Green Banana mixed Diet is Beneficial in the Management of Childhood Persistent Diarrhea: an Open, Randomized-Controlled Trial (Preprint)

BACKGROUND Persistent diarrhea (PD), diarrhea for ≥14 days, accounts for 36%-56% of all diarrhea-related death. Studies demonstrated that green banana helps in the resolution of diarrhea. OBJECTIVE We assessed whether a lactose-free diet rice suji (RS) or rice suji containing green banana (GB-RS), improves outcome compared with 3/4th strength rice suji (3/4th RS) in 6 to 35 months old children having PD in the icddr,b Dhaka hospital. METHODS In this open-labeled, randomized, controlled trial, children with PD not improving with milk suji (the initial diet) received any of the three study diets: GB-RS, RS, 3/4th RS. The primary outcome was the percentage of children who recovered from diarrhea by day 5 with an intention to treat analysis. RESULTS From 1st December 2017 to 31st August 2019, we randomly allocated 45 children to each group. By day 5, 66 children recovered from PD, of whom 26 (58%), 14 (31%), 26 (58%) received GB-RS, RS, and 3/4th RS respectively. Significantly more resolution of PD occurred in GB-RS and 3/4th RS groups compared to RS group [relative risk (RR) 1⸱71, 95% CI 1⸱19-2⸱60; p=0⸱019]. Two (10%) children died, one each in RS group and GB-RS group. TaqMan array card (TAC) identified EAEC, rotavirus, norovirus, EPEC, astrovirus, and Campylobacter as the major pathogens associated with PD. CONCLUSIONS GB-RS and 3/4th RS are efficacious in the management of PD in young children. We also demonstrated a wide range of entero-pathogen associated with PD by TAC which needs further study to find a causal link. CLINICALTRIAL ClinicalTrials.gov, ID: NCT03366740 Registered on 8th December 2017 INTERNATIONAL REGISTERED REPORT RR2-10.2196/15759