Stunting and Bangladesh Environmental Enteric Dysfunction Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,575
- 试验地点
- 1
- 主要终点
- Change in Length for Age Z score
研究概览
简要总结
This is a community-based intervention study which will be undertaken at Mirpur, Dhaka, Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18 months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted children (length for age Z score, LAZ < -2), children who are at risk of stunting (length for age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for any organic diseases and application of inclusion/exclusion criteria, they will receive nutrition interventions. Participants eligible for study will be tested for potential bio markers of environmental enteropathy (stool, urine and serum) once before and once after the nutritional intervention. Participants who will fail to respond to nutritional therapy (measured by anthropometric assessment) will become candidates for upper gastrointestinal endoscopy with biopsy. The study will include duodenal biopsies from a control group of children from University of Virginia Hospital in Charlottesville, Virginia who will undergo upper GI endoscopy as part of their clinical care as per the standard clinical protocol followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka.
详细描述
Study design This will be a community-based intervention study. Survey, screening, enrollment of subjects will be done in Mirpur in Dhaka city.
Subjects Participants will be recruited from two age groups: a child cohort (age 12 to 18 months) and an adult cohort (age 18 to 45 years). The child cohort will consist of two groups of children- stunted children (LAZ score < -2) and children who are at risk of stunting (LAZ <-1 to -2). A group of malnourished adults (BMI <18.5) will also be enrolled from the parents of children and by a cross sectional survey from Mirpur area of Dhaka city.
Sample size:
Participants will be collected and recruited in a cross sectional manner. Based on a sample size calculation with 10% precision and 95% confidence interval, a minimum of 35 stunted children, 35 at risk of stunting children and 35 adults will be recruited. So, the final sample size for endoscopy is 105 subjects (35+35+35). As endoscopy is an invasive procedure, it was assumed that only one-third of those who would fail to respond after nutrition intervention would give consent for endoscopy. So, basic sample size was increased three times for a minimum of 105 (35 x 3) stunted children (LAZ <-2), 105 (35 x 3) children at risk of stunting (LAZ <-1 to 2) and 105 (35 X 3) malnourished adults (BMI < 18.5) who would fail to thrive. To achieve that 525 stunted children, 525 children at risk of stunting and 525 malnourished adults for nutrition interventions will be recruited as it was assumed that ~20% of each group will fail to respond despite the nutritional intervention. For that order of recruitment surveying at least 3977 (1312+2665) children 12-18 months old and 2100 adults based on the current prevalence of malnutrition in the two age groups is required. For adult control group, same number (35) of adult controls will be recruited from Dhaka Medical College and international centre for diarrhoeal disease research,Bangladesh staff clinic by convenient sampling method
Description of field site:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for stunted children: All of the following criteria must be met for a subject to be eligible to participate in the study-
- •Parent(s) willing to sign consent form
- •Child age 12-18 months
- •LAZ < -2
- •Parent(s) willing to bring child to the study site every day for 3 months for nutritional therapy
- •Parents willing to have child undergo laboratory investigations and upper GI endoscopy and biopsy if the child fails to respond to nutritional therapy
- •Inclusion criteria for children who are at risk of stunting: All of the following criteria must be met for a subject to be eligible to participate in the study -
- •Parent(s) willing to sign consent form
- •Child age 12-18 months
- •LAZ between <-1 to -2
- •Parent(s) willing to bring child to the study site every day for 2 months for nutritional therapy
- •Parents willing to have child undergo endoscopy and biopsy if the child fails to respond to nutritional therapy
- •Inclusion criteria for malnourished adults: All of the following criteria must be met for a subject to be eligible to participate in the study -
- •Willing to sign consent form
- •Age 18-45 years
- •BMI < 18.5
- •Willing to visit the study site every day for 2 months for nutritional therapy
- •Willing to undergo endoscopy and biopsy if he/she fails to respond to nutritional therapy
- •Selection criteria for adult controls:
- •An equal number of age and sex matched adult controls will be enrolled form the subjects with functional dyspepsia (FD) with apparently normal health (normal BMI) and absence of organic diseases. FD subjects will be identified from the Gastroenterology outpatient department of Dhaka Medical College Hospital and international centre for diarrhoeal disease research, Bangladesh staff clinic who will undergo upper GI endoscopy for evaluation of dyspepsia and have normal endoscopic findings. Dyspepsia will be defined by pre-defined criteria (Rome III criteria) by a structured questionnaire which has been translated and validated in Bengali.
排除标准
- •Exclusion criteria for stunted children: Meeting any of the following criteria will exclude a subject from study participation -
- •Severe acute malnutrition (SAM), severe anemia (<8 g/dl), tuberculosis, other chronic diseases or any congenital disorder or deformity
- •Diarrhoea: Ongoing episode of diarrhoea, history of persistent diarrhoea in the past month or history of acute diarrhoea in the past 7 days
- •Known allergy to eggs or milk or milk intolerance
- •Exclusion criteria for children who are at risk of stunting: Meeting any of the following criteria will exclude a subject from study participation -
- •Severe acute malnutrition (SAM), severe anemia (<8 g/dl), tuberculosis, other chronic diseases or any congenital disorder or deformity
- •Diarrhoea: Ongoing episode of diarrhoea, history of persistent diarrhoea in the past month or history of acute diarrhoea in the past 7 days
- •Known allergy to eggs or milk or milk intolerance
- •Exclusion criteria for malnourished adults: Meeting any of the following criterions will exclude a subject from study participation-
- •Severe anemia (<8 g/dl), tuberculosis and other chronic diseases including diabetes mellitus or any congenital disorder or deformity
- •Pregnant women, lactating women, drug abusers, known psychiatric disorders
- •High clinical suspicion of cancer or other chronic or acute diseases that may cause malnutrition. Adult participants who fulfilled the inclusion criteria and not excluded through history and clinical examination based exclusion criteria will undergo screening tests for confirmation.
