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

NCT07845669 | Not Yet Recruiting

• 1 other identifier: AU09264281250
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Control Group: Receiving standard post-transplant nutritional care based on clinical guidelines.
2. 2.Intervention Group: Receiving the same standard nutritional care plus a daily oral synbiotic capsule for 3 months.

Conditions

Malnutrition; Loss of Appetite; Anorexia; Dysbiosis; Hematologic Neoplasms; Gastrointestinal Symptoms

Keywords

Synbiotics; Autologous Bone Marrow Transplantation; Autologous Stem Cell Transplantation; Gut Microbiome; Probiotics; Prebiotics; Postbiotics; Tributyrin; Gastrointestinal Symptoms; Nutritional Recovery; Appetite; Fecal Calprotectin

Outcome Measures

Primary Outcomes (2)

• 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 / 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.

  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).

Secondary Outcomes (5)

• Change in Daily Dietary Energy and Protein Intake

  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)

  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

  Assessed at Baseline (Day 30 post-transplant) and Month 3 (Day 120 / end of intervention).

• Change in Serum Albumin Level

  Assessed at Baseline (Day 30 post-transplant) and Month 3 (Day 120 / end of intervention).

• Incidence of Treatment-Emergent Adverse Events and Supplement Tolerability

  From Baseline (Day 30 post-transplant) through post-intervention follow-up at Month 4 (Day 150).

Study Arms (2)

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.

Dietary Supplement: Tri-component Synbiotic Supplement

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.

Interventions

Tri-component Synbiotic Supplement DIETARY_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.

Also known as: Synbiotic (Probiotic + Prebiotic + Postbiotic)

Intervention Group (Synbiotic)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hematologically stable, clinically defined and laboratory-confirmed on day 30 post-transplant by:
• 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.
• Hemoglobin stability: Hemoglobin level \>= 8.0 g/dL without active bleeding or acute transfusion requirement.
• Discharged from the hospital and capable of oral intake and adherence to the daily supplement regimen.
• Capable of providing written informed consent.

You may not qualify if:

• 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.
• Current or regular use of other commercial probiotic, prebiotic, or synbiotic supplements within 30 days prior to enrollment.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Armed Forces Medical Complex in Alexandria

Alexandria, Alexandria Governorate, 21500, Egypt

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Malnutrition; Anorexia; Dysbiosis

Interventions

Synbiotics; Probiotics; Prebiotics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Dalia Ahmed Nafea, M.D., Ph.D.

  University of Alexandria

  STUDY CHAIR

Central Study Contacts

Mohamed Khalil Sharaf, Candidate for Master's Degree

CONTACT

+20 15 5715 1211; mohamedsharaf860@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months following publication of primary study results and ending 36 months after publication.
• Access Criteria: Data will be available to researchers whose proposed use of the data has been approved by an independent review committee and after signing a formal data use agreement. Requests should be directed to the study authors.

Locations

EG (1)