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NCT ID: NCT03666572 Not yet recruiting - Clinical trials for Severe Acute Malnutrition

Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition

Start date: September 15, 2018
Phase: Phase 2
Study type: Interventional

Malnutrition is an ever-present problem worldwide. It is estimated that over 18 million children under the age of 5 are affected by the most extreme form of under nutrition, severe acute malnutrition (SAM). Inspite of having standardized management protocols, in many hospitals inpatient mortality reaches up to 30%. Infectious morbidity is common among survivors. Diarrhea, severe intestinal inflammation, low concentrations of fecal short chain fatty acids (SCFAs), and severe systemic inflammation are significantly associated with mortality in SAM. Investigators of this study have earlier shown that the gut microbiota in children with SAM is immature and is causally related with SAM. Human milk contains between 10 and 20 g/liter of oligosaccharides (human milk oligosaccharides-HMOs) which is the third most abundant solid component after lactose and lipids. HMOs are resistant to gastrointestinal digestion in host infants, and thus the greater part of HMOs reached the colon and may act as prebiotics to shape a healthy gut ecosystem by stimulating the growth of useful microorganisms by acting as receptor analogues to inhibit the binding of various pathogens and toxins to epithelial cells. Probiotics are live organisms beneficial for healthy life. The human digestive tract possesses a diverse microbial community throughout its extent, which support their hosts generally for healthy living. Bifidobacterium spp. is dominant microbiota in infants who are exclusively breastfed and these infants are less likely to suffer from diarrhea. According to recent studies among the most common probiotics genera Lactobacillus and Bifidobacterium, the latter is more abundant in the gut. To carry out their functional activities, Bifidobacteria must be able to survive the gastrointestinal tract transit and persist, at least transiently, in the host. The population of Bifidobacteria in the gut community drastically decreases after weaning. Certain Bifidobacteria possess the metabolic capabilities to break down the HMOs. Consequently it is observed that HMOs support the growth of select Bifidobacteria in the gut of the infant. Research done at icddr,b and Washington University indicates that gut microbes are related to undernutrition and that children with SAM have gut dysbiosis that mediates some of the pathology of their condition. The standard of care in these children should be reinforced by an intervention that corrects the gut dysbiosis, improves weight gain during nutritional rehabilitation and reduces infectious morbidity. Investigators do not have any published data on the microbiome response to probiotic supplementation (with and without prebiotics) in malnourished infants or preserving the microbiome with probiotics in non-malnourished children. A short-term pilot study should be conducted to evaluate the microbiome response to probiotic supplementation (with and without prebiotics) in malnourished population to justify a larger study of clinical outcomes. Additionally, non-malnourished infants who are hospitalized for infectious conditions face challenges related to gut dysbiosis caused by antibiotic usage. Here the investigators will evaluate the ability of a probiotic intervention to rescue the microbiome of primarily breastfed non-malnourished infants. Intervention: Bifidobacterium longum subspecies infantis (EVC001) with and without prebiotic supplementation for 28 days. Objectives: To evaluate the microbiome response to probiotic supplementation (with and without prebiotics) in infants under 6 months with severe acute malnutrition and to compare the microbiome response with healthy infants with a probiotic. Methods: Single-blind RCT, stratified randomization will be based on infant age at time of transfer to Nutritional Rehabilitation Unit (NRU). 3 treatment arms for infants with SAM 1. Placebo (Lactose) 2. Bifidobacterium infantis alone (Bif) 3. Bifidobacterium infantis + prebiotic Lacto-N-neotetraose [LNnT] (Bif+prebiotic) Age at enrollment 1. 2-3.9 months of age 2. 4-5.9 months of age 1 open-label treatment arm for 18 non-malnourished primarily breastfed infants: Bifidobacterium infantis alone (Bif) Population: 1. Group 1 (SAM): Infants between 2 and <6 months old with SAM as defined by weight-for-length Z score < -3, either sex, caregiver willing to provide consent for enrolment of the infant, caregiver willing to stay in the NRU for about 15 days, residence within 15 km from icddr,b 2. Group 2 (non-malnourished): Non-malnourished infants (WLZ ≥ -1) <6 months old who are hospitalized for treatment with antibiotics for infection, infants receiving at least 50% of nutritional intake from breast milk at the time of hospitalization, either sex, residence within 15 km from icddr,b Primary Outcome measures/variables: Bifidobacterium infantis colonization measured by qPCR during and after supplementation (with and without prebiotics)

