Clinical efficacy and gastrointestinal hormonal effect of Lactobacillus rhamnosus combined with lactulose for treatment of irritable bowel syndrome with constipation.

OBJECTIVE

This study aimed to explore the clinical efficacy of Lactobacillus rhamnosus combined with lactulose for the treatment of irritable bowel syndrome with constipation (IBS-C) and its effect on gastrointestinal hormones.

METHODS

A prospective, randomized, double-blind trial was conducted with three groups: control (n=45, mosapride citrate tablets), monotherapy (n=44, lactulose + control regimen), and combination (n=45, Lactobacillus rhamnosus + monotherapy regimen). The primary outcome measure was clinical efficacy. Secondary outcomes included the Bristol Stool Scale (BSS), Irritable Bowel Syndrome Quality of Life Score (IBS-QoL), Perceived Stress Scale (PSS), Irritable Bowel Syndrome Severity Score (IBS-SSS), gut microbiota, and gastrointestinal hormones assessed at days 0, 28, and 56, along with safety observations.

RESULTS

Following a 56-day intervention period, the combination group achieved 100.00% clinical effectiveness, significantly higher than the monotherapy (93.18%) or control groups (75.56%). Fecal consistency responders were 84.44% in the combination group vs. 47.73% (monotherapy) and 28.89% (control). The combination group showed higher IBS-QoL scores, lower PSS scores, and reduced IBS-SSS scores (P < 0.05). Intestinal flora analysis revealed decreased Ruminococcaceae and increased Fibrobacteraceae and Campylobacteraceae in the combination group. Gastrointestinal hormones improved, with increased motilin and decreased vasoactive intestinal peptide (P < 0.05). There was no significant difference in the incidence of adverse events among the three groups (P > 0.05).

CONCLUSION

Lactobacillus rhamnosus combined with lactulose significantly improves IBS-C symptoms and quality of life, and positively modulates intestinal flora and gastrointestinal hormones.