Clinical Research Directory

Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)

This study is a hospital-based, prospective, multicentre cohort study (the HOSPIC-6 Study) that will follow infants under 6 months of age who are admitted to pediatric or perinatology wards with acute malnutrition, diagnosed according to the 2023 WHO criteria. The study will take place at Cipto Mangunkusumo Hospital (RSCM) in Jakarta, Indonesia, together with other hospitals all over Indonesia joining the HOSPIC-6 network, over a period of about one year. The purpose of this study is to: 1. Describe how common acute malnutrition is among infants under 6 months admitted to these hospitals 2. Observe what happens to these infants during nutrition treatment: whether they recover, whether their growth improves, or whether they experience complications or death. 3. Look at the factors associated with succesful nutrition therapy outcomes. After enrolment, each infant's weight, length, head circumference, and mid-upper arm circumference will be measured using standardized techniques, along with information about their birth history, feeding history, and any other illnesses. These measurements, along with details of the nutrition therapy provided, will be repeated on day 3, day 7, and then weekly until the infant is discharged from the hospital. All data will be recorded in a secure, password-protected electronic database (REDCap). No experimental drug or intervention will be given as part of this study; infants will receive the nutrition care that their treating doctors already provide as standard practice, and the study will only observe and record what happens. The information gathered from this study is expected to help doctors and health authorities better understand the scale of this problem in Indonesia and to support the development of clearer, evidence-based feeding and calorie guidelines for the treatment of acute malnutrition in infants under 6 months of age.

Washed Microbiota Transplantation for Malnutrition

Malnutrition is a pathological condition in which dietary intake fails to meet the body's energetic or nutritional needs. It may be caused by macronutrient or micronutrient deficiencies, high energy expenditure, impaired nutrient absorption or assimilation. Malnutrition can affect all stages of life. In adults, malnutrition is strongly associated with poor clinical outcomes such as increased morbidity, increased mortality and prolonged hospitalization. In children, malnutrition can lead to growth retardation, cognitive impairment and immune dysfunction.

Nutritional Assessment in Children With Cardiomyopathy

This cross-sectional study aims to determine the prevalence and pattern of malnutrition (acute wasting, chronic stunting, and micronutrient deficiency) among children with cardiomyopathy attending the Pediatric Cardiology Unit at Assiut University Children's Hospital.

Nutritional Status and Patient Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Older Hospitalized Patients

Disease-related malnutrition (DRM) describes undernutrition or imbalances in energy, protein, or other nutrient-needs, caused by a concomitant disease. Nutritional status plays a vital role in the fate of hospitalized patients, and DRM is associated with loss of function and decreased survival. DRM is a common condition in patients with acute illnesses, approximately 30% among medical inpatients are malnourished when admitteed to the hospital, and rise higher among the older or critically ill. Physiologically malnutrition is associated with a) poorer tissue healing and restitution after severe disease, b) suppressed immune function and resistance towards infections, c) poorer metabolic defense towards critical disease, d) delayed and poorer progress of chronic diseases. In addition, inadequate nutrition is coupled to a prolonged hospital stay, resulting in more readmissions, and overall higher mortality in hospital patients. Yet, nutritional status of patients upon hospital admittance is seldom systematically assessed and the consequences of DRM in older acutely admitted patients still needs to be understood. This project will provide a detailed description of nutritional, physiolgical, and biochemical status of 1500 acutely admitted patients. In relation, the study will investigate the relation between patient characteristics and disease progression. The obtained data will also be coupled to patient registers to investigate the link between length of hospital stay, readmissions and acute contact, and mortality.

Effects of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Recovery in Patients After Autologous Bone Marrow Transplant

Patients undergoing autologous bone marrow transplantation (ABMT) receive high-dose chemotherapy and routine prophylactic antibiotics, which often disrupt the gut microbiome (dysbiosis). This imbalance can lead to debilitating gastrointestinal complications, loss of appetite, decreased dietary intake, and malnutrition, impairing recovery. The purpose of this randomized controlled trial is to evaluate whether daily supplementation with a tri-component synbiotic (combining multispecies probiotics, xylo-oligosaccharide prebiotics, and a tributyrin postbiotic) can improve gastrointestinal symptoms, appetite, and nutritional status in adult hematological cancer patients following autologous bone marrow transplantation. Participants will be randomly assigned (1:1 ratio) to either: 1. Control Group: Receiving standard post-transplant nutritional care based on clinical guidelines. 2. Intervention Group: Receiving the same standard nutritional care plus a daily oral synbiotic capsule for 3 months. Participants will be followed during the 3-month intervention period and for an additional 1-month post-intervention follow-up phase to assess the sustainability of benefits. The study will evaluate digestive symptoms, self-reported appetite, dietary intake, body weight, inflammatory markers (fecal calprotectin), and protein status (serum albumin), while closely monitoring participant safety.

