Probiotics for chronic constipation: A randomized, prospective, placebo-controlled study

Chronic constipation significantly affects quality of life and is associated with symptoms such as abdominal pain, bloating, and incomplete bowel movements. Conventional treatments often fail to meet patient expectations, necessitating alternative approaches. GutBio Plus, a multispecies probiotic containing Lactobacillus and Bifidobacterium strains, was evaluated for safety and efficacy in managing chronic constipation in an open-label, placebo-controlled clinical trial.

This single-center study included 60 participants aged ≥18 years who were diagnosed with chronic constipation based on the ROME IV criteria. Participants were randomized into 2 groups using computer-generated random sequences: a GutBio Plus capsules group (n = 45) and a placebo group (n = 15) in a 3:1 ratio. Sample size was calculated to detect a clinically meaningful difference in complete spontaneous bowel movements (CSBM) with 90% power at α = 0.02. The intervention lasted 29 days, followed by posttreatment follow-up on day 45. The primary outcome was the proportion of participants achieving ≥3 CSBM per week at day 29. Outcomes included CSBM, stool consistency (Bristol Stool Form Scale), abdominal pain, bloating, and Patient Assessment of Constipation Quality of Life.

GutBio Plus significantly improved CSBM frequency, with 100% of participants in the treatment group achieving ≥3 CSBM per week by the end of treatment, compared to 7.69% in the placebo group (P < .05). Improvements in abdominal pain, bloating, and stool consistency were significantly greater in the treatment group than in the control group. The Patient Assessment of Constipation Quality of Life scores also showed marked improvements in physical discomfort, psychosocial well-being, and satisfaction in GutBio Plus users (P < .05). Sustained benefits were observed after the treatment.

GutBio Plus is a safe and effective treatment for chronic constipation, offering significant symptom relief and an improved quality of life. The sustained benefits highlight its potential as a reliable alternative to conventional laxatives.