Pathways of antibiotic use in Bangladesh: qualitative protocol for the PAUSE study.

INTRODUCTION: Global actions to reduce antimicrobial resistance (AMR) include optimising the use of antimicrobial medicines in human and animal health. In countries with weak healthcare regulation, this requires a greater understanding of the drivers of antibiotic use from the perspective of providers and consumers. In Bangladesh, there is limited research on household decision-making and healthcare seeking in relation to antibiotic use and consumption for humans and livestock. Knowledge is similarly lacking on factors influencing the supply and demand for antibiotics among qualified and unqualified healthcare providers.The aim of this study is to conduct integrated research on household decision-making for healthcare and antibiotic use, as well as the awareness, behaviours and priorities of healthcare providers and sellers of antibiotics to translate into policy development and implementation. METHODS AND ANALYSIS: In-depth interviews will be conducted with (1) household members responsible for decision-making about illness and antibiotic use for family and livestock; (2) qualified and unqualified private and government healthcare providers in human and animal medicine and (3) stakeholders and policy-makers as key informants on the development and implementation of policy around AMR. Participant observation within retail drug shops will also be carried out. Qualitative methods will include a thematic framework analysis.A holistic approach to understanding who makes decisions on the sale and use of antibiotics, and what drives healthcare seeking in Bangladesh will enable identification of routes to behavioural change and the development of effective interventions to reduce the health risks of AMR. ETHICS AND DISSEMINATION: Approval for the study has been obtained from the Institutional Review Board at the International Centre for Diarrhoeal Disease Research, Bangladesh following review by the Research and Ethics Committees (PR-16100) and from Loughborough University (R17-P081). Information about the study will be provided in a participant information letter in Bangla (to be read verbally and given in writing to participants). A written informed consent form in Bangla will be obtained and participants will be informed of their right to withdraw from the study. Dissemination will take place through a 1 day dissemination workshop with key stakeholders in public health and policy, practitioners and scientists in Bangladesh, and through international conference presentations and peer-review publications. Anonymised transcripts of interviews will be made available through open access via institutional data repositories after an embargo period.

Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh.

Background: Anemia in young children is a global health problem. Risk factors include poor nutrient intake and poor water quality, sanitation, or hygiene. Objective: We evaluated the effects of water quality, sanitation, handwashing, and nutrition interventions on micronutrient status and anemia among children in rural Kenya and Bangladesh. Design: We nested substudies within 2 cluster-randomized controlled trials enrolling pregnant women and following their children for 2 y. These substudies included 4 groups: water, sanitation, and handwashing (WSH); nutrition (N), including lipid-based nutrient supplements (LNSs; ages 6-24 mo) and infant and young child feeding (IYCF) counseling; WSH+N; and control. Hemoglobin and micronutrient biomarkers were measured after 2 y of intervention and compared between groups using generalized linear models with robust SEs. Results: In Kenya, 699 children were assessed at a mean ± SD age of 22.1 ± 1.8 mo, and in Bangladesh 1470 participants were measured at a mean ± SD age of 28.0 ± 1.9 mo. The control group anemia prevalences were 48.8% in Kenya and 17.4% in Bangladesh. There was a lower prevalence of anemia in the 2 N intervention groups in both Kenya [N: 36.2%; prevalence ratio (PR): 0.74; 95% CI: 0.58, 0.94; WSH+N: 27.3%; PR: 0.56; 95% CI: 0.42, 0.75] and Bangladesh (N: 8.7%; PR: 0.50; 95% CI: 0.32, 0.78; WSH+N: 7.9%, PR: 0.46; 95% CI: 0.29, 0.73). In both trials, the 2 N groups also had significantly lower prevalences of iron deficiency, iron deficiency anemia, and low vitamin B-12 and, in Kenya, a lower prevalence of folate and vitamin A deficiencies. In Bangladesh, the WSH group had a lower prevalence of anemia (12.8%; PR: 0.74; 95% CI: 0.54, 1.00) than the control group, whereas in Kenya, the WSH+N group had a lower prevalence of anemia than did the N group (PR: 0.75; 95% CI: 0.53, 1.07), but this was not significant (P = 0.102). Conclusions: IYCF counseling with LNSs reduced the risks of anemia, iron deficiency, and low vitamin B-12. Effects on folate and vitamin A varied between studies. Improvements in WSH also reduced the risk of anemia in Bangladesh but did not provide added benefit over the nutrition-specific intervention. These trials were registered at clinicaltrials.gov as NCT01590095 (Bangladesh) and NCT01704105 (Kenya).

Spatial and temporal variation in the community prevalence of antibiotic resistance in Bangladesh: an integrated surveillance study protocol.

