Nutrition to Relieve IBS Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Stool frequency
研究概览
简要总结
Rationale: Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heterogeneity of the patients and the complicated pathology in which not all mechanisms are understood. Based on results of in vitro screening within the IBSQUtrition project, we selected promising dietary supplements for validation of their potential beneficial effects on stool pattern in IBS-Constipation (IBS-C) patients.
Objective: The primary objective is to determine the effects of a 4-week intervention with either a prebiotic supplement or a probiotic supplement on stool pattern (including stool frequency, consistency, and volume) in IBS-C patients. The secondary objective is to determine the effects if this intervention on GI complaints and quality of life in IBS-C patients.
Study design: A double-blind, randomized, placebo-controlled trial will be conducted with three parallel intervention arms Study population: 180 adult (18-70 yrs) IBS patients with a constipation-predominant subtype Intervention: A 4 week run-in period will be followed by a 4-week intervention period with three parallel arms: 1) prebiotic supplement, 2) probiotic supplement, and 3) Placebo supplement, during which the study participants consume the respective supplement twice per day.
Main study parameters/endpoints: The primary study parameter is stool pattern: stool frequency, stool consistency; and stool volume. The secondary study parameters are gastrointestinal complaints, Quality of Life, and HADS.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants have to invest about 14.5 hours of their time in this study mainly to complete several questionnaires (short daily questionnaire, longer questionnaires at three occasions), which is conveniently all possible from home. They have to comply to consume a supplement twice daily for four weeks. At two time points they have to collect their stool for five consecutive days. There are limited risks for the study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS patients that meet the Rome IV criteria + additional criteria specific for the constipation-predominant subtype, based on the most frequent self-reported stool types using the Bristol stool chart (BSC). These criteria will be assessed via the inclusion questionnaire and will be evaluated by the medical supervisor.
- •Male and female adults, aged 18-70 years.
- •Have a Body Mass Index (BMI) between 18.5 and 30 kg/m2 (self-reported).
- •Willing to keep a stable dietary pattern throughout the study.
- •Having a smartphone to fill out the daily questionnaires
排除标准
- •Having a disease that may interfere with the outcomes of this study, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism.
- •History of intestinal surgery (excluding appendectomy or cholecystectomy) or endometriosis.
- •Use of medication that can interfere with the study outcomes, including antidepressants (allowed when it is not subscribed for mental depression), codeine, and antibiotics, as judged by the medical supervisor MD Ben Witteman.
- •Use of prescribed laxatives. Over-the-counter laxatives are allowed, but intake should be either stopped before the start of the study or kept stable during the complete study period.
- •Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements dedicated to bowel function improvements. Some supplements are allowed, but intake should be kept stable during the whole study period (Supplements will be judged by the medical supervisor MD Ben Witteman).
- •If applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool pattern and wellbeing.
- •Participation in another clinical trial at the same time.
- •Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition & Health, Wageningen University.
- •Alcohol intake ≥ 2 (women) or ≥ 4 (men) glasses of alcoholic beverages per day.
- •Abuse of illicit drugs, soft drugs, and nitrous oxide.
结局指标
主要结局
Stool frequency
时间窗: Change after the intervention, measured at week 1, week 4 and week 8
Number of stools per day will be questioned
stool volume
时间窗: Change after the intervention, measured at week 4 and week 8
Participants will weigh every stool that they have during 5 days
Stool consistency
时间窗: Change after the intervention, measured at week 1, week 4 and week 8
Will be assessed using the Bristol stool Chart
次要结局
- Irritable Bowel Syndrome severity(during week 1, week 4 and week 8 of the study)
- Constipation related quality of life(during week 1, week 4 and week 8 of the study)
- Constipation severity(during week 1, week 4 and week 8 of the study)
- Mental wellbeing(during week 1, week 4 and week 8 of the study)
- Dietary intake(during week 1, week 4 and week 8 of the study)
- gastro-intestinal complaints(daily for 8 weeks)
研究者
Diederik Esser
Project leader clinical trials
Wageningen University and Research