Research of Change of Microbial System Intestines and Efficacy for Probiotic Treatment of Persistent Diarrhea in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Changes in days of treatment for typical symptoms of persistent diarrhea
研究概览
简要总结
Persistent diarrhea is a common health problem worldwide, particularly in low-income countries. Approximately 3% to 20% of acute diarrhea episodes in children under 5 years of age become persistent diarrhea. Persistent diarrhea causes malnutrition, weight loss, and dehydration, as well as increasing treatment costs and the risk of mortality. One of the main causes of persistent diarrhea is the overgrowth and spread of bacteria, as well as viral infections that can disrupt the balance of microorganisms in the gut. Antibiotics are effective in treating bacterial infections that cause persistent diarrhea in children, but not against viral or parasitic infections. Overuse of antibiotics can lead to the growth of antibiotic-resistant bacteria, which poses a significant public health concern. Probiotics play a vital role in maintaining a healthy balance. Bacillus probiotic strains have an advantage over Lactobacillus probiotics as they can form spores that resist environmental stressors like heat, acid, and bile. This makes them more likely to survive the harsh conditions of the digestive tract and provide health benefits by reaching the intestines intact. Here, the investigators propose high-dose Bacillus spore probiotic supplementation as a potential solution for treating patients with persistent diarrhea.
The aim of the study is to assess the efficacy of two types of Bacillus probiotics which conclude LiveSpo CLAUSY (2 billion B. clausii) and LiveSpo DIA 30 (5 billion B. subtilis, B. clausii and B. coagulans) in supporting the treatment of children with persistent diarrhea.
Study Population: sample size is 150 patients and 30 healthy children. The study is carried out at Vietnam National Children's Hospital.
Description of Study Intervention: Totally 150 eligible patients are divided randomly into 3 groups (n = 50/group each): Patients in the Control group received the routine treatment and 2-3 times/day RO water while the patients in the probiotics group received 2-3 times/day LiveSpo DIA 30 or LiveSpo CLAUSY in addition to the same standard of care treatment. The standard treatment regimen is 5-9 days but can be extended further depending on the severity of the patient. Healthy children are grouped into the "Healthy" group solely for the purpose of comparing the microbiota between healthy children with those patients before and after treatment. Therefore, the Healthy group does not receive any intervention.
Study duration: 18 months
详细描述
Persistent diarrhea, which is defined as diarrhea that lasts for more than two weeks but less than four weeks, is a widespread health concern globally, particularly in low-income countries. It is a significant public health issue for children, especially in regions such as Asia, South America, and Africa. According to the World Health Organization (WHO), diarrhea is the second leading cause of morbidity and mortality in children after acute respiratory infections. Persistent diarrhea is a significant problem that defeats the nutritional status of children and increases treatment costs. The common pathogens associated with persistent diarrhea include:
Bacteria: Escherichia coli (E. coli), Campylobacter jejuni, Yersinia, Salmonella Enteritidis, Shigella spp., Clostridium difficile, Aeromonas.
Parasite: Giardia lamblia, Entamoeba histolytica, Cryptosporidium, Cyclospora, Microsporidia.
Viruses: norovirus, rotavirus, adenovirus. The intestinal microbiota serves as a protective barrier against pathogenic microorganisms and their toxins, playing a crucial role in the development and regulation of the immune system within the gut. Alterations in the gut microbiota have been observed in children with persistent diarrhea, highlighting its importance in maintaining gut health.
In terms of persistent diarrhea treatment, antibiotics are effective in treating bacterial infections that cause persistent diarrhea in children, but not against viral or parasitic infections. Overuse of antibiotics can lead to the growth of antibiotic-resistant bacteria, which poses a significant public health concern. Probiotics are live microorganisms that can provide health benefits to the host when consumed in sufficient amounts, playing a vital role in maintaining a healthy balance, which typically range from 1 to 10 billion per day, depending on the intended purpose of either prevention or supportive treatment. High-dose Lactobacillus rhamnosus GG probiotics, up to 40 billion per day, have been shown to be safe and effective in the treatment of antibiotic-associated diarrhea However, the quality of evidence is moderate to low. In comparison to Lactobacillus species, Bacillus species, such as B. subtilis, B. clausii, and B. coagulans, have the ability to form spores, which are resistant to environmental stressors such as heat, acid, and bile. This means that Bacillus probiotics are more likely to survive the harsh conditions of the digestive tract and reach the intestines intact, where they can provide health benefits. Bacillus probiotics have been found to be naturally resistant to certain antibiotics, which may make them a more effective option for individuals who are taking antibiotics or who have a history of antibiotic use. Thus, the investigators propose high-dose Bacillus spore probiotic supplementation as a potential solution for treating patients suffering from persistent diarrhea.
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)
盲法说明
LiveSpo DIA30, LiveSpo CLAUSY, and RO water are indistinguishable in terms of smell. However, due to the opaque plastic container of the LiveSpo product suspension, the color and turbidity of the suspension are unrecognizable to investigators, except for the Principal Investigator (PI), analyzer, nurses, patient's parents, and patients.
入排标准
- 年龄范围
- 2 Months 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are between 2 months and 24 months old
- •Have loose or unusual watery stools more than 3 times per day, lasting between 14 and 30 days
- •Parents of the pediatric patient agree to participate in the study, explain and sign the research consent form
排除标准
- •The patient had any systemic illness other than diarrhea on admission.
- •Patient has any systemic complications during treatment.
结局指标
主要结局
Changes in days of treatment for typical symptoms of persistent diarrhea
时间窗: Day 0 to Day 12
Changes in days of treatment for typical symptoms of persistent diarrhea, including: * the frequency of bowel movements per day (times/day) * the presence of mucus in stool (2 - lots of mucus, 1 - less mucus, 0 - no mucus) * the Bristol Stool Score ( 1 - Type 1, 2 - Type 2, 3 - Type 3, 4 - Type 4, 5 - Type 5A, 6 - Type 5B)
次要结局
- Changes in presence of white blood cells and red blood cells by stool microscopy(Day 3 and Day 5 compared to Day 0)
- Changes in Intestinal microbiota(Day 3 or/and Day 7 compared to Day 0)
- Change the stool pH values(Day 3 and Day 5 compared to Day 0)
- Changes in cytokines levels of blood samples(Day 5 compared to Day 0)
- Changes in IgA levels in both stool and blood samples(Day 5 compared to Day 0)
研究者
Ha Dang Thuy
Deputy Head of Gastrointestinal Department
National Children's Hospital, Vietnam
