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临床试验/NCT04698759
NCT04698759
已完成
不适用

Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status

Bina Nusantara University1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2020年1月9日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Bina Nusantara University
入组人数
131
试验地点
1
主要终点
IL -10

概览

简要总结

  1. Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
  2. Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.
  3. Population and Research Sample The population is children between three and five years old in the village of stunting locus.

The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.

详细描述

The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.

Stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.

The nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore

  1. weight for age (referred as Z-score
  2. and weight for height (referred as Z-score
  3. .A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (<-3 SD); 'stunted' (-3 SD to < -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (<-3 SD); 'wasted' (-3 SD to < -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (> +2 SD to +3 SD); 'obese' (> +3 SD)

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children age : 3 - 5 years old (36-60 months)
  • Live in the research area
  • Apparently healthy children, after examination by a physician
  • Involved in a research study (informed consent signed by parent or guardian)

排除标准

  • Children age \< 36 month and \> 60 month
  • Live outside research area
  • Unhealthy, after examination by a physician

结局指标

主要结局

IL -10

时间窗: 1 week analysis

unit pg/ml from serum

TNF alfa

时间窗: 1 week analysis

unit pg/mL from serum

TGF beta

时间窗: 1 week analysis

Unit : pg/mL from serum

sIgA

时间窗: 1 week analysis

Unit : ul/ml from feses extract

LBP

时间窗: 1 week analysis

Unit ul/ml from serum

次要结局

  • Short Chain Fatty Acid(1 months)

研究者

发起方
Bina Nusantara University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingrid S Surono

Principal Investigator

Bina Nusantara University

研究点 (1)

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