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

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.