There are about 620 clinical studies being (or have been) conducted in Bangladesh. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
In cholera, the function of small intestine is affected resulting in increased secretion of electrolytes and water and their reduced absorption leading to profuse watery diarrhoea. The human colon has the capacity to absorb water and electrolytes. A number of recent studies have shown that short chain fatty acids (SCFAs) such as acetate, butyrate and propionate stimulates absorption of sodium in the colon, which is not affected by cyclic AMP. It has also been shown that SCFAs inhibits c-AMP mediated chloride secretion in the colon. Benefiber (partially hydrolyzed guar gum) is water soluble fibre, and when added to ORS it undergoes fermentation in the colon liberating SCFAs. SCFAs not only serves as metabolic fuel to the enterocytes but they also enhance colonic absorption of salts and water. Thus, they have potentials to reduce the severity of diarrhoea in patients with cholera. The aim of this study is to assess the efficacy of Benefiber-added WHO-ORS in the management of adults with cholera. In this randomized, controlled clinical trial, a total of 174 adult males with cholera would be studied. Study patients would be selected from those who attend the Dhaka Hospital of ICDDR,B with a history of diarrhoea of less than 24 hours and signs of severe dehydration. They would be rehydrated using intravenous fluid (cholera saline) over 4 hrs during which a stool specimen would be subjected for dark-field microscopy for identification of V. cholerae. Those identified to have cholera would be randomized in equal numbers to receive either: a) Benefiber (25 g/L) added WHO-ORS, b) Benefiber (50 g/L) added to the new formulation (Na+ 75, glucose 75, Cl- 65, K+ 20 mmol/L, citrate 10 mmol/L, osmolarity 245 mosmol/L) of WHO-ORS , or c) the same WHO-ORS but without Benefiber for maintenance of hydration until resolution of diarrhoea. All patients would be treated with a single, 300 mg dose of doxycycline capsules and would be provided with the standard hospital diets. Fluid intake (intravenous fluid, ORS, and plain water) and output (stool, urine, and vomit) will be measured for each 6-hourly periods of the study. Patients would be hospitalized until resolution of their diarrhoea. Stool output, intake of intravenous fluid and ORS, the duration of diarrhoea, and the proportion of patients requiring "unscheduled intravenous fluid therapy" would be compared between the treatment groups. If Benefiber is found effective, it would be possible to formulate improved ORS for better case management of cholera.
In developing countries, poor nutrition, high morbidity, poverty, poor parental education and stimulation in the home, all detrimentally affect children's development. These conditions frequently occur together increasing the risk of poor development. Iron deficiency anemia (IDA) affects large numbers of young children and is associated with poor child development. There is some question as to whether infants with IDA can catch up in mental development to non-IDA infants. We plan to examine the effect of psychosocial stimulation on IDA children's growth and development using a randomized controlled trial and compare them with non-anemic children. The study will be located in poor villages accessible to Dhaka. Villages will be randomized to either receive psychosocial stimulation or none. Children, aged 6-12 months, with IDA (hemoglobin (Hb) 80.0-109g/L, ferritin<12μg/L & Transferrin Recepter (TfR) >7) (n=212) or without anemia (Hb>109g/L, ferritin>12μg/L, C-reactive protein (CRP) <5 & TfR<7) (n=212) will be identified in those villages. Intervention will include weekly home visits for 9 months by a play leader, who will demonstrate play with home made toys and teach the mothers about child development. All IDA children will be given 30 mg ferrous-sulphate daily for 9 months. At the beginning and end of the study, the following measurements will be made: Bayley Scales of Infant Development (mental and motor indices), Wolke's behavior ratings, Hb, serum ferritin, CRP, Transferrin receptor, anthropometry, home stimulation, and mothers' knowledge and practices of child development. Stool microscopy, maternal-urinary iodine (as a proxy to assess children's iodine status), dietary history, child rearing practices (parenting) of mothers, perinatal history and socioeconomic conditions will be assessed at the beginning and children's language development at the end. Depending on availability of funds serum TSH will also be measured in children to exclude iodine deficiency. We will also measure mothers' nutritional and mental status to assess its relationship with children's development. The treatment effect will be examined by intention to treat analysis using multiple regression of the outcome variables controlling for initial measures and multilevel analysis will be conducted to control for differences at village level. The findings of this project will have implications both for international and national policies on early childhood development programs for IDA children.
A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.
The purpose of this study is to determine the safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.
With the long-term public health goal of developing an effective micronutrient supplementation program to improve child health by improving iron and zinc status and decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we seek to determine the most efficacious method of decreasing childhood morbidity and mortality due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and determining if this interaction can be minimized by separate administration of iron and zinc supplementation.
Cholera is a major health problem of many developing countries and marked increase in the prevalence has been seen on all continents in the last decade (WHO 1998). There is a great need for an appropriate vaccine to protect children the principal suffers in endemic countries, from the live threatening consequences of cholera. The B subunit-whole cell killed vaccine (Dukoral) developed in Sweden and used in field trials all over the world. It is licensed in many counties of the world and recommended by WHO. Protective efficacy to the killed vaccine has been demonstrated in adults in Bangladesh as well as in other countries, but less so in children (Clemens et al. 1986). Thus there is an urgency for developing strategies to improve the immunogenicity of vaccines especially for protection of children in cholera endemic countries of the world. Different options for improved cholera vaccines are being considered including new and improved formulations of killed or live oral candidate vaccines (Qadri et al. 2004, Sack et al. 1997, Levine et al. 1993) as well as the use of micronutrient supplementation during the course of immunization (Albert et al. 2003, Karlsen et al. 2003, Qadri et al. 2004). Another option that appears promising is the use of probiotics as adjunct to oral immunization based on the understanding that these agents could improve the mucosal immune responses, both innate and adaptive and help reducing inflammation (Blum and Schiffrin 2003, Fang et al. 2000). A therapeutic as well as preventive role of probiotics has been suggested from results of different studies using different probiotics that have been tested, usually lactic acid producing bacteria such as lactobacillus, Bifidobacterium and Steptococcus species. The supplemention of probiotics to infants may also have a prophylactic effect against acute diarrheal diseases. In pediatric populations, the effect of probiotic agents appears to be most significant against rotavirus diarrhea, suggesting that an immunological mechanism is responsible for the beneficial effects (Saavedra, 2000). In the present proposal we would like to examine if supplementation with the probiotic Bifidobacterium breve has a beneficial role in enhancing the immunogenicity of Dukoral in children. A two cell study will be conducted in which one group of children will be given B. breve every day for four weeks and another group will be given placebo. Two doses of the oral cholera vaccine will be administered at two week interval following initiation of the probiotic/placebo administration. Pre- and post- vaccination blood sample will be collected and assayed for immune response to the vaccine. The frequency and magnitude of the immune response to the vaccine will be compared among the two groups of children to assess whether the probiotic treatment enhances the immune responses to the vaccine. If probiotic supplemenation has a positive effect on the immune response it may be adopted as adjunct to enhance the efficacy of the cholera vaccine in immunization programmes and perhaps also of other enteric vaccines.
Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled "Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds". This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7±7 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (≥38°C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93±4)%, which was corrected by oxygen therapy (98±3)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7±2) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.
Primary objective: To assess response rate. To record the clinical improvement in relation to stage and histopathological grading. Secondary objective: To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.
A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution