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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fields
  2. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07845669
Lead Sponsor Alexandria University
Conditions
(from sponsor)
Hematologic Neoplasms, Gastrointestinal Symptoms, Malnutrition, Loss of Appetite, Anorexia, Dysbiosis
Related terms Anorexia, Dysbiosis, Hematologic Neoplasms, Malnutrition
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov