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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Change in Gastrointestinal Symptoms Score using Gastrointestinal Symptom Rating Scale (GSRS) — 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).
  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) — 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).
  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.

Trial sites (1)

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