Tolerability and Acceptability of Fibersol-2 (Resistant Maltodextrin) in Healthy and Diarrheal Children Followed by a Randomized Clinical Trial to Evaluate the Efficacy of Fibersol-2 in Diarrheal Children 1-3 Years Old
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Duration of diarrhea
研究概览
简要总结
Dietary fiber, a non-digestible carbohydrate, used in decades for the beneficial effect on health with physiological importance because such compounds have low energy values. These indigestible carbohydrates generally reach the large intestine undigested and unabsorbed, they are often used in many functional and/or low-calorie food and beverages. Researchers have stated that dietary fiber especially digestive-resistant maltodextrin has innumerable beneficial effects on human health, such as improving intestinal regularity by increasing fecal bulk, stimulating peristalsis and shortening gastrointestinal transit time. Resistant maltodextrin (Fibersol-2) is a low viscosity, water-soluble, indigestible dextrin produced by the treatment of corn starch with acid, enzymes, and heat. Dietary fiber, a non-digestible carbohydrate, has been used in decades for the beneficial effect of health with physiological importance. In developing countries most of the diarrhea episodes occur during the first two years of life and till date antibiotics have been found to have no role in over seventy five percent of young childhood diarrhea. Toddler's diarrhea which affects children aged 6 to 60 months is known as chronic nonspecific diarrhea of childhood. The stool is frequently watery or loose and may have food particles in it. Despite the diarrhea, the child continues to grow and gain weight, remains active and has a normal appetite. The beneficial effects of resistant maltodextrin are well known in developed countries; however, data are lacking in developing countries. It has become imperative to know its safety, tolerability and acceptability in small children with or without diarrhea in developing countries such as in Bangladesh.
详细描述
To conduct an exploratory study to understand the digestive tolerability of resistant maltodextrin (Fibersol-2) in young healthy and diarrhea children aged 1-3 years for 30 children at home and 30 children at hospital in phase 1. Additionally, propose to conduct a placebo-controlled, randomized, double blind clinical trial to examine whether Fibersol-2 with water can reduce the duration of diarrhea and stool output in children of 1-3 years old in the tertiary level hospital. If the child vomits out within 10 minutes of oral intake, we will give him again similar amount of fibersol-2 for consumption after an hour of rejection; if the child vomits again within 10 minutes of next intake, we will stop giving him fibersol-2 anymore. Also assess the digestive tolerability of the study children. In addition to gathering information from hospital, field research staff will visit the households of study children to collect information about their health status by administering field tested questionnaire.
Study staff members will follow-up the study participants round the clock (24 hrs) during their hospital stay. To ensure the patient care they maintain a roster duty with staff members consisting 2 Project Research Physicians, 4 Study Nurse, 2 Field Research Assistants and 4 Field Organizer. Project physician will be responsible for consenting as well as all clinical assessment including the assessment of the diarrheal patients and provide treatment, besides these they will be given treatment for other illness if needed, our study nurses are responsible for recording vital signs and will feed the Fibersol-2 to the study participants in front of their legal guardians at hospital and community level with appropriate dose and time. They will also be closely monitoring the participants after oral intake of fibersol-2; if any adverse event is observed they will call the study physician immediately. Field Research assistant and Field Organizer will be screening the community control as well as will record other socio-demographic information and anthropometry as required. Also assist the study nurse in monitoring the study participants at household level.
Eligibility criteria for the clinical efficacy trial
Inclusion criteria:
(i) Children with acute watery diarrhea, 3 or more watery stool in any 24-hour period of <7 days duration with none or some dehydration (ii) Aged between 1-3 years, and (iii) Received written consent from parents
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)
盲法说明
A placebo-controlled, randomized; double-blind 2 arm trial to assess the efficacy of fibersol-2 in children with acute watery diarrhea.
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with acute watery diarrhea, 3 or more watery stool in any 24-hour period of <7 days duration with none or some dehydration
- •Aged between 1-3 years, and
- •Received written consent from parents
排除标准
- •Children with bloody diarrhea, severe diseases (severe sepsis, meningitis, severe pneumonia with respiratory distress requiring intensive care and ancillary support such as oxygen inhalation, orophryngeal suction etc.
- •Child in a situation and could interfere with the optimal participation to the study or constitute a particular risk of non-compliance
- •Currently participating in another clinical trial, and
- •Parents refused to give written consent.
结局指标
主要结局
Duration of diarrhea
时间窗: 72 hours
Main outcome measure is duration of diarrhea
Stool consistency.
时间窗: 24 hrs
Stool consistency measured by regular observation
次要结局
未报告次要终点