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.
Adult patients aged 20 to 65 years with hematological malignancies.
Having undergone successful autologous bone marrow transplantation with confirmed neutrophil and platelet engraftment on day 30 post-transplant.
Neutrophil engraftment: Absolute Neutrophil Count (ANC) >= 1,500/mcL (or >= 1.5 x 10^9/L) maintained for at least 3 consecutive days without hematopoietic growth factor support.
Platelet engraftment: Platelet count >= 20,000/mcL (or >= 50,000/mcL according to institutional safety protocols) sustained without platelet transfusion for at least 7 consecutive days.
Pre-existing severe gastrointestinal disorders (e.g., inflammatory bowel disease, active enteritis, or history of colorectal surgery/resection).
Severe renal or hepatic impairment (e.g., pre-existing documented history or established clinical diagnosis of advanced renal failure, active requirement for renal replacement therapy, or decompensated liver disease, verified directly from institutional medical records).
Active, prolonged high-dose systemic corticosteroid therapy or uncontrolled diabetes mellitus that may independently alter gastrointestinal motility, mucosal integrity, or appetite regulation.
Known allergies or hypersensitivity to any component of the synbiotic formulation.
Parallel
Tri-component Synbiotic Supplement
Dietary supplementDaily oral capsule containing: 1) Multispecies Probiotics (10 billion CFU: Lactobacillus acidophilus, Lactobacillus rhamnosus, Bacillus subtilis, Bifidobacterium animalis subsp. lactis, Bifidobacterium bifidum, Bifidobacterium longum, Saccharomyces boulardii); 2) Prebiotic: Xylo-oligosaccharides (XOS, 100 mg); 3) Postbiotic: Tributyrin (210 mg). Administered once daily for 3 months (from Day 30 to Day 120 post-transplant), timed at least 2 to 3 hours apart from routine prophylactic antibiotics.
Change in Gastrointestinal Symptoms Score using Gastrointestinal Symptom Rating Scale (GSRS)
Evaluated using the validated Arabic version of the Gastrointestinal Symptom Rating Scale (GSRS). The instrument comprises 15 items categorized into five symptom clusters: reflux, abdominal pain, indigestion, diarrhea, and constipation. Each item is rated on a 7-point Likert scale ranging from 1 (no discomfort) to 7 (very severe discomfort). Total scores range from 15 to 105, where lower scores represent fewer symptoms and better gastrointestinal tolerance.
Change in Patient-Reported Appetite Score using the Council on Nutrition Appetite Questionnaire (CNAQ)
Evaluated using the validated Arabic version of the Council on Nutrition Appetite Questionnaire (CNAQ). The questionnaire consists of 8 items assessing appetite perception, taste of food, meal frequency, mood, and satiety. Each item is rated on a 5-point scale, generating a total score ranging from 8 to 40. Higher scores indicate improved appetite, while a score of 28 or lower indicates poor appetite and significant risk of weight loss.
Change in Daily Dietary Energy and Protein Intake
Assessed quantitatively using 3-day 24-hour dietary recalls (conducted on three non-consecutive days) and analyzed using the Egyptian Food Composition Tables to determine actual daily caloric intake (kcal/day) and protein intake (grams/day and g/kg/day).
Change in Body Weight and Body Mass Index (BMI)
Body weight (kg) is measured using a calibrated digital scale according to standardized anthropometric procedures. Body Mass Index (BMI) is calculated as weight in kilograms divided by height in meters squared (kg/m²).
Change in Fecal Calprotectin Concentration
Stool samples are quantitatively analyzed for fecal calprotectin concentration (expressed in mcg/g) using enzyme-linked immunosorbent assay (ELISA) as an objective laboratory biomarker to assess intestinal mucosal inflammation and gut barrier integrity.
Change in Serum Albumin Level
Venous blood samples are quantitatively analyzed for serum albumin concentration (expressed in g/dL) using standardized automated laboratory colorimetric assays as an objective biochemical marker reflecting nutritional and inflammatory status.
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