研究组 & 干预措施
Malnourished participants
After screening the participants for any organic diseases and application of inclusion/exclusion criteria, stunted children, children who are at risk of stunting and malnourished adult cases will receive one egg, 150 ml of milk 6 days a week for 3, 2 and 2 months respectively. Along with that participants will also get Anti-helminthic treatment (Albendazole/Pyrantel Pamoate) and nutritional counselling. Children will get one sachet of multiple micro-nutrient sprinkles per day to be administered at home with the mid-day meal for two months.
干预措施: Egg (Dietary Supplement)
Malnourished participants
After screening the participants for any organic diseases and application of inclusion/exclusion criteria, stunted children, children who are at risk of stunting and malnourished adult cases will receive one egg, 150 ml of milk 6 days a week for 3, 2 and 2 months respectively. Along with that participants will also get Anti-helminthic treatment (Albendazole/Pyrantel Pamoate) and nutritional counselling. Children will get one sachet of multiple micro-nutrient sprinkles per day to be administered at home with the mid-day meal for two months.
干预措施: Milk (Dietary Supplement)
Malnourished participants
After screening the participants for any organic diseases and application of inclusion/exclusion criteria, stunted children, children who are at risk of stunting and malnourished adult cases will receive one egg, 150 ml of milk 6 days a week for 3, 2 and 2 months respectively. Along with that participants will also get Anti-helminthic treatment (Albendazole/Pyrantel Pamoate) and nutritional counselling. Children will get one sachet of multiple micro-nutrient sprinkles per day to be administered at home with the mid-day meal for two months.
干预措施: Albendazole/Pyrantel Pamoate (Drug)
Malnourished participants
After screening the participants for any organic diseases and application of inclusion/exclusion criteria, stunted children, children who are at risk of stunting and malnourished adult cases will receive one egg, 150 ml of milk 6 days a week for 3, 2 and 2 months respectively. Along with that participants will also get Anti-helminthic treatment (Albendazole/Pyrantel Pamoate) and nutritional counselling. Children will get one sachet of multiple micro-nutrient sprinkles per day to be administered at home with the mid-day meal for two months.
干预措施: Nutritional counselling (Behavioral)
Malnourished participants
After screening the participants for any organic diseases and application of inclusion/exclusion criteria, stunted children, children who are at risk of stunting and malnourished adult cases will receive one egg, 150 ml of milk 6 days a week for 3, 2 and 2 months respectively. Along with that participants will also get Anti-helminthic treatment (Albendazole/Pyrantel Pamoate) and nutritional counselling. Children will get one sachet of multiple micro-nutrient sprinkles per day to be administered at home with the mid-day meal for two months.
干预措施: Micronutrient sprinkles (Dietary Supplement)
结局指标
主要结局
Change in Length for Age Z score
时间窗: baseline and 3 months
For stunted child participants, length and age data will be collected before and after the intervention period (3 months) and changes in length for age Z score will be measured.For at risk of stunting child participants, length and age data will be collected before and after the intervention period (2 months) and changes in length for age Z score will be measured.
Change in Body Mass Index
时间窗: baseline and 2 months
For malnourished adult participants, height and and weight data will be collected before and after the intervention period (2 months) and changes in Body Mass Index will be measured.
次要结局
- Change in stool Regeneration gene 1 Beta (Reg 1B) biomarker level(baseline and 3 months)
- Change in stool neopterin level(baseline and 3 months)
- Change in stool myeloperoxidase level(baseline and 3 months)
- Change in stool Alpha-1-antitrypsin level(baseline and 3 months)
- Change in stool Calprotectin level(baseline and 3 months)
- Change in stool TaqMan Array Card (TAC) result(baseline and 3 months)
- Change in gut microbiota maturity status(baseline and 3 months)
- Change in lactulose and rhamnose permeability test(baseline and 3 months)
- Change in blood C-reactive protein level(baseline and 3 months)
- Change in blood Alpha-1-acid glycoprotein level(baseline and 3 months)
- Change in blood sCD14 level(baseline and 3 months)
- Change in blood kynurenine Tryptophan ratio(baseline and 3 months)
- Change in blood Glucagon-like peptide-2 level(baseline and 3 months)
- Change in blood ferritin level(baseline and 3 months)
- Change in blood zinc level(baseline and 3 months)
- Change in blood pepsinogen I & II level(baseline and 3 months)
- Change in blood Low density lipoprotein related receptor 1 (LRP1) level(baseline and 3 months)
- Change in blood metabolomic profile(baseline and 3 months)
- Change in small intestinal bacterial overgrowth (SIBO) status(baseline and 3 months)