Nutrition in Patient With Critical Limb Ischemia

A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.

Individualized NUTRItional RISK and Oriented Nutritional Support

The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.

Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)

This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.

Tailored Stapled SADI-S: Initial Report and Preliminary Results

Obesity is a serious health problem worldwide and can lead to many diseases such as diabetes, high blood pressure, heart disease, and sleep apnea. When lifestyle changes and medications are not enough, metabolic and bariatric surgery (MBS) is currently the most effective and long-lasting treatment option. This study focuses on one of the newer types of bariatric surgery called Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S). This procedure combines two parts: Sleeve gastrectomy, which reduces the size of the stomach so the patient feels full after eating a small amount. Duodeno-ileal bypass, which shortens the path food takes through the small intestine to reduce calorie absorption. Our hospital's surgical team is studying a tailored version of this operation, where the length of the bypassed intestine is adjusted to each patient's anatomy. We believe this personalized approach may improve weight loss results while lowering the risk of vitamin and nutrient deficiencies. The study will include 40 adult patients with obesity who are undergoing SADI-S surgery, either as their first weight loss operation or as a revision surgery after an earlier sleeve gastrectomy. During the operation, surgeons will measure the total length of each patient's small intestine and use a formula to decide how much of it should be bypassed. The duodeno-ileal connection will be made using a stapled technique, which is expected to be safe and efficient. After surgery, patients will be followed regularly at 1, 3, 6, 9, and 12 months, and then once per year. At each visit, the study team will monitor weight loss, body mass index (BMI), resolution of diabetes and other obesity-related conditions, nutritional status (including vitamins and minerals), and any side effects such as diarrhea, reflux, or nutritional problems. The goal of this study is to learn whether this tailored SADI-S technique can provide strong, sustained weight loss and health improvement with fewer long-term complications. The results will help improve surgical planning for future patients by showing whether measuring and customizing the bypass length is safer and more effective than using a fixed length. All data collected will be kept confidential. Patients' participation in the study will not change their regular care or follow-up, and they can withdraw at any time without affecting their treatment.

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

Malnutrition is common in surgical patients. Many studies have shown a clear association between malnutrition and poor surgical outcomes. Parenteral nutrition (PN) is a nutrition intervention that is given by vein and can be safely provided to malnourished patients. It contains carbohydrates, fats, and protein just like you would normally in your diet. Pre-operative PN is able to improve outcomes in surgical patients. However, pre-operative PN has traditionally required hospital admission which results in increased length of stay, hospital cost, and hospital-acquired infection. Moreover, in hospital pre-operative PN may not be feasible or prioritized when access to inpatient surgery beds is limited. Outpatient PN provides the opportunity to solve this problem. The feasibility and impact of outpatient PN in malnourished patients undergoing major surgery have not previously been studied. This study aims to evaluate the feasibility of outpatient pre-operative PN and its effect on patient's outcomes.

The SAM Project: Science Against Malnutrition Project

The latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally. This condition is constantly increasing and affects the entire population, from childhood to the elderly. Malnutrition in all its forms negatively impacts the quality of life of patients affected and increases the risk of morbidity and mortality, as well as healthcare costs. Considering the complexity and multifactorial nature of malnutrition, the integration of multi-omics data obtained from analyzes with high-throughput technologies such as epigenomics, metagenomics, metabolomics, could benefit the prediction and evaluation of prognosis and/or response to specific treatments; this could pave the way for personalized precision medicine interventions for patients suffering from malnutrition. The SAM study aims to characterize malnutrition through the identification of specific biomarkers of the condition with the aim of developing innovative prevention and treatment programs.

Early Nutritional Intervention in Patients With Cancer

The goal of this intervention study is to study the effect of nutritional interventions in patients with cancer receiving palliative chemotherapy. The main question it aims to answer is: Does early nutritional interventions affect body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk and treatment tolerance in patients with cancer receiving palliative chemotherapy? Researchers will compare patients receiving the intervention to a historical control cohort following current clinical practice.

Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years

Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia.

Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients

Malnutrition and muscle wasting are frequent complications in patients with chronic obstructive pulmonary disease (COPD) experiencing acute exacerbations. In critically ill patients who require invasive mechanical ventilation, nutritional depletion and ventilator-induced diaphragmatic dysfunction can complicate recovery and prolong intensive care unit (ICU) stays. The purpose of this prospective observational cohort study is to evaluate nutritional status and diaphragmatic structure in elderly patients (aged 60 years and older) with COPD who require invasive mechanical ventilation for at least 48 hours. Participants will undergo bedside assessments, including: * Calculation of clinical risk scores within the first 24 hours of ICU admission: modified Nutrition Risk in the Critically Ill (mNUTRIC), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation II (APACHE II). * Anthropometric measurements: mid-upper arm circumference (MUAC) and calf circumference (CC) measured at baseline, day 7, and the day of weaning. * Diaphragmatic ultrasonography: point-of-care ultrasound to measure diaphragm thickness at end-expiration and end-inspiration at baseline, day 7, and during weaning trials. The main goal is to evaluate the relationship between nutritional risk (assessed by the mNUTRIC score) and diaphragmatic thickness, and to determine how these parameters correlate with clinical outcomes such as weaning success, total duration of mechanical ventilation, ICU length of stay, and ICU mortality.

