NL-OMON54825招募中不适用
The effect of galacto-oligosaccharides (GOS) versus a placebo on defecation parameters and microbiota in healthy children with hard or lumpy stools - The Inside Study II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
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 the researchers:
- •1. 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
- •2. Aged 1-6 years (12 to 72 months at the day of inclusion)
- •3. Hard or firm stools (score of 1 or 2 according to the mBSFS) for more than
- •50% of the defecations in the past month, as reported by parents and confirmed
- •by the diary of the first week of the study.
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 FC according to the Rome IV criteria: Must include 1
- •month of at least 2 of the following in infants and children up to 4 years of
- •o 2 or fewer defecations per week
- •o History of excessive stool retention
- •o History of painful or hard bowel movements
- •o History of large-diameter stools
- •o Presence of a large fecal mass in the rectum
- •In toilet-trained children, the following additional criteria may be used:
- •o At least 1 episode/week of incontinence after the acquisition of toileting
- •o History of large-diameter stools that may obstruct the toilet
- •- Children who suffer from GI complaints, 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 allergic to fish
- •- Use of antibiotics 4 weeks prior to the study run-in period.
- •- Children on other supplements/ medication that would affect bowel function 1
- •week prior to the study run-in. This includes e.g. breast milk, fibre
- •supplements, pre-, pro-, and synbiotics, infant formula, follow on formula or,
- •young child formula
- •- Children that participate in another clinical trial.
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