NCT06381193已完成不适用
Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics
Centros de Investigación de Nutrición y Salud2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月3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
- 80
- 试验地点
- 2
- 主要终点
- 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.
研究概览
简要总结
The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:
- To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
- To evaluate the stool consistency after 8 weeks (Bristol scale).
- To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.
Participants are randomized into the following groups:
- Group A: 20 assigned to probiotic + placebo
- Group B: 20 assigned to prebiotic + placebo
- Group C: 20 assigned to probiotic + prebiotic
- Group D: 20 assigned to the placebo + placebo
Participants took 4 units of product per day (2 of each assigned product) for 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women between 18-
- •BMI 18.5-39.9 kg/m2
- •According to the ROME IV criteria, patients with functional constipation who meet the following conditions for at least the last three months and with symptoms for at least 6 months before diagnosis:
- •The presence of two or more of the following criteria:
- •Excessive straining at least in 25% of bowel movements.
- •Hard stools (types 1-2 on the Bristol scale) at least in 25% of stools.
- •Sensation of incomplete evacuation at least in 25% of the stools.
- •Sensation of anorectal obstruction or blockage at least in 25% of bowel movements.
- •Manual maneuvers to facilitate defecation at least in 25% of stools.
- •Less than three complete spontaneous bowel movements per week.
- •Diarrhea rarely occurs without the use of laxatives.
- •Insufficient criteria for the diagnosis of irritable bowel syndrome.
- •Or, according to the ROME IV criteria, patients who suffer from constipation type irritable bowel syndrome defined as a syndrome in which there is abdominal pain with at least two of the following three characteristics:
- •Related to defecation.
- •Associated with change in stool frequency.
- •Associated with a change in stool shape or appearance.
- •Patients who have signed the informed consent.
- •Patients with the ability to understand and carry out the study procedures.
- •Women participating in the study must meet one of these two conditions:
- •Women without the possibility of becoming pregnant, defined as any woman who has undergone surgical sterilization or is in a postmenopausal state.
- •Women with the possibility of becoming pregnant who regularly use a highly effective contraceptive method (i.e., hormonal contraception, intrauterine device, condoms, sterilization of the male partner (vasectomy), or complete sexual abstinence) while participating in the study.
排除标准
- •Minors under 18 or over 65 years of age.
- •Patients diagnosed with other chronic diseases ( Parkinson's or other dementias, cerebral palsy, heart attack, tetraplegia, hemiplegia, intellectual disability, multiple sclerosis, amyotrophic lateral sclerosis (ALS), cystic fibrosis, congenital metabolic diseases, eating disorders).
- •With previous surgeries in the gastrointestinal tract.
- •Patients with scheduled surgical interventions during the study.
- •Patient treated with anticoagulants.
- •Patients who have used laxative treatment during the 15 days before the start of the study.
- •Patients who have been treated with antibiotics in the last month.
- •Usual treatment with opioid analgesics.
- •Consumption of supplements with probiotics or prebiotics during the last two weeks before inclusion in the study.
- •Patients diagnosed or with sufficient criteria for the diagnosis of ulcerative colitis, Crohn's disease, presence of intestinal obstruction or malignant disease in the gastrointestinal tract.
- •Participation in another clinical trial with an investigational medication 30 days before the start of the study.
- •Pregnant or breastfeeding women.
- •Patients with hypersensitivity, allergy or intolerance to any of the components of the food supplements in the study
结局指标
主要结局
1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.
时间窗: 8 weeks
次要结局
- To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale).(8 weeks)
- To evaluate the stool consistency (Bristol scale).(8 weeks)
- To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20)(8 weeks)
研究者
Ismael San Mauro Martin
Principal Investigator
Centros de Investigación de Nutrición y Salud
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Efficacy on Overweight With Oral Supplemenation of Probiotics and PrebioticsOverweightNCT05710055Shenzhen Precision Health Food Technology Co. Ltd.,200
Unknown
不适用
Antipsychotic Effects of Probiotics and Prebiotics on Patients With SchizophreniaSchizophreniaNCT04291469First Affiliated Hospital Xi'an Jiaotong University200
已完成
不适用
The Effect of Probiotic and Prebiotic Use on Fibromyalgia SyndromeFibromyalgiaNCT04607278Ankara University53
已完成
不适用
Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord InjurySpinal Cord InjuriesNCT04659408Swiss Paraplegic Research, Nottwil14
已完成
2 期
Probiotic Use for Recovery Enhancement From Long COVID-19Post-Acute COVID-19 SyndromeNCT06643299Rush University Medical Center194