NCT ID: NCT03641534 Recruiting - Malaria Clinical Trials

Monitoring of Perfusion in Sepsis and Malaria

PERFuSE
Start date: June 4, 2018
Phase:
Study type: Observational

Sepsis and severe malaria together contribute to an estimated 13 million deaths annually, a great burden of which is in low-income countries. Optimal fluid management is critical yet remains one of the most challenging clinical care elements as volume overload precipitates pulmonary edema and volume restriction may exacerbate acute kidney injury. These complications of sepsis and severe malaria significantly increase mortality, particularly in resource-limited settings lacking mechanical ventilation and renal replacement therapy. Point-of-care ultrasound and passive leg raise testing are two easily implementable, safe and non-invasive clinical bedside fluid assessment tools that could be applied towards developing a fluid management algorithm in low resource settings. Similarly, simple tissue perfusion measures can facilitate understanding of precise indications or contraindication to fluid and vasopressor therapy. However, the performance of these tools has yet to be confirmed in these settings. Accurate assessment of pulmonary tolerance and fluid responsive patients could aid to tailor vasopressor and fluid therapy to the patient condition and disease phase, thus preventing or detecting iatrogenic pulmonary edema and other pulmonary complications. As there is currently limited evidence supporting fluid management recommendations for severe malaria and sepsis in low-resource settings, the potential application of these management tools could optimize supportive therapy and improve outcomes in these populations. The main activity proposed is a prospective, observational study of patients with sepsis and severe malaria to describe the relationship between fluid therapy and vasopressor therapy against measures of tissue perfusion and pulmonary congestion in adult patients with severe malaria or severe sepsis. In addition, the study will assess the performance of simple bedside clinical tools assessing fluid responsiveness, pulmonary congestion and peripheral tissue perfusion. The data from this observational study will facilitate the preparation of a follow-up study to test a clinical algorithm to guide individualized fluid and vasopressor administration.

NCT ID: NCT03641079 Recruiting - Clinical trials for Keratotic Nodular Size

Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease

Start date: September 16, 2017
Phase: Phase 2
Study type: Interventional

Arsenicosis is a major health problem in Bangladesh. Long term exposure of arsenic causes keratosis of palm which reduce working capacity of patient. It also causes invasive skin lesions like Bowen's disease which has a risk to develop squamous cell carcinoma. Brinjal peel is well known for its antioxidant and anticancer properties. So this study will be conducted to identify the compound from brinjal peel extract and to see its outcome on keratosis and Bowen's disease.

NCT ID: NCT03641001 Recruiting - Feeding Behavior Clinical Trials

Nutrition Intervention Integrated With Food Voucher to Improve Child Growth and Feeding Practices

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Brief Summary: Background: The period from birth to two years of age is the "critical window" for the promotion of optimal growth, health, and development. Insufficient quantities and inadequate quality of complementary foods, poor child-feeding practices and high rates of infections have a detrimental impact on growth. Approximately one-third of children less than 5 years of age in developing countries are stunted, and large proportions are also deficient in one or more micronutrients. An estimated 6% or 6 hundred thousand under-5 deaths can be prevented by ensuring optimal complementary feeding (CF) only. Knowledge gap: Even though the importance of CF is established, children < 2y are being fed complementary foods with poor nutrient quality, particularly in resource poor countries like Bangladesh. Relevance: Approximately 36% under 5 children are stunted in Bangladesh. Only 23% of children age 6-23 months is fed appropriately based on recommended infant and young child feeding (IYCF) practices. The routine diet of the population including children is mainly plant based and lacks adequate protein and other essential nutrients. Hygiene is also an issue as only 21% of rural households use soap and water during handwashing. An intervention package including CF counselling, WASH and micronutrient powder (MNP) could be potential option for optimizing complementary feeding practice in rural Bangladesh. Hypothesis: An integrated intervention package will improve child growth in terms of length and complementary feeding practice in the selected intervention area from rural Bangladesh compared to control area. Objectives: 1. To improve nutritional status (length for age Z-score or LAZ) of the children (6-12 mo) through food voucher to promote improved recipe and intervention package with 12 months of intervention period. 2. To improve young child feeding practices following counselling Methods: This will be a community based cluster randomized trial. Group I (intervention) will receive a package of intervention (child feeding counselling, WASH and micronutrient powder) along with food voucher to support feeding their children a homemade snack following a newly developed recipe (suzi firni for <1 year, suzi halua for >1 yr) and Group II (Control) will receive usual health meassages. Baseline and endline survey will be conducted. Growth Monitoring Promotion (GMP) will be done monthly to monitor the growth of the children and utilization of food voucher. Data on child feeding, morbidity and anthropometry (length and weight) will be collected monthly. Outcome measures/variables: 1. Difference in mean LAZ of the children between intervention and control group 2. Difference in mean weight for age Z-score (WAZ) of the children between intervention and control group 3. Difference in proportions of mothers in terms of correct knowledge and practice on CF

NCT ID: NCT03636659 Recruiting - Clinical trials for Visceral Leishmaniasis

Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition

Start date: May 2, 2018
Phase: Phase 1
Study type: Interventional

The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition

NCT ID: NCT03635853 Recruiting - Clinical trials for Improvement of Keratotic Nodular Size

Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis

Start date: September 16, 2017
Phase: Phase 2
Study type: Interventional

Arsenicosis is a massive public health hazard in Bangladesh. Prolonged consumption of water containing high concentration arsenic leads to arsenicosis which is characterized by dermatological features i.e. diffuse melanosis , spotted melanosis and keratosis. Cock's comb is rich in hyaluronic acid, chondroitin sulfate A, B, C and heparin. Hyaluronic acid is a hydrophilic molecules and is a constituent of wound extracellular matrix and facilitate wound healing.This work is aimed to identify the component that is effective in palmar arsenical keratosis.

