PHGG-LGG Synbiotic in Pediatric Functional Constipation (PHGG-LGG-FC)
Effects of a Partially Hydrolyzed Guar Gum and Lacticaseibacillus Rhamnosus GG Combination on Clinical Outcomes and Microbiota in Children With Functional Constipation
研究概览
地位
条件
详细说明
Functional constipation is common in children and has been associated with gut microbiota dysbiosis and impaired short-chain fatty acid production. Synbiotics combining prebiotics and probiotics may improve stool characteristics and intestinal fermentation.
This study investigated whether daily supplementation with PHGG (4.3 g) plus LGG (1×10⁹ CFU) for 12 weeks improves stool frequency, consistency, gastrointestinal symptoms, and microbiota composition compared with standard dietary advice alone. Whole-genome shotgun metagenomics was performed in a subset of participants to characterize microbial and functional changes.
This study was registered retrospectively on ClinicalTrials.gov because it was initiated as an investigator-initiated academic study without initial intent for regulatory submission. Registration was completed after study completion to ensure transparency and compliance with journal and international reporting standards.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Istanbul、土耳其（türkiye）、34000
- University of Health Sciences, Sancaktepe Training and Research Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥4 years
- Diagnosis of functional constipation per Rome IV
- Parental informed consent
Exclusion Criteria:
- Organic causes of constipation
- Chronic medication use
- Antibiotics or biotics within 8 weeks
- Age <4 years
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LGG-PHGG
PHGG + LGG Synbiotic 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG Once daily, oral, 12 weeks Plus standardized dietary and lifestyle counseling |
4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG Once daily, oral, 12 weeks Plus standardized dietary and lifestyle counseling
Dietary and lifestyle counseling only
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|
有源比较器：Control
Dietary and lifestyle counseling only
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Dietary and lifestyle counseling only
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical treatment success at Week 12
大体时间：12 weeks
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Clinical treatment success at Week 12, defined as: ≥3 spontaneous bowel movements per week AND Bristol Stool Scale type 3-4 AND No longer fulfilling Rome IV criteria |
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Symptom Improvement
大体时间：12 weeks
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Time (in days) from initiation of the intervention to the first reported improvement in constipation-related symptoms
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12 weeks
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|
Microbiota
大体时间：12 weeks
|
Gut microbiota composition changes
|
12 weeks
|
|
Time to Second Improvement Milestone
大体时间：Baseline to 12 week
|
Time (in days) from initiation of the intervention to the second clinically meaningful improvement milestone, defined as sustained improvement in bowel movement frequency and/or stool consistency accompanied by reduction in associated gastrointestinal symptoms, as documented in daily follow-up records.
|
Baseline to 12 week
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School Absenteeism
大体时间：Baseline and Week 12
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Number of school days missed and presence of school absenteeism due to constipation-related symptoms, as reported by parents during the study period.
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Baseline and Week 12
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2024/197
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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