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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are studying how exposure to high environmental temperatures during pregnancy affects the health of pregnant women and their babies in rural Sindh, Pakistan. The study aims to understand how heat stress impacts pregnancy complications and birth outcomes like early birth or low birth weight. It also explores biological pathways through which heat affects maternal, fetal, and infant health, considering factors such as socio-demographics and nutrition. This observational study enrolls pregnant women in their first trimester under 14 weeks and follows them through pregnancy and up to 12 months after birth. Participants wear devices measuring temperature and humidity, and some wear additional sensors to track skin temperature, heart rate, physical activity, and sleep. Researchers perform ultrasounds, collect blood and urine samples, and use questionnaires about heat exposure and coping strategies. After delivery, data on newborn size, birth timing, and complications are collected, along with placental and breastmilk samples for a subset. During the study, women attend clinic visits in the second and third trimesters for ongoing assessments. Researchers monitor heat exposure, physiological stress, hydration, and pregnancy progress through repeated ultrasounds and lab tests. The mother-infant pairs are followed monthly for a year to track health, growth, feeding, immunization, and development. The primary outcomes include low birth weight and small vulnerable newborns, with safety monitored throughout. This research will help inform protections for pregnant women and infants against climate-related heat risks in low-resource settings.

Age: 18Years +FEMALE
3 locations
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Actively Recruiting

Researchers are evaluating the safety and nutritional adequacy of a Goat Milk-Derived Formula Alternative GMDFA for infants aged 8 to 10 weeks who cannot be exclusively breastfed. The study compares growth, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk. The goal is to see if GMDFA supports similar growth patterns and gut health as breastfeeding, especially in low-resource settings with malnutrition concerns. Participants are randomly assigned to one of three groups those fed GMDFA made to a standardized recipe for 8 weeks, those fed undiluted goat milk following local practices for 8 weeks, and a reference group of exclusively breastfed infants. The study carefully monitors infant growth and collects samples of blood, stool, and breast milk where applicable to analyze microbiome diversity, metabolic pathways, and lipid profiles. During the study, infants will have regular follow-up visits for growth measurements and biological sample collection. Feeding practices will be tracked through caregiver interviews and feeding logs. Researchers will measure changes in lipidomic markers and gut microbiome composition from baseline to 8 weeks after intervention, as well as growth by weight-for-age z-score up to 16-18 weeks of age. Safety and nutritional biomarkers will also be assessed to ensure the feeding options are appropriate.

Age: 8Weeks - 10WeeksAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Environmental Enteric Dysfunction EED is a gut condition that affects many children, leading to malnutrition, poor brain development, stunted growth, vaccine failure, and infections. This trial studies pregnant women to see if a probiotic treatment can improve gut health by reducing harmful bacteria and inflammation. The research focuses on whether giving an antibiotic followed by a probiotic can reduce certain bacterial pathogens in pregnant women colonized by these bacteria. The study enrolls 144 pregnant women in their second trimester from communities in Pakistan and other countries. Participants will be randomly assigned to three groups one receiving oral vancomycin antibiotic followed by the probiotic VE818, another receiving vancomycin followed by a placebo, and an observation-only group with no intervention. Vancomycin will be given three times daily for 5 days, followed by a 1-day break, then daily probiotic or placebo for 14 days. The study is double-blinded and involves careful monitoring throughout pregnancy. Participants will undergo various tests including blood, urine, stool, saliva, and vaginal swabs collected before, during, and after treatment. A special non-invasive capsule called CapScan will collect gut samples. Researchers will measure changes in harmful bacteria counts using advanced lab techniques, track pregnancy progress with ultrasounds, and follow mothers and babies up to one month after birth. Daily visits will monitor adherence and any side effects, ensuring detailed data collection during the study period.

Age: 18Years - 49YearsFEMALEPhase 2
1 location
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Actively Recruiting

Healthy Volunteer

This research aims to evaluate whether simple and affordable interventions can protect health and improve quality of life during extreme heat in rural, low-income villages of Matiari, Pakistan. It focuses on reducing heat-related health problems like dizziness, headaches, and heatstroke, while also improving indoor temperatures, sleep quality, comfort, and daily functioning. The study compares communities receiving heat-related support and information with those that do not, to identify effective strategies for vulnerable populations. Participants in the study will be divided into two groups one receiving the Resilience and Heat Adaptation Bundle ReHAB, which includes community education and awareness through local groups, as well as structural home modifications such as reflective roof paint, shading, improved ventilation, and solar panels. The control group will not receive these interventions. The study involves community mobilization, education sessions, and shared-cost improvements to homes to lower indoor heat exposure. During the study, participants will answer questions about their health and living conditions and have temperature sensors installed in their homes. Some may wear wristbands to monitor sleep and heart rate. Researchers will track heat-related illnesses, quality of life, indoor heat levels, hospital visits, mortality, and thermal comfort over 24 months. Blood samples will be collected at the end for biobanking. The study lasts approximately two years to assess the long-term effects of these heat adaptation interventions.

All GendersPhase Not Applicable
1 location