Prospective, Randomized and Controlled Study for the Evaluation of the Effectiveness of a Supplement of Agave Tequilana Weber Var. Azul Fiber Derivatives vs Psyllium Plantago in Patients With Functional Constipation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- An increase of more than one complete evacuation from basal spontaneous from baseline at the end of active
研究概览
简要总结
Introduction: Constipation is one of the gastrointestinal disorders MOST frequent That Affects around 20% of the western population, being more frequent in the female gender (M1.5: H1). Constipation can be primary, When causes constipation associated With (medication, mechanical obstruction, spinal cord injury, etc.) and secondary. There are multiple therapeutic options for the management of constipation, changes in lifestyle Including, the intake of fiber, laxatives and pharmacological treatment and in selected cases (colonic inertia) surgery. The first option in the therapeutic management for Patients With constipation are changes in lifestyle, Among Which is the type of diet (increase in fiber intake, Which Has Been Associated With an improvement in the fecal matter and the evacuation frequency), liquid intake and exercise. Aim: To Evaluate the efficacy of the blue agave fructans Tequilana Weber in Patients With functional constipation Methods: This is a prospective, randomized, controlled and single blind study to determine the phase III efficacy of the blue agave fructans Tequilana Weber intake in subjects with functional constipation. In order to Achieve so, it is planned to include over 18 years of Patients age Fulfill the WHO as well as inclusion criteria The Rome III criteria for functional constipation. Statistical analysis plan: The data obtained will be analyzed with SPSS version 24. For continuous variables the results are presented in mean ± standard deviation when the variables are normally distributed or medians and percentiles otherwise and as frequency and percentages when they were categorical. For basal and subsequent comparison to the intra intervention groups, Student's t-test for paired samples (variables with normal distribution) or the Mann-Whitney U (variables without normal distribution) is used in the case of continuous variables and X2 or the McNemar test in the case of categorical variables. For comparison between groups ANOVA (variables with normal distribution) or Kruskal-Wallis (non-normal distribution variables) used for continuous variables and the same percentage of change obtained when the variables are continuous. Also an analysis of covariance (ANCOVA) was performed to control variables that might have an effect on the response variables.
详细描述
This is a prospective, randomized, controlled and single blind study to determine the phase III efficacy of the blue agave fructans Tequilana Weber intake in subjects with functional constipation.
In order to Achieve so, it is planned to include over 18 years of Patients age Fulfill the WHO as well as inclusion criteria The Rome III criteria for functional constipation. (See table below).
The phase of our study is designated based on article 66 of chapter II "On Pharmacological Research" of the Regulation of the General Law on Health in Research That defines PHASE III studies Follows as: It is the administration of a research drug to large groups of Patients (Usually external), to define ITS therapeutic utility and identification identify adverse reactions, interactions and external factors That May alter the pharmacological effect.
Patients of the institute will be called after invitations to Participate in Placing a protocol for Patients With constipation. Patients Who Have Not Been registered and meet the inclusion criteria May Also Participate.
The study to be Carried out will be Explained and read and, where appropriate', the informed consent will be signed by the Patient During the initial visit (Visit 1) of eligibility, Where the subject will be Given 2 questionnaires (see annexes), one They meet to determine if the ROME III criteria for functional constipation (FC) and another to ASSESS if the patient does not meet the criteria for irritable ROME III bowel syndrome (IBS) and a baseline breath test will be performed.
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
- Double (Participant, Investigator)
盲法说明
Powder is flavored in order to mask at minimum the differences between type of fibers
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
- 否
入选标准
- •Patients over 18 years old.
- •functional constipation ROME III criteria as
- •Subjects ≥55 years with recent colonoscopy (<3 years)
排除标准
- •Taking supplements of fiber in the last 2 months
- •Stimulant laxatives consumption chronically (Senna, Bisacodyl)
- •decompensated comorbidities (example: uncontrolled diabetes mellitus HbA1c> 9%, decompensated Organ failure, decompensated hypertension (untreated or TA> 160 mmHg systolic and 95 mmHg diastolic)
- •Using digital maneuvers or enemas to achieve evacuation
- •Personal history of active or previous cancer
- •abdominal surgery (except appendectomy, cholecystectomy, hysterectomy)
- •Presence of alarm data in the last 6 months (trans-rectal bleeding, unexplained weight loss, abdominal pain)
- •Use of drugs known promote constipation (opioid derivatives, calcium channel blockers, anticholinergics tricyclic antidepressants type)
- •Prostration (immobility or poor mobility)
- •Diseases such as untreated hypothyroidism with hormone replacement, and diseases associated with hypercalcemia that promote constipation
- •Other causes of secondary constipation
- •Meet criteria for constipation predominant irritable bowel
- •Pregnancy.
结局指标
主要结局
An increase of more than one complete evacuation from basal spontaneous from baseline at the end of active
时间窗: 15 days
Effect of supplementation of fructans Tequilana Weber blue agave in increasing at least one complete evacuation from basal spontaneous. Spontaneous evacuation It is defined as an evacuation in the absence of use of laxatives, suppositories or enemas and complete evacuation is defined as spontaneous evacuation to that sensation of incomplete emptying of the rectal ampulla.
次要结局
- V. To evaluate the impact of serum glucose concentration and HbA1c fasting serum of subjects before and after addition of fructans Tequilana Weber blue agave(8 weeks)
- Effect of supplementation of fructan Weber blue agave Tequilana in the frequency of bowel movements(15 days)
- Change in the classification of Bristol(15 days)
- Evaluate the impact of the concentration of short-chain fatty acid, particularly butyrate, in the feces of subjects before and after addition of fructans Tequilana Weber blue agave.(8 weeks)
- IV. Evaluate the impact of supplementation fructans Weber blue agave Tequilana the microbiota(8 weeks)
研究者
Enrique Coss-Adame
Gastroenterology
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran