Efficacy of Using Bifidobacterium Lactis CCT 7858 in Improving Gastrointestinal Symptoms in Adults Using Antibiotics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Decreased diarrhea
研究概览
简要总结
To evaluate the effectiveness of the probiotic Bifidobacterium lactis CCT 7858 in preventing and / or improving gastrointestinal symptoms in adults using antibiotics. For this, a randomized, double-blind, placebo-controlled clinical trial will be carried out. The sample will be composed of adults who will be recruited in a hospital, who have been hospitalized and receive a prescription for antibiotics. The individuals will be separated into two groups: intervention and placebo. 104 patients will be included, 52 for each group. Inclusion criteria:
adults of both sexes and aged between 18 and 65 years, who have been recruited within 24 hours after starting antibiotic treatment, the prescribed treatment should be with antibiotics for a minimum of 9 days and a maximum of 14 days. The informed consent must be signed before starting the study.
详细描述
Two groups (placebo and intervention) will receive supplementation, the Placebo group will receive maltodextrin and Intervention group will receive probiotic B. lactis, that should be consumed for a period of 10 to 14 days depending on the duration of administration of the antibiotic (should be consumed until 7 day after the last antibiotic).
As a way of ensuring an equal distribution of the number of participants in the study groups and ensuring that the groups are similar, a randomization by blocks will be carried out and stratified by sex and age. The program that will be used to generate random numbers is the Research Randomizer Form v4.0. The packaging of both supplements will be identical except for the color, which will distinguish maltodextrin from probiotic.
Supplements will be delivered by a research collaborator as a way to guarantee blinding.
The probiotic to be supplied will be Bifidobacterium lactis CCT 7858 (GABBIA® Biotechnology and Development, Santa Catarina, Brazil). The probiotic will be offered in capsule and in the concentration of 9x10 10 UFC.
The groups will be evaluated in two moments: baseline and final.
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
- 否
入选标准
- •Adults of both sexes;
- •Aged between 18 and 65 years;
- •24 hours after starting antibiotic treatment;
- •Antibiotics tretament for a minimum of 3 days and a maximum of 14 days;
- •Informed consent must be signed before starting the study.
排除标准
- •blood pressure is outside the normal range (systolic blood pressure> 140, systolic blood pressure <90, diastolic> 90);
- •history of heart disease, including heart valve disease or heart surgery, any implantable device;
- •continuous or recent use of antibiotic therapy in the 30 days prior to the first administration of the study supplement;
- •ostomates or users of parenteral nutrition;
- •immunosuppressive therapy or any health condition that causes immunosuppression (including hematology malignancies, AIDS);
- •Crohn's disease or ulcerative colitis;
- •previous infection with Clostridium difficile documented less than 3 months before the start of the study;
- •history of daily consumption of probiotics, fermented milk;
- •individuals known to have demonstrated a previous reaction, including anaphylaxis, to any substance in the study product composition;
- •individuals with active diarrhea (3 or more liquid stools per 24 hour period);
- •pregnant women at the time of recruitment or planning to become pregnant during the study;
- •Individuals with concomitant participation in another clinical trial.
结局指标
主要结局
Decreased diarrhea
时间窗: 10 - 14 days
Decreased diarrhea through bristol scale. The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Categories: 1 - 7
次要结局
- Improve in Quality of life(10-14 days)
- Improve of gastrointestinal symptoms(10 - 14 days)
研究者
Felipe Dal Pizzol
Clinical Professor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude