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Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation
In Brief
A clinical study evaluating Traditional Control and Oral Nutritional Supplement for Haematological Malignancy. Completed, enrolled 100 participants across 1 site.
Detailed Summary
Malnutrition is common after haematopoietic stem cell transplantation (HSCT), and is a well-known prognostic factor for survival. HSCT-associated treatments are metabolic and digestively intolerant, hence can induce a significant reduction in oral intake. Thus weight loss, as well as a reduction in serum albumin, and pre-albumin levels, are frequent following HSCT. Although the gut remains functional, sore mouth, mucositis, dysphagia, nausea, vomiting, and diarrhoea will inevitably hinder the implementation of enteral nutrition (EN), thus leading to a deficit between daily intake and requirement. Side effects of chemotherapy and antibiotics in combine will contribute to the alteration of intestinal flora on top of the existing gut symptoms, further impairing nutrient digestion and absorption. Oral nutritional supplements (ONS) are foods for special medical purposes (FSMP) that are specially formulated for oral nutritional support. Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN, however, the data is sparse in China to support the safety of usage amongst this population. On the other side, what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT. It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms. The study is a prospective study. All the participants will be recruited from a single research center (Renji Hospital). The participants will be randomized into two groups: traditional treatment or ONS. Ensure complete (Abbott), which contains soluble dietary fiber such as fructo-oligosaccharide (FOS) and inulin, will be served as the ONS for testing. The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation. The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following: body weight, fat-free mass, circumference, handgrip test, and patient-generated global subjective assessment. The tolerability of supplementing ONS and its' effect on gut function as well as on infection rate is also of interest.
Study Details
Timeline
Interventions
Placebo control is a compounded made-up shake that is traditionally used by the Haematology ward to supplement patients receiving HSCT. The control provides an equivalent of 500kcals and 20.6g protein, 3.4g fiber per day. The participants will be randomly assigned to consume the control twice daily for the duration of 7 days prior to the admission to the day of discharge.
The product to be studied is a standard polymeric formula. It is intended to provide 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly presented in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants will be randomly assigned to consume the intervention twice a day for the duration of 7 days prior to the admission to the day of discharge.