ISRCTN61742259已完成未知
Recovery study of L. casei DG® (Enterolactis® bevibile) in healthy children
SOFAR S.p.A.0 个研究点目标入组 20 人开始时间: 2018年6月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30498868 [added 02/05/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 3-12 years inclusive
- •2. Not classified as overweight based on the applicable body mass index chart for sex and age (SSP SGP. Growing curves. http://www.swiss- paediatrics.org/sites/default/files/ recommandations/courbes_de_croissances/pdf/perzentilen_2012_09_15_sgp_i.pdf. Accessed 20/06/2017)
- •3. Informed consent: informed consent of the parent(s)/legal representative(s) in accordance with Swiss regulations. Children aged =11 years provided informed consent; children aged from 3 to <11 years were not required to provide consent and were informed verbally
- •4. Full comprehension: ability of the children and/or their parent(s)/legal representative(s) to understand the full nature and purpose of the study, including possible risks and side effects; ability of the children and/or their parent(s)/legal representative(s) to co-operate with the investigator and to comply with the requirements of the entire study
排除标准
- •1. Clinically significant abnormal physical findings which could interfere with the objectives of the study
- •2. Unusual defecation frequency: on average more than 3 stools per day or less than 3 stools per week, as reported by the child/parent(s)/legal representative(s)
- •3. Food allergies (known or suspected); ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs/food supplements or allergic reactions in general, which the investigator considered could affect the outcome of the study
- •4. Intake of antibiotics within 1 month of screening
- •5. Medications, including over-the-counter medications and herbal remedies within 2 weeks of the start of the study.
- •6. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study. In particular:
- •6.1. Inflammatory intestinal chronic diseases
- •6.2. Intestinal diseases of infective origin
- •6.3. Viral or bacterial enteritis episodes in the 2 months before screening
- •6.4. Gastric or duodenal ulcer episodes in the 5 years before screening
- •6.5. Ongoing systemic infections
- •6.6. History of congenital infections
- •6.7. Neurological diseases
- •6.8. Metabolic diseases
- •6.9. Genetic diseases or chromosome anomalies
- •6.10. Primary or secondary immunodeficiencies
- •7. Participation in the evaluation of any investigational product in the 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that followed the last visit of the previous study and the first day of the present study
- •8. Recent history of drug or alcohol abuse
- •9. Unusual diets or substantial changes in eating habits in the 4 weeks before this study or vegetarian
- •10. Consumption of probiotics/prebiotics during run-in, including fermented milk probiotics (traditional yoghurt was allowed), probiotics food supplements or any other probiotic-containing product or prebiotic food supplement starting on Day -9
- •11. Pregnant (females only): urine pregnancy test for children of child-bearing potential
- •12. Compliance: presence of conditions that in the Investigator's opinion could lead to non-compliance to study requirements
研究者
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