗: Three weeks after intervention
Functional constipation symptom improvement (2) will be measured by improvement of PAC QoL questionnaire score. PAC QoL (Patient Assessment of Constipation Quality of Life) has a minimum score of -20, maximum score 92, lower value represents better outcome
次要结局
未报告次要终点
研究者
Murdani Abdullah
Clinical Professor
Fakultas Kedokteran Universitas Indonesia