Evaluation of Streptococcus faecalis, Clostridium butyricum, Bacillus mesentericus, Lactobacillus sporogenes, Saccharomyces Boulardi multistrain probiotic formulation in acute gastroenteritis: a real-world observational study (MAESTRO)

Abstract

Background

Gastroenteritis is a leading cause of global morbidity, characterized by inflammation of the stomach, small intestine, or large intestine, resulting in diarrhea, vomiting, and abdominal pain. Acute gastroenteritis (AGE) typically resolves within 14 days, but probiotics are increasingly used to restore gut microbiota balance and counteract pathogenic organisms. This study evaluates the safety and efficacy of a novel multistrain probiotic formulation in managing AGE and antibiotic-associated diarrhea (AAD).

Methods

This observational, real-world study included 683 patients from 239 sites across India, assessing the effects of a multistrain probiotic formulation in AGE and AAD. The study adhered to ICH-GCP guidelines and the Declaration of Helsinki, with Ethics Committee approval. Clinical outcomes were assessed based on stool frequency, consistency, and Clinician’s Global Impression of Improvement (CGI-I) scores after 7 days of treatment. Statistical analyses were conducted using SPSS version 29.0.1.0 to evaluate significant changes in these parameters.

Results

Among AGE patients (mean age: 45.91 ± 11.77 years; 68.92% male), 56.42% had no comorbidities. The most common symptoms were diarrhea (96.70%) and abdominal cramps (37.67%). Probiotics were prescribed to 93.92% of patients, with 93.23% achieving diarrhea resolution. Stool frequency significantly declined from 5.63 ± 1.43 to 1.65 ± 0.65 per day (68.94% reduction, p < 0.0001), and 95.31% of patients achieved normal stool consistency. CGI-I scores improved in 99.83% of cases. Among AAD patients (mean age: 43.32 ± 11.64 years; 60.75% male), diarrhea (97.20%) and vomiting (30.84%) were predominant symptoms. Probiotics were prescribed to 99.07% of patients, with an equal proportion achieving diarrhea resolution. Stool frequency significantly decreased by 67.94% (p < 0.0001), and Oral Rehydration Solution (ORS) use declined from 54.21% at baseline to zero by Day 7. No treatment-related adverse events were reported.

Conclusion

The multistrain probiotic formulation significantly improved stool frequency and consistency in AGE and AAD patients within 7 days. Additionally, it effectively reduced ORS dependence and exhibited a strong safety profile, with no reported adverse events. These findings support the probiotic’s potential as a safe and effective adjunct in managing AGE and AAD.

Trial registration

This clinical study was registered at CTRI (Clinical Trial Registry of India) under the Registered number CTRI/2024/01/061546 on 17 Jan 2024.