The Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Improvement of symptoms of constipation
研究概览
简要总结
Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in consumption of products containing fiber, intake of drugs or laxatives, decreased intestinal motility and physical inactivity. The objective was to evaluate the effect of consumption of dairy products with probiotics on constipation. Randomized double-blind clinical trial in the city of Bom Retiro do Sul / RS, Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack.
详细描述
Randomized double blind clinical trial conducted at the health center of the city of Bom Retiro do Sul / RS, Brazil, from December 2014 to March 2015. The study began after approval by the Ethics Committee of the Research Center University Univates (COEP), Lajeado. Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack. The milk drink was provided in the homes of participants and the health center of the city of Bom Retiro do Sul once a week. At the beginning of treatment and at the end of treatment that will last 60 days, will be delivered to Bristol Scale and the criteria of Rome III, so as to verify the improvement or not of constipation. Patients who agree to participate in the study signed a consent form IC. Will be the orientation for the volunteers not to consume yogurt and other cultured milks with probiotics, will also be oriented to maintain the same diet and lifestyle when they were constipated, thus, check for improvement in constipation with the use of probiotics .
Inclusion criteria: Having a diagnosis of constipation; Be aged between 20 and 50 years; being female.
Data collection brings no risk or damage to entrant, but can cause discomfort and embarrassment to meet the criteria of Rome III and Bristol Scale and the time that will have to spend 10 to 15 minutes. Such issues will be mitigated by the fact that the interview be individualized and the participant have at their disposal a private room to answer the questionnaires, only with the presence of the academic.
Participants will not obtain any financial benefit, only the benefits of milk drink with probiotics and how much consumption adds to your health. It is also important to note that participation in the study will not result in expenses.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having a diagnosis of constipation;
- •Have aged between 20 and 50 years;
- •Being female.
排除标准
- •Patients with diabetes;
- •Patients pregnant and lactating women;
- •Patients with diarrhea, with previous gastrointestinal disorders;
- •Current or recent consumption of antibiotics, anti-inflammatory drugs, laxatives or other drugs;
- •Patients with diseases that alter bowel habits, such as food allergies and intolerances, ulcerative colitis, chron's disease and irritable bowel syndrome.
- •Patients who have lactose intolerance or dislike of milk drink.
结局指标
主要结局
Improvement of symptoms of constipation
时间窗: 60 days
Improvement of symptoms of constipation by ROME III criteria and Bristol scale.
次要结局
- Increased number of bowel movements(60 days)
研究者
Thaís Rodrigues Moreira
Nutrition Course Professor
Centro Universitário Univates