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. The main objective aims to answer: What is the incidence of POD after gastroesophageal cancer surgery.

GNRI and Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery

This prospective observational study will evaluate whether nutritional risk and reduced muscle mass are associated with postoperative outcomes in adults aged 65 years or older undergoing surgery for hip fracture. Nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), which is calculated from routine preoperative serum albumin, body weight, and ideal body weight. Rectus femoris muscle thickness will be measured before surgery using a brief, noninvasive ultrasound examination of the non-fractured thigh. Participants will receive routine clinical care, and no treatment or anesthesia method will be assigned by the study. Clinical information will be collected from hospital records, including postoperative length of hospital stay, surgical site infection, and mortality. Survival status will be evaluated at 30 and 90 days after surgery using hospital records and/or telephone follow-up.

INEC Study: Immuno-modulating Enteral Nutrition in Cancer

The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet \[Impact (R), Novartis\] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors

Cancer patients have a higher risk of malnutrition because of their illness and treatments. This can lead to weight loss, weak muscles, less effective cancer therapy, or stronger side effects. This research project looks at whether adding a combined nutrition and exercise program to the standard treatment for appetite loss (olanzapine) can improve the quality of life for patients with cancer, compared to taking olanzapine alone. In this study, patients are randomly split into two groups. The program group gets advice from nutrition experts and physiotherapists. They also receive a nutritional supplement containing whey protein, leucine, and HMB (substances that help protect muscles). The control group continues their usual cancer treatment without the extra nutrition and exercise program. Both groups receive olanzapine as part of their standard care to treat loss of appetite, and both keep a diary to track their progress. Information will be collected at the start of the study, as well as after 6, 12, and 24 weeks. Nutritional advice and exercise are safe, easy-to-use steps that can help patients with cancer, especially when done together.

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

Implementation of Nutritional Efforts on Discharged Older Patients

The aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition. Data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status, physical function and quality of life

Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome

Introduction: Refeeding syndrome (RS) is a life-threatening metabolic complication of nutritional support. Prolonged fasting, frequently observed in malnourished patients referred for percutaneous endoscopic gastrostomy (PEG), induces histological and ultrastructural changes in the intestinal mucosa, potentially influencing RS development. Mixed-Meal Tolerance Tests (MMTT) combined with metabolomics allow dynamic assessment of serum glucose, gastrointestinal hormones and cellular metabolites, which may help to elucidate RS pathogenesis and assess patient risk. Objective: The present study aims to perform MMTT in PEG-fed patients to evaluate enteroendocrine hormone responses and metabolomic profiles following a prolonged fasting period and subsequent enteral refeeding. Methods: This prospective, single-center study includes adults referred for PEG after at least one month of oral intake below 50% of energy needs. The MMTT will be performed at PEG placement and after 3-6 months of enteral nutrition. Serial blood samples will be collected from baseline up to 120 minutes post-meal to measure serum glucose, insulin, C-peptide, electrolytes and gastrointestinal hormones (GLP-1/GIP/Ghrelin/Peptide YY), and for metabolomic profiling by spectroscopy. Clinical and nutritional data will be prospectively recorded. Statistical and multivariate analyses will assess metabolic and hormonal changes over time and their potential association with patient refeeding syndrome risk and clinical outcome. The study was approved by the institutional ethics committee, and patient informed consent will be obtained. Conclusion: This study integrates MMTT and metabolomic profiling to characterize hormonal and metabolic responses during fasting and refeeding in high-risk PEG patients. Findings are expected to reveal underlying mechanisms of RS, identify potential predictive biomarkers, and improve individualized risk stratification and nutritional management.

Nutritional Status in Patients With Chronic Kidney Disease

The goal of this observational study is to investigate how the GLIM criteria\* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are: * How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria? * How can information from other nutrition assessment tools be used in the operationalization of GLIM? * Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? This is an observational study on patients with CKD in hemodialysis. Variables are extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. Data collection started in the fall of 2024, and are collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units. Data on 2-year overall survival are also collected. * The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults

Prevention of Malnutrition in Children With Sickle Cell Disease

The investigators are studying how to prevent malnutrition in children with sickle cell disease (SCD) in northern Nigeria. Community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. The investigators will enroll 148 children with SCD aged 6 to 18 months old. The investigators will determine if their weight and diet improve and check for low vitamin A levels. This information will help us find better ways to improve growth for children with SCD.