[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657999":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":34,"armGroups":43,"interventions":54,"overallOfficials":62,"centralContacts":67,"locations":73,"responsibleParty":87,"collaborators":34,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":34,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":34,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":115,"overallStatus":127,"whyStopped":34,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Assessed at Baseline (Day 30 post-transplant), Month 1 (Day 60), Month 2 (Day 90), Month 3 (Day 120 \u002F end of intervention), and Month 4 (Day 150 \u002F post-intervention follow-up).",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20,23,27,30],{"measure":18,"description":19,"timeFrame":12},"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\u002Fday) and protein intake (grams\u002Fday and g\u002Fkg\u002Fday).",{"measure":21,"description":22,"timeFrame":12},"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\u002Fm²).",{"measure":24,"description":25,"timeFrame":26},"Change in Fecal Calprotectin Concentration","Stool samples are quantitatively analyzed for fecal calprotectin concentration (expressed in mcg\u002Fg) using enzyme-linked immunosorbent assay (ELISA) as an objective laboratory biomarker to assess intestinal mucosal inflammation and gut barrier integrity.","Assessed at Baseline (Day 30 post-transplant) and Month 3 (Day 120 \u002F end of intervention).",{"measure":28,"description":29,"timeFrame":26},"Change in Serum Albumin Level","Venous blood samples are quantitatively analyzed for serum albumin concentration (expressed in g\u002FdL) using standardized automated laboratory colorimetric assays as an objective biochemical marker reflecting nutritional and inflammatory status.",{"measure":31,"description":32,"timeFrame":33},"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.","From Baseline (Day 30 post-transplant) through post-intervention follow-up at Month 4 (Day 150).",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","A single-center, open-label, randomized, parallel-group controlled trial with a 1:1 allocation ratio. Eligible patients following autologous bone marrow transplantation will be randomly allocated to either the intervention group (tri-component synbiotic plus standard nutritional care) or the control group (standard nutritional care alone) for a 3-month intervention period, followed by a 1-month post-intervention observational follow-up period.","SUPPORTIVE_CARE",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE","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.\n\nThe active supplement combines three synergistic elements:\n\n1. Multispecies Probiotics (10 billion CFU per daily capsule): Lactobacillus acidophilus, Lactobacillus rhamnosus, Bacillus subtilis, Bifidobacterium animalis subsp. lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Saccharomyces boulardii.\n2. Prebiotic: Xylo-oligosaccharides (XOS, 100 mg) to selectively nourish Bifidobacterium and Lactobacillus genera.\n3. Postbiotic: Tributyrin (210 mg), a stable butyrate precursor supporting intestinal mucosal epithelial barrier integrity and reducing inflammatory signaling.\n\nAll 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.\n\nStudy Timeline and Procedures:\n\n1. Baseline (Day 30 post-ABMT): Following confirmation of successful engraftment (Absolute Neutrophil Count \\>= 1,500\u002FuL, sustained platelet count \\>= 20,000\u002FuL, and hemoglobin \\>= 8.0 g\u002FdL), patients complete baseline assessments and provide fasting blood and stool specimens.\n2. Intervention Phase (Day 30 to Day 120 post-transplant): Participants undergo weekly clinical and safety follow-up evaluations. Questionnaires, 24-hour dietary recalls (3 non-consecutive days), and anthropometric measurements are repeated at Month 1 (Day 60), Month 2 (Day 90), and Month 3 (Day 120 \u002F End of Intervention). Fasting blood (serum albumin) and stool samples (routine examination and fecal calprotectin) are recollected at Day 120.\n3. Follow-up Phase (Day 120 to Day 150 post-transplant): A 30-day post-supplementation observational window to assess sustained clinical effects without supplement administration, concluding with a comprehensive evaluation at Day 150.\n\nSafety Oversight:\n\nWeekly 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.