An interventional study of Tri-component Synbiotic Supplement in Hematologic Neoplasms, Gastrointestinal Symptoms and Malnutrition, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care
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:
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.
High-dose conditioning chemotherapy and routine prophylactic antibiotic administration in patients undergoing autologous bone marrow transplantation (ABMT) severely compromise the gastrointestinal microenvironment, resulting in acute dysbiosis, gut mucosal disruption, decreased appetite, and acute weight loss. This single-center, open-label, randomized, parallel-group trial evaluates the clinical efficacy and mechanistic impact of a tri-component synbiotic formulation designed to counteract post-transplant dysbiosis.
The active supplement combines three synergistic elements:
All supplement units are sourced from a single uniform manufacturing batch produced under Good Manufacturing Practice (GMP) standards, with microbiological purity and strain viability validated through independent accredited laboratory testing prior to administration. Participants are instructed to ingest the capsule daily, maintaining an interval of at least 2 to 3 hours apart from broad-spectrum antibiotics to preserve live strain viability.
Study Timeline and Procedures:
Safety Oversight:
Weekly monitoring tracks adverse events, febrile episodes (>= 38.0°C), gastrointestinal tolerance, and late-onset cytopenias. Any suspected microbial translocation or serious adverse event mandates immediate supplement cessation and clinical investigation.
Exclusion Criteria:
Participants receive standard post-transplant nutritional care plus daily oral supplementation with a tri-component synbiotic capsule (containing 10 billion CFU multispecies probiotics, 100 mg xylo-oligosaccharides prebiotic, and 210 mg tributyrin postbiotic) for 3 months (from Day 30 to Day 120 post-ABMT), followed by a 1-month observational follow-up period.
Dietary Supplement: Tri-component Synbiotic Supplement
Participants receive standard post-transplant nutritional care alone based on clinical practice guidelines without any synbiotic or placebo supplementation for 3 months (from Day 30 to Day 120 post-ABMT), followed by a 1-month observational follow-up period.
Daily 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.
Also known as: Synbiotic (Probiotic + Prebiotic + Postbiotic)
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.
Time frame: Assessed at Baseline (Day 30 post-transplant), Month 1 (Day 60), Month 2 (Day 90), Month 3 (Day 120 / end of intervention), and Month 4 (Day 150 / post-intervention follow-up).
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.
Time frame: Assessed at Baseline (Day 30 post-transplant), Month 1 (Day 60), Month 2 (Day 90), Month 3 (Day 120 / end of intervention), and Month 4 (Day 150 / post-intervention follow-up).
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).
Time frame: Assessed at Baseline (Day 30 post-transplant), Month 1 (Day 60), Month 2 (Day 90), Month 3 (Day 120 / end of intervention), and Month 4 (Day 150 / post-intervention follow-up).
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).
Time frame: Assessed at Baseline (Day 30 post-transplant), Month 1 (Day 60), Month 2 (Day 90), Month 3 (Day 120 / end of intervention), and Month 4 (Day 150 / post-intervention follow-up).
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.
Time frame: Assessed at Baseline (Day 30 post-transplant) and Month 3 (Day 120 / end of intervention).
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.
Time frame: Assessed at Baseline (Day 30 post-transplant) and Month 3 (Day 120 / end of intervention).
Incidence of Treatment-Emergent Adverse Events and Supplement Tolerability
Continuous monitoring, recording, and assessment of all reported adverse events, gastrointestinal intolerances, infectious complications, and safety issues potentially related to synbiotic supplementation throughout the study duration.
Time frame: From Baseline (Day 30 post-transplant) through post-intervention follow-up at Month 4 (Day 150).
Plan to share: Yes — De-identified individual participant data underlying the results reported in published articles will be shared with qualified academic researchers upon reasonable request, after publication of the primary trial results, subject to institutional ethical review and a data access agreement.
Supporting information: Study protocol, Sap, Icf
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Alexandria University