NCT02314936已完成2 期
Dose-ranging Efficacy of Supplementation With Polydextrose, a Dietary Fibre, on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Change in Colonic Transit Time From Baseline to Day 15
研究概览
简要总结
This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Age between 18 and 70 years.
- •Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).
- •If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
- •Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).
- •Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- •Must meet 2 or more of the following criteria:
- •Straining during at least 25% of defecations, Lumpy or hard stools 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 maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- •Fewer than three defecations per week
- •Loose stools are rarely present without the use of laxatives
- •Insufficient criteria for irritable bowel syndrome
- •Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- •Consent to the study and willing to comply with study product and methods.
- •Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
排除标准
- •Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)
- •Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.
- •Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).
- •Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.
- •Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).
- •Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.
- •Anticipated major dietary or exercise changes during the study.
- •Systemic steroid use, within 1 month before screening.
- •Eating disorder.
- •Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).
- •History of alcohol, drug, or medication abuse.
- •Pregnant or lactating female, or pregnancy planned during study period.
- •Participation in another study with any investigational product within 60 days of screening.
- •Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
- •Subject under administrative or legal supervision.
- •Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
结局指标
主要结局
Change in Colonic Transit Time From Baseline to Day 15
时间窗: Baseline and Day 15
Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.
次要结局
- Change in Stool Frequency From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
- Change in the Bloating Severity From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
- Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15(Baseline and Day 15)
- Change in Bowel Function Index From Baseline to Day 15(Baseline and Day 15)
- Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15(Baseline and Day 15)
- Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15(Baseline and Day 15)
- Change in Stool Consistency From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
- Change in the Degree of Straining During Defecation From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
- Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
- Overall Product Satisfaction(Assessed at Day 15 (end of study))
- Change in the Severity of Abdominal Discomfort From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
研究者
研究点 (2)
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