NCT04028258Unknown不适用
Randomized, Controlled, Crossover, Double-blind Clinical Trial on the Effect of a Mixture of Plant-based Fibers and Carbohydrates on Intestinal Transit in Children Aged 3 to 12 Diagnosed With Functional Constipation
Laboratorios Ordesa6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.
研究概览
简要总结
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:
- Group A: study product+wash out+control product
- Group B: control product+wash out+study product
详细描述
All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.
- Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.
- Control: Placebo supplement: maltodextrin and plum flakes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls aged 3 to 12
- •Diagnosis of functional constipation according to Rome IV criteria
排除标准
- •Regular use of a dietary fiber supplement, prebiotics or probiotics in the previous 30 days, or who would have been taking bulk-forming agents or laxatives in the 2 weeks prior to the study
- •Use of medications that cause constipation
- •Children with organic constipation such as Hirschsprung's disease, cerebral paralysis, anorectal and spinal cord abnormalities and metabolic diseases.
- •Patients who are not likely to complete follow-up
结局指标
主要结局
Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.
时间窗: From baseline to 8 weeks
Combined score between this parameters
次要结局
- Consistency of stool according to Bristol Stool Form Scale(From baseline to 8 weeks)
- Frequency of stool(From baseline to 8 weeks)
- Change in stool weight(From baseline to 8 weeks)
- Patient anthropometric measures: waist perimeter(Up to 8 weeks)
- Gastrointestinal symptoms related to the constipation(From baseline to 8 weeks)
- Patient anthropometric measures: size(Up to 8 weeks)
- Patient anthropometric measures: weight(Up to 8 weeks)
- Adherence record to the complement intake (Moriski Green test)(At 8 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant MelanomaNeoplasm MetastasisMelanomaNCT00055562Celgene Corporation274
已完成
3 期
PET/MRI in Patients With Suspected Prostate CancerProstate CancerNCT02659527Medical University of Vienna220
已完成
3 期
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.Neoplasm MetastasisMelanomaNCT00057616Celgene274
撤回
3 期
Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored SettingChronic PainNCT02138409INSYS Therapeutics Inc
已完成
2 期
Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster HeadachesCluster HeadacheNCT04066023Zosano Pharma Corporation42