Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 317
- 试验地点
- 2
- 主要终点
- Change from baseline in bowel function
研究概览
简要总结
This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks.
The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.
详细描述
In this trial, a total of 300 adults (at least 18 years of age) diagnosed with irritable bowel syndrome (IBS) in accordance with the Rome IV criteria will be included. Patients will be recruited from gastroenterologists and primary care clinics across the USA. The study product, Fuco-N-Tetraose, will be taken daily throughout the course of the trial. All data will be collected through 4 web based surveys, and the participants will complete those at baseline before the intervention starts, and after 4, 8 and 12 weeks of intake of the study product.
The primary outcome of the study will be assessed by the Patients' Global Impression of Change (PGIC) scale. Other questionnaires used in the study includes the IBS specific Gastrointestinal Symptom Rating Scale (GSRS-IBS), the IBS Quality of Life Scale (IBS-QoL), the Participant Health Questionnaire-4 (PHQ-4), the Participant Health Questionnaire-12 (PHQ-12), and the Bristol Stool Form Scale (BSFS). All outcomes will be evaluated in all patients and in sub-groups of patients. i.e. subtypes by predominant bowel habit (diarrhea-predominant, constipation-predominant, or altered/mixed pattern), and lactose intolerant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give oral and written informed consent
- •Age minimum 18 years at enrolment
- •Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
- •Ability and willingness to understand and comply with the study procedures
- •Ability to read, speak and understand English
- •Free access to the internet via computer, tablet or smartphone to complete study surveys and also to allow for study team follow-up as needed.
排除标准
- •Participation in a clinical intervention study one month prior to screening visit and throughout the study.
- •Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
- •Pregnant or lactating or wish to become pregnant during the period of the study.
- •Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.
研究组 & 干预措施
Intervention
Daily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks.
干预措施: Fuco-N-Tetraose (Other)
结局指标
主要结局
Change from baseline in bowel function
时间窗: Baseline and after 4, 8 and 12 weeks of intake
Change from baseline in bowel function assessed as the proportion of bowel movements with abnormal fecal consistency measured with the Bristol Stool Form Scale
次要结局
- Change in patients' perception of body function(Baseline and after 4, 8 and 12 weeks of intake)
- Change in quality of life(Baseline and after 4, 8 and 12 weeks of intake)
- Change in IBS' interference in life in general(Baseline and after 4, 8 and 12 weeks of intake)
- Change on somatic symptoms(Baseline and after 4, 8 and 12 weeks of intake)
- Change in satisfaction with bowel habits(Baseline and after 4, 8 and 12 weeks of intake)
- Change in anxiety and depression(Baseline and after 4, 8 and 12 weeks of intake)
- Evaluate tolerability of fuco-N-tetraose(Baseline and after 4, 8 and 12 weeks of intake)