NCT ID: NCT03632733 Recruiting - Clinical trials for Keratotic Nodular Size

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Start date: January 21, 2018
Phase: Phase 2
Study type: Interventional

It had been found in certain studies that there is an alteration of normal skin flora in patients with arsenical keratosis. The relationship between such altered skin flora and development of keratosis in arsenicosis is not established or explored.There is no such study where effects of antimicrobials have been evaluated as the treatment of arsenical keratosis. So the present study is designed to see the effects of antimicrobials on the altered skin flora (Enterobacter and Aspergillus) in patients with palmar arsenical keratosis.

NCT ID: NCT03627507 Recruiting - Clinical trials for Hepatitis B Infection

Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh.

Start date: July 29, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B is a common and serious infectious disease of the liver, affecting millions of people throughout the world. Persistent Hepatitis B virus infections may cause development of chronic hepatic insufficiency, cirrhosis and hepatocellular carcinoma. Adding to that, Hepatitis B Virus carriers can transmit the disease for many years. It is transmitted through blood or other body fluids infected with the Hepatitis B virus. It is a major cause of morbidity and mortality in countries like Bangladesh. Immunization with Hepatitis B vaccine has been proved effective to prevent HBV infection. But the vaccines, which are recommended till now, are expensive. Locally manufactured Hepatitis B vaccine will be safe, cost effective and affordable for all. The test vaccine will induce similar seroprotection rates to hepatitis B one month post-vaccination and at 7 months, one month after the third dose of vaccine compared to reference vaccine. This will be done by comparing the percentages of participants with ≥10 mIU/ml anti-HBs by vaccinated with either Hepa B or Engerix B vaccine. The non-inferiority margin will be 10%.

NCT ID: NCT03614104 Recruiting - Hypertension Clinical Trials

Awareness Development and Usage of mHealth Technology Among Hypertensive Patients in a Rural Community of Bangladesh

Start date: July 15, 2018
Phase: N/A
Study type: Interventional

To develop awareness, enhance knowledge, attitude and make behavioral changes by using health education and mHealth technology among hypertensive patients in a rural community of Bangladesh, A Randomized Controlled Trial will be conducted in a rural community around Kumudini Women's Medical College and Hospital, Mirzapur, Bangladesh for consecutive12 months and 155 participants will be enrolled over the study periods. Face to face interview will be conducted to develop the awareness among hypertensive individuals as part of provision of improved health care services. The face to face interview will take place at Kumudini Hospital or in the community. Face to face interview will help understanding the individuals' perceptions, attitude, and practices associated with compliance to treatment and behavior change. Additionally, the study will identify major barriers related to hypertension associated health care seeking behaviors. Subjects will be diagnosed cases of hypertension. The selection criteria would be: individuals aged 35 years and more, have at least 1-5 years of schooling, who are open and can exchange their views freely as well as who can be asked in-depth and probing questions. Moreover, specimens will be collected to examine for: serum total cholesterol, random blood sugar, urinary salinity, and urinary protein. Physical measurements like height in meter, weight in kg, MUAC in millimetre, hip and waist ratio will be performed from the day of enrollment till end of follow up. If participant agrees to participate, will be asked questions about their life style, present health status, and socio-demographic characteristics. The interview will around 30 minutes of their time, measurement of nutritional status (height, weight, MUAC, hip circumference, and waist circumference), and specimen collection for laboratory tests (blood and urine) will take another 30 minutes. Initially the follow up visits will be twice a month then once a month up to 4 consecutive months. Interviews will be conducted in the Kumudini Women's Medical College and Hospital. The data will be securely stored in a locked room. Data will be processed and analyzed by using the statistical software packages SPSS for Windows version 21.0 and Epi Info version 6.0. Statistical significance will be defined as p<0.05.

NCT ID: NCT03600025 Recruiting - Clinical trials for Typhoid Fever Patients and Healthy Volunteers to Receive Typbar-TCV Vaccine

Cellular Immune Responses in Typhoid Fever Patients and Vaccinees

Start date: July 15, 2018
Phase: Phase 1
Study type: Interventional

Typhoid fever caused by Salmonella Typhi and Paratyphi causes over 21 million cases of febrile illness and 200,000 deaths are attributed to enteric fever each year. Typhoid fever is an enteric infection that results in febrile illness. Typhoid fever causes significant morbidity in the developing world especially young children.S. Typhi specific antibody responses are elicited in typhoid fever and following typhoid vaccination. Cross-reactive multifunctional CD+4 T cell mediated IL-17 responses have been shown in typhoid fever. As S. Typhi as an intracellular pathogen, cellular immune responses might be central to protection. S. Typhi peptide subunit vaccine elicits CD+4 T cell responses that correlate with protection in mice. The role of mucosal associated invariant T cell (MAIT) and natural killer (NK) cell responses in typhoid fever or following vaccination remain poorly understood. Transcriptome profiling of human immune responses to S. Typhi infection is not clearly understood. Establishing successful infection by S. Typhi evasion of T cell and neutrophil responses need to be investigated to better understand the correlates of protection.