NCT05714410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 As Compared to Placebo (Typhoon 2)
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年1月25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
- 160
- 试验地点
- 2
- 主要终点
- Change in Spontaneous Bowel Movements
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 as Compared to Placebo (Typhoon 2)
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)
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-
- •Adapted Rome IV Criteria of functional constipation* or IBSconstipation** for a minimum of 3 months
- •*1-2 SBM/week and at least 1 of the following at least 30% of the time:
- •Bristol stool scale 1-2
- •Sense of incomplete evacuation
- •Sense of stool blockage
- •Need of digital maneuvers
- •Subjects with IBS-C: the above constipation criteria + abdominal pain are allowed.
- •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.
- •Organic chronic gastrointestinal disease or complication (such as, but not limited to, Inflammatory Bowel Disease, Microscopic colitis, Eosinophilic gastroenteritis, Radiation-related enterocolitis, Coeliac disease).
- •Subjects with a diagnosed food allergy or hypersensitive to any of the components of the study product.
- •Subjects with chronic diarrhea.
- •Active peptic ulcer.
- •Major gastrointestinal or colonic surgery (such as, gastric bypass or any other obesity or metabolic interventions including endoscopic procedures or devices, any gastro-intestinal or colonic resection); cholecystectomy and appendectomy are allowed.
- •Neurologic or other clinically significant comorbid diseases that may affect gastrointestinal function, such as multiple sclerosis, spinal cord injury or Hirschsprung disease.
- •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 clinically significant (as per physician judgement) co-morbid illnesses such as cardiovascular, endocrine (e.g. hypothyroidism, diabetes), renal, or other chronicdisease (e.g. reduced mobility or increased fragility).
- •Active alcohol, drug, or medication abuse (as per clinician judgement).
- •Self-reported symptoms suggestive of pelvic organ prolapse as per clinician judgement, 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 hemorrhoids.
- •Any clinically relevant abnormalities detected during the physical examination or any 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.
- •Regular (i.e. daily or weekly) use of PHGG within 6 months of screening.
- •Participation in another study with any investigational product within 6 months of randomization for drug study and within 2 months of randomization for a nutritional study.
- •Investigator believes that the participant is physically or mentally unfit to participate in the trial.
- •Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
- •Any participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
结局指标
主要结局
Change in Spontaneous Bowel Movements
时间窗: 6 weeks
Change in mean weekly frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to end of treatment period. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to V0, for baseline, and during the final 2 weeks of the intervention period, for end of treatment.
次要结局
- Change in stool consistency(6 weeks)
- Change in frequency of Complete Spontaneous Bowel Movements(6 weeks)
- Change in constipation related symptoms(6 weeks)
研究者
研究点 (2)
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