Efficacy and Safety of a Novel Oral Rehydration Solution (ORS) in Managing Diarrhea and Dehydration: A Randomized Study in Indian Patients.

BACKGROUND: Acute diarrhea is a leading cause of dehydration-related morbidity. Oral rehydration solution (ORS) remains the cornerstone of treatment, while probiotics have shown additional gut health benefits. This study evaluated the efficacy and safety of a novel probiotic-enriched ORS compared with a standard ORS in Indian patients with acute diarrhea. METHODS: In this randomized, parallel-group study, patients with diarrhea were enrolled and assigned to receive either novel ORS or traditional ORS. Treatment was administered for five days, followed by a four-day observation period and a safety follow-up call. Group 1 received the novel ORS (200 mL/day) for five days, and Group 2 received traditional ORS (200 mL/day) for a similar duration. Efficacy outcomes measured included resolution of diarrhea, time to recovery, patient-reported satisfaction and preference, and Clinical Global Impression-Improvement (CGI-I) score. RESULTS: In this randomized, parallel-group study, 60 patients with diarrhea were enrolled and assigned (3:1) to receive either novel ORS (n = 45) or traditional ORS (n = 15). Both groups showed clinical improvement; however, the novel ORS group demonstrated faster resolution. By visit 3, the mean diarrhea episodes were 0.4 (0.62) in the novel ORS group, while 0.9 (0.86) in the traditional group. Higher satisfaction was reported in the novel ORS group (42.2% "very satisfied") along with quicker improvement on the CGI-I score (mean score 1.3 vs. 1.9; p = 0.0120). CONCLUSION: The novel ORS containing probiotics showed faster symptom resolution, higher patient satisfaction, and comparable safety, supporting its potential as a preferred treatment option for diarrhea management.