The effect of galacto-oligosaccharides in constipated adults - TRANSIT study

FrieslandCampina Research0 个研究点目标入组 132 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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):
•Fewer than three (3) bowel movements per week.
•And one or more of the criteria below:
•* Straining during at least 25% of all defecations
•* Lumpy or hard stools (BSFS 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 defecation (e.g., digital
•evacuation, support of the pelvic floor)
•*Willingness to abstain from laxatives during the study

•- 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 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
•-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

发起方

FrieslandCampina Research