NCT04127656终止不适用
Symptom Changes in Infants Fed an Amino Acid-based Formula
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Food Allergy Symptom Improvement
研究概览
简要总结
To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is judged to be in good health as determined from subject's medical history
- •Subject is from a full-term birth with a gestational age of 37-42 weeks
- •Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- •Subject has been documented to have CMPA and/or multiple food allergies, FPIES or gastrointestinal eosinophilic disorders.
- •Subject is experiencing persistent feeding intolerance symptoms including any of the following: regurgitation/vomiting associated with feeding (within 1 hour), constipation, diarrhoea, hematochezia (blood in the stool), crying, gassiness (wind), and/or skin rash/eczema.
- •Parent(s) confirm their intention to feed their infant study product during the study period.
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrolment through the duration of the study, unless instructed otherwise by their healthcare professional.
- •Infant using medications (OTC medications for gas [wind]), home remedies (such as juice for constipation), herbal preparations, prebiotics, probiotics or rehydration fluids that might affect Gl tolerance may not be enrolled unless the parent agrees to discontinue the use of these agents prior to enrolment or a healthcare professional recommends their continued use.
- •Subject's parent(s) has voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy regulation authorisation prior to any participation in the study.
排除标准
- •Subject is receiving steroids or antibiotics
- •Subject is tube-fed
- •Subject has received an amino acid-based formula
- •Subject has been diagnosed with: Short bowel syndrome, Inflammatory bowel disease, Pancreatic disease, Protein maldigestion (malnutrition), Mast cell disorder
- •Subject is participating in another study that has not been approved as a concomitant study by AN
结局指标
主要结局
Food Allergy Symptom Improvement
时间窗: Baseline to Day 28
Parent Completed Symptom Diary
次要结局
- Time to Symptom Resolution or Reduction(Baseline to Day 28)
- Study Formula Intake(Baseline to Day 28)
- Change in Length(Baseline to Day 28)
- Change in Weight(Baseline to Day 28)
研究者
研究点 (6)
Loading locations...
相似试验
终止
不适用
Evaluation of the Efficacy of an Amino Acid Based Formula in InfantsCow's Milk AllergyNCT01584245Mead Johnson Nutrition32
已完成
不适用
A Study to Monitor the Use of an Amino Acid-Based Infant FormulaEosinophilic Gastrointestinal DisordersMalabsorption/MaldigestionMultiple Food AllergiesShort Bowel SyndromeCow's Milk Protein AllergyNCT02953223Société des Produits Nestlé (SPN)144
已完成
不适用
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein HydrolysatesCow Milk AllergyNCT01940068United Pharmaceuticals86
尚未招募
不适用
Study of food allergen sensitization in infancy utilizing allergen components (prospective study)Food allergyJPRN-UMIN000048496ational Hospital Organization Sagamihara Hospital250
已完成
不适用
Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk AllergyCow's Milk AllergyNCT01622426Federico II University60