INTRODUCTION: Increasing antibiotic resistance (ABR) in low-income and middle-income countries such as Bangladesh presents a major health threat. However, assessing the scale of the health risk is problematic in the absence of reliable data on the community prevalence of antibiotic-resistant bacteria. We describe the protocol for a small-scale integrated surveillance programme that aims to quantify the prevalence of colonisation with antibiotic-resistant bacteria and concentrations of antibiotic-resistant genes from a 'One Health' perspective. The holistic assessment of ABR in humans, animals and within the environment in urban and rural Bangladesh will generate comprehensive data to inform human health risk. METHODS AND ANALYSIS: The study design focuses on three exposure-relevant sites where there is enhanced potential for transmission of ABR between humans, animals and the environment: (1) rural poultry-owning households, (2) commercial poultry farms and (3) urban live-bird markets. The comparison of ABR prevalence in human groups with high and low exposure to farming and poultry will enable us to test the hypothesis that ABR bacteria and genes from the environment and food-producing animals are potential sources of transmission to humans. Escherichia coli is used as an ABR indicator organism due to its widespread environmental presence and colonisation in both the human and animal gastrointestinal tract. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of the International Centre for Diarrhoeal Disease Research, Bangladesh, and Loughborough University Ethics Committee. Data for the project will be stored on the open access repository of the Centre for Ecology and Hydrology, Natural Environment Research Council. The results of this study will be published in peer-reviewed journals and presented at national and international conferences.

Impact of adding hand-washing and water disinfection promotion to oral cholera vaccination on diarrhoea-associated hospitalization in Dhaka, Bangladesh: evidence from a cluster randomized control trial.

Background: Information on the impact of hygiene interventions on severe outcomes is limited. As a pre-specified secondary outcome of a cluster-randomized controlled trial among >400 000 low-income residents in Dhaka, Bangladesh, we examined the impact of cholera vaccination plus a behaviour change intervention on diarrhoea-associated hospitalization. Methods: Ninety neighbourhood clusters were randomly allocated into three areas: cholera-vaccine-only; vaccine-plus-behaviour-change (promotion of hand-washing with soap plus drinking water chlorination); and control. Study follow-up continued for 2 years after intervention began. We calculated cluster-adjusted diarrhoea-associated hospitalization rates using data we collected from nearby hospitals, and 6-monthly census data of all trial households. Results: A total of 429 995 people contributed 500 700 person-years of data (average follow-up 1.13 years). Vaccine coverage was 58% at the start of analysis but continued to drop due to population migration. In the vaccine-plus-behaviour-change area, water plus soap was present at 45% of hand-washing stations; 4% of households had detectable chlorine in stored drinking water. Hospitalization rates were similar across the study areas [events/1000 person-years, 95% confidence interval (CI), cholera-vaccine-only: 9.4 (95% CI: 8.3-10.6); vaccine-plus-behaviour-change: 9.6 (95% CI: 8.3-11.1); control: 9.7 (95% CI: 8.3-11.6)]. Cholera cases accounted for 7% of total number of diarrhoea-associated hospitalizations. Conclusions: Neither cholera vaccination alone nor cholera vaccination combined with behaviour-change intervention efforts measurably reduced diarrhoea-associated hospitalization in this highly mobile population, during a time when cholera accounted for a small fraction of diarrhoea episodes. Affordable community-level interventions that prevent infection from multiple pathogens by reliably separating faeces from the environment, food and water, with minimal behavioural demands on impoverished communities, remain an important area for research.

Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial.

BACKGROUND: Probiotics have rarely been studied in young healthy infants from low-income countries. This phase I study investigated the safety and acceptability of two probiotics in Bangladesh. METHODS: Healthy infants aged four to twelve weeks from urban slums in Bangladesh were randomized to one of three different intervention dosing arms (daily, weekly, biweekly - once every two weeks) of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 over one month or to a fourth arm that received no probiotics. All subjects were followed for two additional months. Reported gastrointestinal and respiratory symptoms as well as breastfeeding rates, hospitalizations, differential withdrawals, and caretakers' perception of probiotic use were compared among arms. RESULTS: In total, 160 infants were randomized (40 to each arm) with 137 (Daily n = 35, Weekly n = 35, Biweekly n = 35, Control n = 32) followed up for a median of twelve weeks; 113 completed the study. Illness and breastfeeding rates were similar across all arms. Ten hospitalizations unrelated to probiotic use occurred. Forty eight percent of the caretakers of infants in intervention arms believed that probiotics improved their baby's health. CONCLUSIONS: These two commonly used probiotics appeared safe and well-accepted by Bangladeshi families. TRIAL REGISTRATION: ClinicalTrials.gov NCT01899378 . Registered July 10, 2013.