# Prevention of Clostridium Difficile Infection Among Hospitalized Elderly Patients Using Torani (Fermented Rice Water) and Xylitol Mixture Drink: The Study Protocol of an Open-Label Randomized Controlled Trial

## TL;DR

This study tests if a fermented rice water and xylitol drink can prevent Clostridium difficile infection in elderly hospitalized patients.

## Contribution

The novel approach combines traditional fermented food (Torani) with prebiotics (xylitol) to prevent CDI in elderly patients.

## Key findings

- The study will assess the effect of Torani-xylitol mixture on CDI prevention in hospitalized elderly.
- If effective, the mixture could reduce CDI-related hospitalization and costs.

## Abstract

Background and objectives: Clostridium difficile infections (CDI) among elderly individuals are common. Antibiotic use and gut dysbiosis are major contributors to CDI. Probiotics and prebiotics help prevent CDI by addressing dysbiosis. This study aims to document the effect of the combination of probiotics from Torani, a traditional fermented food (rich in Lactobacillus species), and prebiotics (xylitol) on CDI among elderly hospitalized individuals.

Methods: This two-arm, open-label, randomized controlled trial (RCT) will be conducted at a tertiary care hospital in Odisha, India. The eligible elderly hospitalized participants will be randomized into two groups in a 1:1 ratio to receive 350 ml of either Torani-xylitol mixture or plain water once daily for 14 days. The data on sociodemography, clinical, and laboratory tests, antibiotics, and other medications used shall be recorded from their case sheets. Stool samples or rectal swabs will be collected on days 0 and 15 or at discharge/death/referral for CD isolation. A stool or rectal swab sample will be collected for any suspected CDI during the hospitalization. Follow-up contacts will be made on days 30 (+7), 60 (+7), and 90 (+7) to address any illness/infection, medication use, hospitalization, blood tests, and dietary practices.

Results: As we have not started the study, we do not have any observations yet.

Conclusions: This RCT shall document the effect of the Torani-xylitol mixture on CDI prevention and CD colonization among hospitalized elderly individuals. If found effective, it can promote using beneficial fermented foods to prevent CDI, reducing morbidity, mortality, hospitalization rate, and duration, cost of therapy, and bed occupancy.