Efficacy of Co-supplementation With Bifidobacterium Longum W11 and Colopectin in the Maintenance Therapy of Children With Functional Constipation: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Persistence of Constipation After Discontinuation of Macrogol Therapy
研究概览
简要总结
Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with functional constipation who are receiving macrogol and are candidates for weaning. Participants aged 2 to 6 years will be randomized to receive either the active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. The study will assess persistence of constipation after macrogol discontinuation, as well as stool consistency, distress during evacuation, soiling episodes, and treatment compliance.
详细描述
Functional constipation is one of the most common gastrointestinal disorders in childhood and is frequently associated with painful or infrequent defecation, stool retention, and reduced quality of life. In many children, maintenance treatment with macrogol is required for prolonged periods, and gradual weaning may be clinically challenging. Therefore, supportive dietary or microbiota-targeted strategies that may facilitate maintenance management and discontinuation of macrogol are of clinical interest.
Bifidobacterium longum W11 is a probiotic strain with potential effects on intestinal function and motility, while Colopectin contains prebiotic and fiber-related components that may help support bowel regularity. The combination is being investigated as a co-supplementation strategy in children with functional constipation during the maintenance phase of treatment.
This study is a randomized, double-blind, placebo-controlled, parallel-group trial in children aged 2 to 6 years with functional constipation who have been receiving maintenance-dose macrogol for at least 3 months and are candidates for treatment weaning. A total of 100 participants will be randomized in a 1:1 ratio to receive either Bifidobacterium longum W11 (Bowell®) plus Colopectin (Colopectin®) or placebo, administered once daily between meals in the afternoon for 4 weeks. After the treatment period, supplementation will be discontinued and participants will be monitored for an additional 4 weeks.
Clinical assessments will be performed at baseline (T0), at Week 4 (T1), and at Week 8 (T2). The primary endpoint is persistence of constipation, defined as 2 or fewer bowel movements per week, after discontinuation of macrogol therapy. Secondary endpoints include changes in stool consistency assessed using the Bristol Stool Scale, presence or absence of distress during evacuation, number of soiling episodes, and treatment compliance.
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
Participants, parents or guardians, care providers, investigators, and outcome assessors will remain blinded to treatment allocation. Active treatment and placebo will be provided in sachet form and administered according to the same schedule.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 to 6 years
- •Diagnosis of functional constipation
- •Receiving maintenance therapy with macrogol for at least 3 months
- •Candidates for weaning from macrogol therapy
排除标准
- •Children with intestinal meteorism or flatulence
- •Children diagnosed with organic constipation
- •History of previous abdominal surgery
- •Children with frailty or disabilities
- •Presence of other organ diseases or syndromes
研究组 & 干预措施
Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®)
Participants will receive co-supplementation with Bifidobacterium longum W11 (Bowell®) and Colopectin (Colopectin®) administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation.
干预措施: Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®) (Dietary Supplement)
Placebo
Participants will receive placebo (corn starch) formulated in sachets, administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation.
干预措施: Placebo (Other)
结局指标
主要结局
Persistence of Constipation After Discontinuation of Macrogol Therapy
时间窗: Week 8
Persistence of constipation defined as 2 or fewer bowel movements per week after discontinuation of macrogol therapy.
次要结局
- Change in Stool Consistency (Bristol Stool Scale)(Baseline, Week 4, and Week 8)
- Presence of Distress During Evacuation (Caregiver-Reported Assessment)(Baseline, Week 4, and Week 8)
- Number of Soiling Episodes(Baseline, Week 4, and Week 8)
- Participant Compliance With Assigned Intervention (Caregiver-Reported Administration)(Week 4)
研究者
Dr. Amjad Khan
Professor
Liaquat University of Medical & Health Sciences