Efficacy of Striatin on Weight Gain, Improvement of Acute Phase Inflammatory Marker, and the Change of Firmicutes Bacteroidetes (F/B), SCFA, BDNF Proteins in Malnourished Children: A Preliminary Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Absolute and relative weight increase
研究概览
简要总结
This is a double-blind randomized-controlled clinical trial to identify the effect of Striatin (snakehead fish extract) supplementation in increasing body weight, improving acute inflammatory markers and microbiota profiles in children with severe acute malnutrition (SAM) treating with standard nutritional therapy.
The main questions to answer are:
Does Striatin supplementation effective in increasing body weight and improving acute inflammatory markers in SAM children? What are the adverse events of Striatin supplementation in SAM children?
Researchers will compare Striatin supplementation and placebo (a look-alike substance that contains no drug) to identify the increase of body weight, improvement of acute inflammatory markers and microbiota profiles.
详细描述
- Children aged 12-59 months diagnosed with SAM based on weight-for-height Z score (WHZ) and/or mid-upper arm circumference (MUAC) will be included in the study.
- Informed consents will be given and drawn from mother or legal caregiver.
- Blood and stool samples will be taken before and after intervention in all participants. Markers which will be checked are: prealbumin, hsCRP, and brain-derived neurotropic factor (BDNF), from blood. Moreover, short-chain fatty acid (SCFA) and Bacteroides/Firmiculates ratio will be analyzed from stool.
- Block randomization will be conducted to allocate participants into two groups: intervention group who receive Striatin supplementation, and control group who receive placebo.
- The intervention will be given for 14 days. Neither researchers nor participants aware of the type of intervention (Striatin or placebo).
- Both groups will receive standard F-100 formula or oral nutrition therapy (ONS) as nutritional treatment for SAM, vitamin C, vitamin B complex, and folic acid.
- Intervention group will receive 1 sachet of Striatin and control group will receive 1 sachet of Placebo every 24 hours. Both Striatin and placebo will be dissolved in 10 ml of solvent syrup. The route of administration can be oral or via nasogastric tube.
- Weight will be measured every three days, and any complaint or side effect that appeared will be recorded every day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
We use block randomization (http://www.randomization.com) to allocate the participants into intervention or placebo. The participants will receive a sequentially-numbered, opaque, sealed envelope (SNOSE) which each sealed envelope is given a sequential number according to the order of recruitment and it contains the randomization code. Pharmacists are responsible for the distribution of the SNOSE and intervention products.
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe acute malnutrition (SAM) children based on WHZ and/or MUAC
- •Consents are given by parents/caregivers.
排除标准
- •SAM children with malignancy, liver cirrhosis, acute liver failure, severe kidney disorders, acute and chronic infections that attack the liver or other severe infections that require special treatment.
- •Subjects who require special anthropometric examinations (condition such as edema, organomegaly, amputation, cerebral palsy GMFCS > 2)
- •Children who have history of severe hypersensitivity to snakehead fish and/or cow's milk.
研究组 & 干预措施
Striatin
Participant in the intervention group will consume 1 sachet of the study product daily for 14 days. Each sachet contains 5 g of Striatin extract and 0.25 g of curcumin, to be dissolved in 10 ml of solvent syrup. The product is white in powder form, has sweet taste, and turns into a light-orange liquid after dissolution.
干预措施: Striatin (Drug)
Placebo
Participant in the control group will consume 1 sachet of Placebo daily for 14 days. Each sachet contains 4.89 g Mannitol, also to be dissolved in 10 ml of solvent syrup. The color and taste of the placebo match those of the intervention product to maintain blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute and relative weight increase
时间窗: Baseline, every three days, and Day 15.
Weight in grams
The change of Prealbumin
时间窗: Baseline and Day 15.
Prealbumin level
The change of hsCRP
时间窗: Baseline and Day 15.
hsCRP level
次要结局
- The change of SCFA(Baseline and Day 15.)
- The change ofB/F ratio(Baseline and Day 15.)
- Level of neurocognitive biomarker.(Baseline and Day 15.)
研究者
Moretta Damayanti Fauzi, MD
Child Health Department of Mohammad Hoesin Hospital
Universitas Sriwijaya