An Open Label Clinical Study to Evaluate the Safety and Gastrointestinal Tolerance of ONS in Hospitalized Patients Requiring Enteral Tube Feeding

Author(s):

Chetan Mehndiratta* and Yogendra Kumar

Background: The present study aimed to investigate the compliance of the Oral Nutritional Supplement (ONS) in enteral feeding protocol on the basis of GI Tolerance and improvement in patient outcomes, including safety parameters. Design: It is a 1 month, prospective, open label, investigatorinitiated study conducted between 6 Jan 2020 to 31 January 2021. Methodology: Participants of either sex, aged ≥ 18 years, hospitalized for minimum two days, requiring enteral feeding were given two feeds of ONS (45 gm diluted in 100 mL of water) along with four standard kitchen feeds at different timings. Primary endpoint was to monitor continuous GI and stomach tolerance and effect o n G astric R esidual Volume (GRV). Secondary endpoints were change in BMI, Serum albumin levels, and adverse events monitoring. Data was analyzed descriptively using paired ttest and p value of <0.05 was considered statistically significant. Results: Fifteen (12 males, 3 females, mean age: 46.3 ± 8.9 years) participants were enrolled. None of participants reported gastric intolerance. Continuous GI tolerance presented patient compliance for the ONS with Gastric Residual Volume (GRV) within the limits (<500 ml) for all participants. Significant gradual improvement in BMI (p<0.0001) and serum albumin levels (p=0.0001) were reported in hospital when fed with ONS supplement administered with hospital kitchen feed. Conclusion: Results of current study suggest that ONS is safe and tolerable product for patients requiring enteral feeding, however larger clinical studies (with statistically significant sample size) can be planned to see broader aspects of enteral feeding.