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NCT ID: NCT06308848 Not yet recruiting - Clinical trials for Severe Acute Malnutrition

Microbiota Directed Food for Children With Severe Acute Malnutrition

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.

NCT ID: NCT06305442 Not yet recruiting - Clinical trials for Moderate Acute Malnutrition

Microbiota Directed Food for Children With Moderate Acute Malnutrition

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food.we propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF.

NCT ID: NCT06295250 Not yet recruiting - Depression Clinical Trials

ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question[s] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months.

NCT ID: NCT06137664 Not yet recruiting - Poliomyelitis Clinical Trials

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Start date: December 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The main objectives of this study are to : - evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; - evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. - compare type-specific antibody responses among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; - evaluate the type-specific and overall antibody response among healthy neonates following 4 doses of combined nOPV1+nOPV2.

NCT ID: NCT06129253 Not yet recruiting - HPV Infection Clinical Trials

Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

HPV
Start date: November 2023
Phase:
Study type: Observational

This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.

NCT ID: NCT06068530 Not yet recruiting - Clinical trials for Plasmodium Falciparum Malaria

Mass Vaccine and Drug Administration, Bangladesh

MVDA
Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.

NCT ID: NCT06045104 Not yet recruiting - Clinical trials for Moderate Acute Malnutrition

Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months With Moderate Acute Malnutrition in Bangladesh.

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

In spite of the large burden of acute malnutrition in the country, the Community-based Management of Acute Malnutrition (CMAM) protocol approved in Bangladesh highly deviates from the WHO normative guidance, in that it does not support the use of any currently existing nutritional products for Moderate Acute Malnutrition (MAM) cases: it relies solely on nutrition counselling. On another hand, some non-governmental organizations (NGOs) are implementing programs making a standard use of specialized nutritional products, such as nutritional supplements like Wheat Soy Blend (WSB)++ to manage MAM cases, in children of Forcibly Displaced Myanmar Nationals (FDMNs) in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well. The "no-food" CMAM policy for MAM is decreasing the cost of treatment, yet this may undermine effectiveness and impact. In this context, policy makers need evidence regarding context specific, effective and scalable interventions for CMAM. This cluster randomized control trial (cRCT) will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Cox's Bazar district of Bangladesh among children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months (120 days). Then followed up for 6 months (180 days) post treatment completion. Each arm will consist of 280 children with MAM. Both the arms will receive nutrition counselling along with the study intervention, as follows: In the first arm, the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisis/emergency settings and widely used internationally: children with MAM will receive WSB++ with nutrition counselling for a period of 4 months (120 days),. In the second arm, children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months (120 days). A cluster sampling technique will be used to enroll participants. Each Community Clinic and Union Health & Family Welfare Centers will serve as unit of cluster for the randomization. Primary outcome variables are: 1) Daily weight gain (g/kg/d) between enrolment and end of the treatment period. 2) Recovery rate (%) at the end of the treatment period.

NCT ID: NCT05987488 Not yet recruiting - Healthy Volunteers Clinical Trials

ShigETEC Vaccine Study in Bangladesh

Start date: September 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months). The main question[s] it aims to answer are: - Safety and clinical tolerability of the vaccine - Immune responses generated by the vaccine In the age-descending dose-escalating study - Adult participants will be divided into 2 escalating dose cohorts - Each age group of paediatric participants will be divided into 3 escalating dose cohorts - Participants in each cohort will receive three doses of vaccine/placebo two weeks apart - Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be monitored after each vaccination dose - Stool samples will be collected for immunological analysis and shedding of vaccine strain - Blood samples will be collected for immunological analysis

NCT ID: NCT05872412 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

In this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. This study will help us identify which option is the most effective and safe.

NCT ID: NCT05855551 Not yet recruiting - Clinical trials for Gestational Weight Gain

Improving Birth Outcomes in Bangladesh

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh. Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant. A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.