ISRCTN34762792已完成未知
Evaluation of the impact of fermented milk containing Lactobacillus casei strain Shirota (LcS) on stool consistency
Yakult Honsha European Research Centre for Microbiology ESV0 个研究点目标入组 64 人开始时间: 2019年6月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
2024 Results article in https://doi.org/10.3390/nu16152469 (added 01/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent obtained before any study-related activities
- •2. Healthy female or male aged 18–65 years (inclusive)
- •3. Produces hard stool (BS1 and 2 stools), with a frequency of 50% or more during 2 weeks of screening data period
- •4. Does not take probiotics 2 weeks before the start of screening data collection. If the patient takes probiotics, a washout period of 2 weeks is needed
- •5. Is willing and able to collect every stool at home during 3 consecutive days and this 3 times during the treatment period, to store the samples in appropriate conditions and to return the samples within the required timeframe
- •6. Is willing and able to complete a diary during the screening, baseline and treatment period in order to collect information about the form of the stools (based on the Bristol Stool Form Scale classification) and bowel habit
- •7. Prepared not to change the current drinking, eating, smoking and exercising habits during the course of the study
- •8. Understands the Dutch or English language (reading, writing, speaking)
排除标准
- •1. Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in the study
- •2. Is vegetarian or vegan
- •3. Is treated (i.e., currently treated, treated within 1 month before screening) by a doctor for her/his constipation
- •4. Has any history of gastrointestinal surgery except for appendectomy
- •5. Has any history of chronic/severe gastrointestinal disorders
- •6. Females of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods (e.g., oral contraceptive, condom, intrauterine device, abstinence)
- •7. Is unable to refrain from or anticipates the use of antibiotics and/or laxatives
- •8. Has any history of drug and/or alcohol abuse
- •9. Has milk allergies
- •10. Is intolerant to lactose
- •11. Any clinically significant disease which in the Investigator’s opinion could interfere with the safety of study participants or with the results of the study
- •12. Use of disallowed concomitant medications and concomitant products within 2 weeks before the screening period, depending if a wash out period for probiotics is needed
- •13. Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the Investigator’s opinion could interfere with the results of the study
- •14. Previous participation in this study. Participation is defined as screened. Re-screening is therefore not allowed
- •15. Participation in another interventional clinical study or receipt of any investigational product within 1 month before the screening period
研究者
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