Hematologic NeoplasmsNCT07845669
Effects of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Recovery in Patients After Autologous Bone Marrow Transplant
A study testing Tri-component Synbiotic Supplement in people with Hematologic Neoplasms and Gastrointestinal Symptoms, run by Alexandria University at 1 site in Egypt.
Trial summary
Patients undergoing autologous bone marrow transplantation (ABMT) receive high-dose chemotherapy and routine prophylactic antibiotics, which often disrupt the gut microbiome (dysbiosis). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hematologic Neoplasms, Gastrointestinal Symptoms, Malnutrition
- What is being tested?
- Tri-component Synbiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Khalil Sharaf, Candidate for Master's Degree contact
Egypt1 site
Armed Forces Medical Complex in Alexandria
Alexandria, Alexandria Governorate, 21500
About this study
Official title: Efficacy of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Status Following Autologous Bone Marrow Transplantation: A Randomized Controlled Trial
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.
Read more
Participants will be randomly assigned (1:1 ratio) to either:
- Control Group: Receiving standard post-transplant nutritional care based on clinical guidelines.
- 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.
Read the detailed description
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:
- 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.
- Prebiotic: Xylo-oligosaccharides (XOS, 100 mg) to selectively nourish Bifidobacterium and Lactobacillus genera.
- Postbiotic: Tributyrin (210 mg), a stable butyrate precursor supporting intestinal mucosal epithelial barrier integrity and reducing inflammatory signaling.
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:
- Baseline (Day 30 post-ABMT): Following confirmation of successful engraftment (Absolute Neutrophil Count >= 1,500/uL, sustained platelet count >= 20,000/uL, and hemoglobin >= 8.0 g/dL), patients complete baseline assessments and provide fasting blood and stool specimens.
- 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 / End of Intervention). Fasting blood (serum albumin) and stool samples (routine examination and fecal calprotectin) are recollected at Day 120.
- 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.
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.
- Conditions
- Hematologic Neoplasms, Gastrointestinal Symptoms, Malnutrition, Loss of Appetite, Anorexia, Dysbiosis
- Being tested
- Tri-component Synbiotic Supplement
- Keywords
- Synbiotics, Autologous Bone Marrow Transplantation, Autologous Stem Cell Transplantation, Gut Microbiome, Probiotics, Prebiotics, Postbiotics, Tributyrin, Gastrointestinal Symptoms, Nutritional Recovery, Appetite, Fecal Calprotectin
- Medical subject headings
- Hematologic Neoplasms, Malnutrition, Anorexia, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-component Synbiotic SupplementDietary supplement
Also called Synbiotic (Probiotic + Prebiotic + Postbiotic)
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Day 30 post-transplant) through post-intervention follow-up at Month 4 (Day 150).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalil Ibrahim Sharaf, Alexandria University
- Investigators
- Dalia Ahmed Nafea, M.D., Ph.D., Study chair, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845669
- Sponsor's protocol ID
- AU09264281250
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Status Following Autologous Bone Marrow Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845669
- Acronym / sponsor ID
- AU09264281250
- Conditions
- Hematologic Neoplasms, Gastrointestinal Symptoms, Malnutrition, Loss of Appetite, Anorexia, Dysbiosis
- Keywords
- Synbiotics, Autologous Bone Marrow Transplantation, Autologous Stem Cell Transplantation, Gut Microbiome, Probiotics, Prebiotics, Postbiotics, Tributyrin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Control Group: Receiving standard post-transplant nutritional care based on clinical guidelines.
- 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.
Detailed description
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:
- 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.
- Prebiotic: Xylo-oligosaccharides (XOS, 100 mg) to selectively nourish Bifidobacterium and Lactobacillus genera.
- Postbiotic: Tributyrin (210 mg), a stable butyrate precursor supporting intestinal mucosal epithelial barrier integrity and reducing inflammatory signaling.
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:
- Baseline (Day 30 post-ABMT): Following confirmation of successful engraftment (Absolute Neutrophil Count >= 1,500/uL, sustained platelet count >= 20,000/uL, and hemoglobin >= 8.0 g/dL), patients complete baseline assessments and provide fasting blood and stool specimens.
- 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 / End of Intervention). Fasting blood (serum albumin) and stool samples (routine examination and fecal calprotectin) are recollected at Day 120.
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Synbiotic) | Experimental | Dietary Supplement: Tri-component Synbiotic SupplementParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tri-component Synbiotic SupplementAlso: Synbiotic (Probiotic + Prebiotic + Postbiotic)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. | Dietary supplement | Intervention Group (Synbiotic) |
Primary outcome
Change in Gastrointestinal Symptoms Score using Gastrointestinal Symptom Rating Scale (GSRS)
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).
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)
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).
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.
5 secondary outcomes
Change in Daily Dietary Energy and Protein Intake
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)
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
Time frame: Assessed at Baseline (Day 30 post-transplant) and Month 3 (Day 120 / end of intervention).
Change in Serum Albumin Level
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
Time frame: From Baseline (Day 30 post-transplant) through post-intervention follow-up at Month 4 (Day 150).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Khalil Sharaf, Candidate for Master's Degree contact
Dalia Ahmed Nafea, M.D., Ph.D. study chair
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-component Synbiotic Supplement in people with Hematologic Neoplasms and Gastrointestinal Symptoms, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khalil Sharaf, Candidate for Master's Degree (+20 15 5715 1211, mohamedsharaf860@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptoms Score using Gastrointestinal Symptom Rating Scale (GSRS) (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.