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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 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.
研究组 & 干预措施
Placebo
Placebo Comparator
Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
干预措施: Placebo (Dietary Supplement)
Litesse powder containing 12 g polydextrose
Experimental
12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
干预措施: Litesse powder containing 12 g polydextrose (Dietary Supplement)
Litesse powder containing 8 g polydextrose
Experimental
8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
干预措施: Litesse powder containing 8 g polydextrose (Dietary Supplement)
Litesse powder containing 4 g polydextrose
Experimental
4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
干预措施: Litesse powder containing 4 g polydextrose (Dietary Supplement)
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 (1)
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