Background and Objective

Acute diarrhea remains a critical challenge in pediatrics, especially in developing countries. This randomized controlled feasibility trial (RCT) was conducted to assess the practicability of a full-scale study and to obtain pilot data on the efficacy of polymethylsiloxane polyhydrate as an adjunct to standard treatment (oral rehydration fluid and zinc) in children aged 6–59 months in The Gambia.

Key Findings

The study, involving 50 children, confirmed the high feasibility of conducting an RCT in this region.

Clinical Outcomes:

Diarrhea Duration (Primary Endpoint): The intervention group recorded a reduction in the mean time to the last watery stool by 19.3 hours (95% CI: -30.9 to -7.8 hours; p=0.0016).

Stool Frequency: A statistically significant reduction in daily stool frequency by 0.8 stools per day was noted on days 2 and 3 of treatment (p=0.0022 and p=0.0014, respectively).

Adherence to ORF: Increased consumption of oral rehydration fluid was observed in the adsorbent group, representing a crucial finding for clinical practice.

Safety: The therapy was well tolerated. No adverse events related to polymethylsiloxane polyhydrate were reported.

Implications for Practice

The resulting pilot data convincingly demonstrate the potential of polymethylsiloxane polyhydrate for a significant reduction in the duration and severity of acute diarrhea. The successful completion of this phase justifies the necessity and informs the design of a subsequent large-scale, multicenter RCT to confirm efficacy and the potential integration of this adjuvant agent into international clinical guidelines.

For detailed methodology, demographic and laboratory analysis, and full statistical data, please refer to the complete article.

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