NCT04587635已完成不适用
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- SBM
研究概览
简要总结
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind study
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-75, inclusive.
- •Self-reported symptoms of constipation for a minimum of 3 months.
- •Constipation symptoms according to the adapted Rome IV Diagnostic Questionnaire for Adults for Functional Constipation (Appendix 2) administered at screening.
- •Cleveland Clinic constipation score (CCCS) of 8-
- •Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener completed by site personnel.
- •Ability to understand the participant information sheet and instructions, and able to provide informed consent.
- •Access to a suitable smartphone device (Android or iOS) with ability to download and complete the study e-Diary daily for the duration of the trial.
排除标准
- •Pregnant women or breastfeeding.
- •Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Ulcerative Colitis, Coeliac disease, chronic diarrhoea).
- •Any clinically relevant abnormalities in the screening visit physical examination or alarm features in the medical history such as sudden unintentional weight loss (>10% in 3 months), frequent rectal bleeding not caused by anal fissures or hemorrhoids, recent change in bowel habit (<3 months), severe abdominal pain and stool positive for occult blood.
- •Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendectomy.
- •Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease.
- •Chronic usage of any medication that in the opinion of the investigator would impact gut motility two weeks prior to the initial administration of study product or up to a minimum of 5 times the half-life of the medication if it has a long half-life.
- •Illness that may preclude the participant's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start.
- •Participants with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility).
- •Ongoing alcohol, drug, or medication abuse (anamnesis only).
- •Self-reported symptoms of pelvic organ prolapse, such as feeling of pressure or fullness in the pelvic area, intra vaginal discomfort, painful intercourse and urinary problems.
- •Moderate or severe active local anorectal problems such as recurrent anal fissures, frequent bleeding, large prolapsing haemorrhoids.
- •Regular use of fiber (e.g. Fybogel, Lactulose) (i.e. no more than 1 standard dose) over the week prior to the screening visit and no more than 6 standard doses in the past 1 month prior to the screening visit.
- •Consumption of any type of yoghurts or probiotic-containing products, i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Saccharomyces such as Activia, Actimel, Yakult, in the 4 weeks prior to randomization (V0).
- •Participation in another study with any investigational product within 6 months of screening.
- •Participation in another constipation trial in the past year.
- •Investigator believes that the participant is physically or mentally unfit to participate in the trial
结局指标
主要结局
SBM
时间窗: Baseline to end of treatment, up to 6 weeks.
Change in mean frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to Week 6 in the treatment group compared to placebo. Frequency will be defined as the mean number of SBM for the 2-week run-in period prior to V0 and the final 2-week period of the intervention period.
次要结局
未报告次要终点
研究者
研究点 (1)
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