The Efficacy Evaluation of Bifidobacterium Animalis Subsp. Lactis TCI604 Probiotic on Intestinal Function Improvement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of stool form
研究概览
简要总结
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female subjects aged 18 to 65 who are willing to sign the informed consent form;
- •Diagnosed with functional constipation as assessed by a physician;
- •Non-pregnant females who agree to use physical contraceptive methods during the study period (e.g., condoms, intrauterine devices);
- •No history of organ transplantation, epilepsy or seizures, liver or kidney disease, malignancy, psychiatric disorders, alcohol or drug abuse, or other major organic diseases (as determined by medical history).
排除标准
- •Use of probiotics, gastrointestinal health supplements, medications, or antibiotics within 30 days prior to the study;
- •Presence of chronic gastrointestinal diseases (e.g., irritable bowel syndrome [IBS], inflammatory bowel disease [IBD], Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcers, colorectal cancer, short bowel syndrome, ulcerative colitis);
- •History of gastrointestinal or major surgery;
- •Lactose intolerance;
- •Chronic diarrhea;
- •Pregnant or breastfeeding women;
- •Known allergy to any components of the study product.
研究组 & 干预措施
Placebo
Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks
干预措施: Placebo (Dietary Supplement)
TCI604 probiotics
Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks
干预措施: TCI604 probiotics (Dietary Supplement)
结局指标
主要结局
The change of stool form
时间窗: Week 0 (Baseline), Week 2, Week 4
The stool type will be assessed by The Bristol Stool Form Scale (BSFS). The BSFS is a scale that classifies stools, ranging from the hardest (type 1) to the softest (type 7).
The change of bowel movement and gastrointestinal discomforts
时间窗: Week 0 (Baseline), Week 2, Week 4
The Gastrointestinal Symptom Rating Scale (GSRS) will be utilized to assess the bowel movement and gastrointestinal discomforts. The GSRS consists of 15 items, each rated on a 7-point Likert scale. A higher score indicates more severe and frequent symptoms.The total GSRS score is calculated by taking the average score of the five symptom categories- Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation- summing them up, and then dividing the total by five to obtain the overall mean score.
次要结局
- The change of serum Interleukin-17A level(Week 0 (Baseline), Week 4)
- The change of intestinal microbiota(Week 0 (Baseline), Week 4)
- The change of serum Interleukin-6 level(Week 0 (Baseline), Week 4)
- The change of serum Interleukin-8 level(Week 0 (Baseline), Week 4)
- The change of serum Interleukin-10 level(Week 0 (Baseline), Week 4)
- The change of blood High-sensitivity C-Reactive Protein level(Week 0 (Baseline), Week 4)
- The change of serum Lipopolysaccharide binding protein level(Week 0 (Baseline), Week 4)
- The change of serum neopterin level(Week 0 (Baseline), Week 4)
- The change of intestinal fecal loading(Week 0 (Baseline), Week 4)