Agave tequilana Fructans Versus Psyllium plantago for Functional Constipation : Randomized Double-blind Clinical Trial.

Abstract

Goal: The aim of this study was to evaluate the efficacy of supplementation with Agave tequilana Weber blue variety fructans (Predilife) in the improvement of symptoms in functional constipation.

Background: Fiber supplementation is the first-line treatment for constipation. Fibers-like fructans have a known prebiotic effect.

Materials and methods: A randomized, double-blind, study comparing agave fructans (AF) against psyllium plantago (PP). Four groups were randomized. Group 1: AF 5 g (Predilife), group 2: AF 10 g (Predilife), group 3: AF 5 g (Predilife)+10 g maltodextrin (MTDx), and group 4: PP 5 g+10 g MTDx. The fiber was administered once daily for 8 weeks. All fibers were similarly flavored and packaged. Patients kept their usual diet and fiber sources were quantified. Responders were defined as ≥1 complete spontaneous bowel movement from baseline to 8 weeks. Adverse events were reported. The study was registered in Clinicaltrials.gov with registration number NCT04716868.

Results: Seventy-nine patients were included (group 1: 21, group 2: 18, group 3: 20, and group 4: 20), of which 62 (78.4%) were women. The responders were similar across groups (73.3%, 71.4%, 70.6%, and 69%, P >0.050). After 8 weeks, all groups significantly increased complete spontaneous bowel movements, showing the greatest increase in spontaneous bowel movements in group 3 ( P =0.008). All groups improved in symptoms, stool consistency, and quality of life. Diet and fiber intake were similar between groups. Adverse events were mild and similar between groups.

Conclusions: AF (Predilife) are as effective at different doses and combined with MTDx as PP and are a feasible option for the treatment of functional constipation.