NL-OMON23365已完成不适用
The effect of galacto-oligosaccharides in constipated adults
FrieslandCampina0 个研究点目标入组 132 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
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
入选标准
- •Substantial:
- •Males and females
- •Age = 18 years
- •BMI =18,5 and = 28,0 kg m2.
- •Healthy as assessed by the NIZO health questionnaire
- •Self-reported constipation according to the Rome IV criteria with the following criteria (for the last 3 months):
- •oFewer than three bowel movements per week.
- •oAnd one or more of the criteria below:
- •?straining during at least 25% of all defecations
- •?lumpy or hard stools (Bristol Stool Form Scale 1-2) in at least 25% of defecations,
- •?sensation of incomplete evacuation for at least 25% of defecations,
- •?sensation of anorectal obstruction/blockage for at least 25% of defecations,
- •?manual manoeuvres to facilitate at least 25% of defaecaltion (e.g., digital evacuation, support of the pelvic floor)
- •Procedural:
- •Ability to follow Dutch verbal and written instructions
- •Availability of internet connection
- •Signed informed consent
- •Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned.
- •Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years.
- •Willing to comply with study procedures, including collection of stool samples and alcohol restriction of maximum 2 consumptions per day
- •Willing to abstain from non-prescription laxatives (starting at least 2 weeks before the start of the baseline period)
- •Willing to abstain from drugs use during the study
排除标准
- •Substantial:
- •Major abdominal surgery interfering with GI function
- •Major co-morbidities, such as diagnosed inflammatory bowel disease, diagnosed celiac disease, diagnosed diverticulitis, a history of gastrointestinal tumors and other unforeseen co-morbidities, that may have an impact on the study results (as decided by the medical investigator).
- •Use of medication that may affect the results of the investigational product, such as physician prescribed laxatives, and medication that influences the motility of the GI tract.
- •Use of antibiotics 90 days before the start of the study
- •Use of strict diets (vegan diet, gluten free diet, or crash-diet with use of meal replacers)
- •Self-reported lactose-intolerance
- •Self-reported cow’s milk protein allergy
- •Diagnosed diabetes
- •Pregnant and lactating women
- •Expected change in lifestyle within 14 days before and during the trial period (i.e. diet, physical activity, smoking, alcohol consumption and medication use)
- •History of side effect with the use of prebiotic supplements
- •Use of alcoholic beverages for men > 28 units/week and >4/day; for women: >21 units/week and >3/day
- •Procedural:
- •Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results.
- •Participation in any clinical trial including blood sampling and/or administration of substances starting 1 month prior to study start and during the entire study.
- •Personnel of NIZO or FrieslandCampina, their partner and their first and second degree relatives.
研究者
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