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Intervention Group (Synbiotic)","EXPERIMENTAL","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.",[49],"Dietary Supplement: Tri-component Synbiotic Supplement",{"label":51,"type":52,"description":53,"interventionNames":34},"Control Group (Standard Care)","NO_INTERVENTION","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.",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DIETARY_SUPPLEMENT","Tri-component Synbiotic Supplement","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.",[45],[61],"Synbiotic (Probiotic + Prebiotic + Postbiotic)",[63],{"name":64,"affiliation":65,"role":66},"Dalia Ahmed Nafea, M.D., Ph.D.","University of Alexandria","STUDY_CHAIR",[68],{"name":69,"role":70,"phone":71,"phoneExt":34,"email":72},"Mohamed Khalil Sharaf, Candidate for Master's Degree","CONTACT","+20 15 5715 1211","mohamedsharaf860@gmail.com",[74],{"facility":75,"status":34,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":34},"Armed Forces Medical Complex in Alexandria","Alexandria","Alexandria Governorate","21500","Egypt","EG",{"type":82,"coordinates":83},"Point",[84,85],29.91582,31.20176,{"lat":85,"lon":84},{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Mohamed Khalil Ibrahim Sharaf","Principal Investigator","100657999","effects-of-synbiotic-supplementation-on-gastrointestinal-symptoms-appetite-and-nutritional-recovery-in-patients-after-autologous-bone-marrow-transplant-100657999",false,"NCT07845669","Effects of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Recovery in Patients After Autologous Bone Marrow Transplant","Efficacy of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Status Following Autologous Bone Marrow Transplantation: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients aged 20 to 65 years with hematological malignancies.\n* Having undergone successful autologous bone marrow transplantation with confirmed neutrophil and platelet engraftment on day 30 post-transplant.\n* Hematologically stable, clinically defined and laboratory-confirmed on day 30 post-transplant by:\n* Neutrophil engraftment: Absolute Neutrophil Count (ANC) \\>= 1,500\u002FmcL (or \\>= 1.5 x 10\\^9\u002FL) maintained for at least 3 consecutive days without hematopoietic growth factor support.\n* Platelet engraftment: Platelet count \\>= 20,000\u002FmcL (or \\>= 50,000\u002FmcL according to institutional safety protocols) sustained without platelet transfusion for at least 7 consecutive days.\n* Hemoglobin stability: Hemoglobin level \\>= 8.0 g\u002FdL without active bleeding or acute transfusion requirement.\n* Discharged from the hospital and capable of oral intake and adherence to the daily supplement regimen.\n* Capable of providing written informed consent.\n\nExclusion Criteria:\n\n* Pre-existing severe gastrointestinal disorders (e.g., inflammatory bowel disease, active enteritis, or history of colorectal surgery\u002Fresection).\n* 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).\n* Active, prolonged high-dose systemic corticosteroid therapy or uncontrolled diabetes mellitus that may independently alter gastrointestinal motility, mucosal integrity, or appetite regulation.\n* Known allergies or hypersensitivity to any component of the synbiotic formulation.\n* Current or regular use of other commercial probiotic, prebiotic, or synbiotic supplements within 30 days prior to enrollment.","ALL","20 Years","65 Years",{"count":102,"type":103},40,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.\n\nThe 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.\n\nParticipants will be randomly assigned (1:1 ratio) to either:\n\n1. Control Group: Receiving standard post-transplant nutritional care based on clinical guidelines.\n2. Intervention Group: Receiving the same standard nutritional care plus a daily oral synbiotic capsule for 3 months.\n\nParticipants 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.",[109,110,111,112,113,114],"Hematologic Neoplasms","Gastrointestinal Symptoms","Malnutrition","Loss of Appetite","Anorexia","Dysbiosis",[116,117,118,119,120,121,122,123,110,124,125,126],"Synbiotics","Autologous Bone Marrow Transplantation","Autologous Stem Cell Transplantation","Gut Microbiome","Probiotics","Prebiotics","Postbiotics","Tributyrin","Nutritional Recovery","Appetite","Fecal Calprotectin","NOT_YET_RECRUITING","2026-09-28",{"date":130,"type":131},"2026-10-01","ACTUAL",{"date":130,"type":103},{"date":134,"type":103},"2028-03-01",{"name":5,"class":6},1]