Green Banana Mixed Diet is Beneficial in the Management of Childhood Persistent Diarrhea: An Open, Randomized-Controlled Trial

2021 ◽  
Author(s):  
Monira Sarmin ◽  
Md Iqbal Hossain ◽  
Shoeb Bin Islam ◽  
Shamima Sharmin Shikha ◽  
Md Nur Haque Alam ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mixed Diet ◽  
Persistent Diarrhea ◽  
Randomized Controlled ◽  
Green Banana

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

2021 ◽  
Author(s):  
Md Iqbal Hossain ◽  
Monira Sarmin ◽  
Shoeb Bin Islam ◽  
Shamima Sharmin Shikha ◽  
Md Nur Haque Alam ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Causal Link ◽  
Persistent Diarrhea ◽  
Death Studies ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Wide Range ◽  
Taqman Array ◽  
Green Banana

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

Efficacy of Milk-based Diets in Persistent Diarrhea: A Randomized, Controlled Trial

PEDIATRICS ◽  
1996 ◽  
Vol 98 (6) ◽  
pp. 1122-1126
Author(s):  
Shinjini Bhatnagar ◽  
Maharaj K. Bhan ◽  
Kiran D. Singh ◽  
Shailendra K. Saxena ◽  
Malini Shariff
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Controlled Trial ◽  
Egg White ◽  
Mixed Diet ◽  
Persistent Diarrhea ◽  
Randomized Controlled ◽  
Puffed Rice ◽  
Baseline Characteristics ◽  
Cereal Group

Objective. Previous studies have shown increased stool output when children with persistent diarrhea (PD) received milk as the predominant source of nutrition. Methods. We evaluated the efficacy of milk given in modest amounts as a part of a mixed diet in children with PD. One hundred sixteen children 3 to 24 months of age with diarrhea for between 14 days and 12 weeks were allocated to milk-based (n = 60) or milk-free (n = 56) cereal dietary regimens. The two diets were isocaloric (86.9 calories/100 g for ≤9 months; 95.6 cal/100 g for > 9 months) consisting of puffed rice cereal, sugar, and oil differing in only their source of protein, which was either milk or egg white, respectively. An average of 30% of the calories were constituted by milk in the milk-cereal diet. Both diets were offered at the rate of 150 kcal/kg per day. Children receiving milk-cereal consumed an average of 1.9 g/kg lactose per day. Results. The baseline characteristics in the two groups were similar. Comparable amounts of diet were consumed in both groups. The milk-cereal group did not have higher median (range) stool output (g/kg/h) compared with the milk-free group during a 0- to 48-hour (milk-cereal, 1.7 [0.2 to 8.7]; milk-free, 1.5 [0.1 to 6.6]) or 0- to 120-hour (milk-cereal, 1.6 [0.4 to 7.2]; milk-free, 1.3 [0.1 to 7.6]) period. The percentage of weight gain was similar in the two groups, and there were no significant differences in the duration of diarrhea. Overall, 23 children had treatment failures, 10 (17%) in the milk-cereal and 13 (23.6%) in the milk-free groups. Conclusions. Our findings suggest that modest intakes of milk are well tolerated as a part of mixed diet during PD.

scholarly journals Efficacy of a Green Banana–Mixed Diet in the Management of Persistent Diarrhea: Protocol for an Open-Labeled, Randomized Controlled Trial

10.2196/15759 ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. e15759 ◽  
Author(s):  
Monira Sarmin ◽  
Md Iqbal Hossain ◽  
Shoeb Bin Islam ◽  
Nur Haque Alam ◽  
Shafiqul Alam Sarker ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hospital Costs ◽  
Case Fatality ◽  
Public Health Problem ◽  
Controlled Study ◽  
Persistent Diarrhea ◽  
Important Public Health Problem ◽  
Randomized Controlled ◽  
Full Strength ◽  
Green Banana

Background Diarrhea is the second-leading cause of death in children under 5 years of age. In low- and middle-income countries, 3%-20% of acute diarrheal episodes become persistent diarrhea (PD) (ie, duration ≥14 days), which results in 36%-56% of all diarrheal deaths. In Bangladesh, PD causes >25% of diarrhea-related deaths. Commensal gut microbiota dysbiosis is increasingly recognized in the pathogenesis of PD. Hospital-based management of PD requires a hospital stay, which increases the risk of infection and hospital costs. The higher cost of treatment and high case-fatality rates reiterate PD as an important public health problem. At the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), for the last two decades, a consensus-based guideline has been followed for PD. Observation has revealed that green banana helps in the resolution of diarrhea. However, no larger prospective study has been conducted to evaluate the efficacy of green banana in the management of PD among children older than 6 months of age. Objective Our objective is to assess the efficacy of full-strength rice suji with and without green banana compared to three-quarter-strength rice suji in the management of PD in children aged 6-36 months at the Dhaka Hospital of the icddr,b. Methods This open-labeled, randomized controlled study aims to enroll a total of 145 children with PD who have not been improving on a diet of milk suji. Children will be randomized into three different diet-specific groups: full-strength rice suji containing green banana, full-strength rice suji alone, and three-quarter-strength rice suji. The primary outcome is the percentage of children who recovered from diarrhea by day 5. Results Recruitment and data collection began in December 2017 and were completed in November 2019. Results are expected by April 2020. Conclusions This study is expected to provide insights into the incorporation of green banana into the dietary management of PD. This would be the first study to investigate the role of microbiota and metabolomics in the pathogenesis of PD. Trial Registration ClinicalTrials.gov NCT03366740; https://clinicaltrials.gov/ct2/show/NCT03366740 International Registered Report Identifier (IRRID) DERR1-10.2196/15759

Effect of Green Banana (Musa paradisiaca) on Recovery in Children With Acute Watery Diarrhea With No Dehydration: A Randomized Controlled Trial

2020 ◽  
Vol 57 (12) ◽  
pp. 1114-1118 ◽  
Author(s):  
Dhandapany Gunasekaran ◽  
Anandhi Chandramohan ◽  
Kadirvel Karthikeyan ◽  
Banupriya Balasubramaniam ◽  
Podhini Jagadeesan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Watery Diarrhea ◽  
Musa Paradisiaca ◽  
Randomized Controlled ◽  
Acute Watery Diarrhea ◽  
Green Banana

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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