NL-OMON54813招募中不适用
The effect of galacto-oligosaccharides (GOS) or chicory fructo-oligosaccharides (FOS) versus a placebo on bowel habits in children with functional constipation. - The Inside Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria, as considered by a medical doctor:
- •- Written informed consent obtained from parents or guardians of toddlers
- •meeting the eligibility criteria and those willing to comply with the
- •requirements of the study
- •- Aged 1-6 years (12 to 72 months at the day of inclusion) (at least 25% 1-2
- •years of age and at least 25% 2-3 years of age)
- •- Children that meet the following (Rome IV criteria): must include 1 month of
- •at least 2 of the following in infants up to 4 years of age:
- •1. 2 or fewer defecations per week
- •2. History of excessive stool retention
- •3. History of painful or hard bowel movements
- •4. History of large-diameter stools
- •5. Presence of a large fecal mass in the rectum
- •In toilet-trained children, the following additional criteria may be used:
- •6. At least 1 episode/week of incontinence after the acquisition of toileting
- •7. History of large-diameter stools that may obstruct the toilet
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Children who suffer from any other GI complaints than FC, known structural GI
- •abnormalities, or previous GI surgery
- •- Any condition that would make it unsafe for the child to participate. This
- •can include developmental delays associated with musculoskeletal or neurologic
- •conditions affecting the gastrointestinal tract. Children with underlying cause
- •of defecation disorder (for example: Hirschsprung*s disease, spina bifida
- •occulta, cystic fibrosis, or gastrointestinal malformations).
- •- Children with clinically significant cardiac, vascular, liver, pulmonary,
- •psychiatric disorders, severe renal insufficiency, human immunodeficiency
- •virus, acquired immunodeficiency syndrome, hepatitis B or C or known
- •abnormalities of haematology, urinalysis, or blood biochemistry, as checked by
- •the inclusion questionnaire.
- •- Children who are lactose intolerant for whom it is expected that low doses of
- •lactose could lead to diarrhoea or children that are allergic to cow*s milk
- •(GOS is derived from cow*s milk)
- •- Children who are allergic to fish
- •- Use of antibiotics or breast-feeding 4 weeks prior to the study
- •- Other medicines or food supplements, which can influence defecation and gut
- •microbiota 1 week prior to the study run-in period. This includes e.g. infant
- •formula(IF), follow-on formula (FOF) and young child formula (YCF), or products
- •with labelled pre-and probiotics in the previous week prior to the study run-in
- •- Children on other supplements/ medication that would affect bowel function
- •e.g. fibre supplements, and pre-, pro- and synbiotics (excluding escape
- •medication during the trial as mentioned in chapter 3 and 5.3) for the past
- •- Children that participate in another clinical trial.
研究者
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