Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms and Improve Quality of Life in Patients Diagnosed With Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Bristol scale
研究概览
简要总结
Irritable bowel syndrome (IBS) is a recurrent, functional disorder characterized by abdominal pain and discomfort, changes in bowel habits and gastrointestinal symptoms such as distension and sensation of abdominal inflammation, incomplete evacuation, urgency and tenesmus. In addition to gastrointestinal symptoms, patients with IBS often experience a wide range of other problems, such as non-abdominal pain, psychological symptoms, poor quality of life, and difficulties in carrying out activities of daily living. Studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of IBS. Our objective is to develop a probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) is safe and effective in reducing symptoms caused by IBS, as well as improving quality of life. In the present study, 114 volunteers of both genders will be included, randomly distributed into two groups: Test group (n=57): Volunteers supplemented with the probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus- Final concentration: 1 x 1010 CFU/day). Placebo Group (n=57): Volunteers supplemented with placebo. The study will last 90 days and will have 3 visits to apply the proposed questionnaires.
详细描述
Irritable bowel syndrome (IBS) is a recurrent, functional disorder characterized by abdominal pain and discomfort, changes in bowel habits and gastrointestinal symptoms such as distension and sensation of abdominal inflammation, incomplete evacuation, urgency and tenesmus. This disorder affects men and women of all age groups, with a worldwide prevalence of 10% to 20%. In addition to gastrointestinal symptoms, patients with IBS often experience a wide range of other problems, such as non-abdominal pain, psychological symptoms, poor quality of life, and difficulties in carrying out activities of daily living. Treatment is usually symptomatic and associated with changes in lifestyle and diet, drug and psychological treatments and the use of probiotics. Studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of IBS. Furthermore, certain compositions of specific probiotics are found to have benefits, especially in quality of life, bloating and abdominal pain.
The hypothesis is that the use of a probiotic blend can reduce gastrointestinal symptoms and improve quality of life through its immunomodulatory and intestinal regulation mechanisms in patients with IBS
aim: To develop a safe and effective probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) to reduce the symptoms caused by IBS.
METHODS
Randomized, double-blind, placebo-controlled study to evaluate the effectiveness of a probiotic blend (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) in improving symptoms caused by Bowel Syndrome Irritable (IBS). Study will be conducted with patients diagnosed with IBS by the gastroenterologist participating in the study, being an adult audience (18 - 65 years old). In the present study, 114 volunteers of both sexes will be included, randomly distributed into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provision of Free and Informed Consent in writing, signed and dated;
- •Age according to the indicated population;
- •Patients diagnosed with IBS by a specialist.
排除标准
- •Individuals with a history of daily consumption of probiotics, fermented milk and / or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product;
- •Individuals who have unbalanced blood pressure; hx of heart disease, including valvulopathies or any implantable device; individuals on immunosuppressive therapy or any health condition causing immunosuppression; individuals with active, uncontrolled bowel disease such as Crohn's disease or ulcerative colitis;
- •Women who are pregnant at the time of enrollment or who plan to become pregnant during the study;
- •Individuals with concomitant participation in another clinical trial;
- •History of autoimmune disease.
结局指标
主要结局
Bristol scale
时间窗: Three times (0, 45 and 90 days after inclusion)
The Bristol Stool Form Scale is used for describing feces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea. People with irritable bowel syndrome (IBS) typically report that they suffer with abdominal cramps and constipation. In some patients, chronic constipation is interspersed with brief episodes of diarrhoea; while a minority of patients with IBS have only diarrhoea.
次要结局
- Change of quality of life (SF-36 scale)(Three times (0, 45 and 90 days after inclusion))
- Change of mental health - depression(Three times (0, 45 and 90 days after inclusion))
- Change of mental health - anxiety(Three times (0, 45 and 90 days after inclusion))
- Gastrointestinal Symptom Rating Scale (GSRS)(Three times (0, 45 and 90 days after inclusion))
研究者
Monique Michels
Principal Investigator
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude