NCT04716868: SATWAVPP

Evaluation of a Supplement of Agave Tequilana Weber Azul vs Psyllium Plantago in Patients With Functional Constipation

Status unknown NA Last updated 17 February 2021

What this trial tests

NA trial testing Agave Fructans 5 g in Functional Constipation in 60 participants. Status unknown.

Timeline

18 July 2019

Primary endpoint
18 June 2021

18 August 2021

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	18 July 2019
Primary completion	18 June 2021
Estimated completion	18 August 2021
Sites	1 location across Mexico

Drugs / interventions tested

• Agave Fructans 5 g
• Agave Fructans 10 g
• Agave Fructans 5 g + Maltodextrin 10 g
• Psyllium plantago

Conditions studied

• Functional Constipation — all drugs for Functional Constipation →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

Adults 18 to 65, any sex, with Functional Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Agave tequilana Fructans Versus Psyllium plantago for Functional Constipation : Randomized Double-blind Clinical Trial.
   Coss-Adame E, García-Cedillo MF, Bustillo-Armendáriz G, Huerta-de la Torre MF, et al · · 2024 · cited 3× · PMID 37389917 · DOI 10.1097/mcg.0000000000001888