Abstract:
Objectives: Irritable Bowel Syndrome (IBS) has become a global functional gastrointestinal disorder. Irritable bowel syndrome with predominant diarrhea (IBS-D) is due to disturbed gut-brain interactions. Although IBS-D was not a life-threatening disease, it seriously affected the quality of life of patients and caused great economic and mental burden to individuals, society and families. The purpose of this trial is to investigate the therapeutic effect of Clostridium butyricum capsule combined with inulin-based probiotic on patients with IBS-D and to analyze the alterations in the intestinal flora of the patients.
Design: Prospective, randomized, controlled study.
Setting: One hospital in China (XXX hospital).
Patients: A total of 80 patients aged 35-75 years with primary diagnosis of irritable bowel syndrome with predominant diarrhea were included in this study. Participants were randomly divided into the Combined group (n=40) or the Placebo group (n=40).
Interventions: Participants in the Combined group received live Clostridium butyricum capsules (oral, 400 mg/dose, 3 times/day) combined with probiotics (inulin, oral, 6 g/day), and the Placebo group received visually corresponding indistinguishable placebo decoction. All patients will receive treatment for eight weeks and their efficacy and safety will be evaluated on the 8th week.
Outcomes and Main Results: The primary outcome was the difference between the two groups in the IBS Symptom Severity Scale (IBS-SSS) score, IBS Global Improvement Scale (IBS-GIS) score, and symptom relief after 8 weeks of treatment. Secondary endpoints were differences in the diversity of the gut microbiota and the abundance of the bacteria between the two groups at the 8th week. Compared to the placebo group, the combination group significantly improved IBS-GIS (6.7±1.6 vs. 5.2±1.2, P = 0.003) and IBS-SSS scores (329.5±60.6 vs. 319.2±51.2, P = 0.042), as well as domain-specific scores related to gastrointestinal flatulence (P = 0.028) and bowel habits (P = 0.018) at the 8th week. Alpha diversity analysis of the gut microbiota suggested that the Shannon index was significantly higher in the Combined group than in the Placebo group (3.33±0.66 vs. 2.94±0.77, P=0.040). The difference in beta diversity of the gut microbiota was statistically significant between the two groups (P<0.05). The abundance of Clostridia, Clostridium butyricum, Prevotella, Pseudomonas and Lactobacillus was significantly higher in group C compared to group P (P<0.05).
Conclusions: In IBS-D patients, Clostridium butyricum capsule combined with inulin-based probiotic significantly improved patient prognosis, possibly related to the fact that the combination therapy altered the patient's gut microbiota.
Keywords: Irritable Bowel Syndrome; Randomized ControlledTrial; Clostridium Butyricum; Probiotics; Gut Microbiota
