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 2026-10-01.
Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care
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Among 12 studies in Hematologic Neoplasms with a site in Egypt — 6 open to participants now, 6 under way, none of them phase 3. Hematologic Neoplasms · Egypt.
Among the 12 studies in Hematologic Neoplasms with a site in Egypt, this one is the only one that started in 2026, is one of 2 with no phase, and was the 12th registered.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
Browse Hematologic Neoplasms studies →6 of the 12 studies in Hematologic Neoplasms with a site in Egypt are open now. Recruiting first, the newest first:
Asmaa Hassan mohamed Abdel Mawjoud · Sites in Egypt
Healthy volunteers
Alexandria University · Sites in Egypt
Ages 18–65
Assiut University · Sites in Egypt
Ages 18–80
Hikma Pharmaceuticals LLC · Sites in Egypt
Ages 18+
Assiut University · Sites in Egypt
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.
This study: 20 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Median enrollment 84 across the 6 interventional studies, 97 across the 6 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 12 have an industry lead sponsor. The 7 most frequent:
Alexandria University is the lead sponsor of 607 studies on the registry; 142 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Alexandria University has 2 studies filed under Hematologic Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Hematologic Neoplasms with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07108010Assiut UniversityABO and Rh Blood Group Frequencies in Acute Leukemia Patients | 2026-12-30 |
| NCT07300735Alexandria UniversityComparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers | 2027-03 |
| NCT04546945Asmaa Hassan mohamed Abdel MawjoudAberrant Expression of CD56 in Patients With Hematologic Malignancies. | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 12 studies in Hematologic Neoplasms with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 185 non-industry interventional studies with no phase under Hematologic Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 82. This study's planned 14 months is below that.
Counting every sponsor, half of 191 studies reached it within 40 months; a quarter within 21 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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