Haematological MalignancyNCT05460013
Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation
A study testing Oral Nutritional Supplement in people with Haematological Malignancy, run by RenJi Hospital at 1 site in China.
Trial summary
Malnutrition is common after haematopoietic stem cell transplantation (HSCT), and is a well-known prognostic factor for survival. HSCT-associated treatments are metabolic and digestively intolerant, hence can induce a significant reduction in oral intake. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Haematological Malignancy
- What is being tested?
- Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned for HSCT
- No contraindications to enteral nutrition
- Able to consent
Who cannot join
- Existing contraindications to enteral nutrition
- Existing infectious diarrhoea
- Had other malignancies
- Had gut surgery in a year
- Had used prebiotics or probiotics or synbiotic in a month
- Immunosuppressive OR prolonged corticosteroid therapy (more than three months)
Show all 9Show fewer
- Pregnancy or lactation
- Had an allergy, or intolerance to ingredients of dietary supplements
- Judged to be unsafe to tolerate fiber
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200124
About this study
Official title: Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation
Malnutrition is common after haematopoietic stem cell transplantation (HSCT), and is a well-known prognostic factor for survival. HSCT-associated treatments are metabolic and digestively intolerant, hence can induce a significant reduction in oral intake. Thus weight loss, as well as a reduction in serum albumin, and pre-albumin levels, are frequent following HSCT. Although the gut remains functional, sore mouth, mucositis, dysphagia, nausea, vomiting, and diarrhoea will inevitably hinder the implementation of enteral nutrition (EN), thus leading to a deficit between daily intake and requirement. Side effects of chemotherapy and antibiotics in combine will contribute to the alteration of intestinal flora on top of the existing gut symptoms, further impairing nutrient digestion and absorption.
Oral nutritional supplements (ONS) are foods for special medical purposes (FSMP) that are specially formulated for oral nutritional support. Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN, however, the data is sparse in China to support the safety of usage amongst this population. On the other side, what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT. It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms.
Read more
The study is a prospective study. All the participants will be recruited from a single research center (Renji Hospital). The participants will be randomized into two groups: traditional treatment or ONS. Ensure complete (Abbott), which contains soluble dietary fiber such as fructo-oligosaccharide (FOS) and inulin, will be served as the ONS for testing.
The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation. The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following: body weight, fat-free mass, circumference, handgrip test, and patient-generated global subjective assessment. The tolerability of supplementing ONS and its' effect on gut function as well as on infection rate is also of interest.
Read the detailed description
Standard Operating Procedures:
The study is located in Renji Hospital Stem Cell Transplant Unit, including Haematology Outpatient Department and Clinical Nutrition Department. All the patients aged between 18 and 75 years planned for HSCT and who are able to understand and sign an informed consent form are eligible for the study. The potential participants will be provided with the information sheet by the dietitian on the day of their outpatient pre-assessment visit. Each participant will be allocated with a study-specific code to protect their confidentiality. After recruitment, the participants will be asked to consume either the placebo control OR the ONS for testing, intended for supplementation for the duration of 7 days prior to HSCT admission. Anthropometry, biochemistry, and functional assessments are planned at four time points: before admission (baseline), the day of transplantation (D0), 14 days post-transplantation (D14) and 28 days post-transplantation (D28). In addition, nutritional intakes and gut assessments will be collected for the duration of the whole admission. If a subject is discharged home before D14 or D28, then these will be attempted at the appropriate time when the patient attended Haematology Outpatients for medical follow-up visits. Teleconsultation might be involved if the visit is not possible. All the data will be stored in an electronic database. It will be password protected with access only restricted to major investigators. All adverse events occurring within the trial will be collected at each visit for assessment of safety.
Sample Size Assessment:
A total number of 100 participants is determined necessary to demonstrate an effect. This sample size is designed to provide 85% power to detect a 1.2kg difference in body weight using an alpha=0.05(two-sided) to account for comparisons.
Plan for missing data:
A variable could be reported as missing by reasons possibly associated with logistic issues or participants declined to take the measurements. Strategy to minimize missing data includes setting up planning and time schedule in the Excel sheet to keep all the investigators notified.
Statistical Analysis Plan:
The demographic and clinical characteristics of patients will be summarized using descriptive statistics. Data analysis will be carried out using Statistical Analysis System (SAS) 9.4. Statistical analysis software. The mean or median change in continuous variables between the group by time points is assessed using t-test or Wilcoxon's rank sum test. Changes in categorical variables is assessed using Pearson chi-square or McNemar's test. Analysis of covariance or Analysis of variance might be applied as needed.
- Conditions
- Haematological Malignancy
- Being tested
- Traditional Control, Oral Nutritional Supplement
- Keywords
- Hematopoietic Stem Cell Transplantation, Oral Nutritional Supplements, Body Weight, Body Composition
- Medical subject headings
- Hematologic Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ControlDietary supplement
Placebo control is a compounded made-up shake that is traditionally used by the Haematology ward to supplement patients receiving HSCT. The control provides an equivalent of 500kcals and 20.6g protein, 3.4g fiber per day. The participants will be randomly assigned to consume the control twice daily for the duration of 7 days prior to the admission to the day of discharge.
Oral Nutritional SupplementDietary supplement
Also called Ensure Complete (Abbott)
The product to be studied is a standard polymeric formula. It is intended to provide 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly presented in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants will be randomly assigned to consume the intervention twice a day for the duration of 7 days prior to the admission to the day of discharge.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Not described Receives: Dietary Supplement: Traditional Control |
| Oral Nutritional Intervention | Experimental | Not described Receives: Dietary Supplement: Oral Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Between-group Change for Body Weight
It quantifies the difference in weight change between the groups. Body weight is assessed in kilograms.
Measured: It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two arms
Secondary outcomes (11)
The Within-group Change for Body Weight (Ensure)
It measures the within-group change for body weight in the ensure group. Body weight is assessed in kilograms
Measured: It measures the change in body weight within the Ensure group from baseline to three time points post-transplantation, namely the day of transplantation, 14 days post transplantation and 28 days post transplantation
The Within-group Change for Body Weight (Control)
It measures the within-group change for body weight in the control group. Body weight is assessed in kilograms
Measured: It measures the change in body weight within the control group from baseline to three time points post-transplantation, namely the day of transplantation, 14 days post transplantation and 28 days post transplantation
The Between-group and Within-group Change for Fat-free Mass
It measures the between-group and within-group change for Fat-free mass. Fat-free mass is assessed in kilograms.
Measured: The fat-free mass was measured at baseline and at 28 days post transplantation. Then the change from baseline to 28 days post transplantation were compared.
The Between-group and Within-group Change for Calf Circumference
It measures the between-group and within-group change for calf circumference. Calf circumference is assessed in centimeters.
Measured: The calf circumference was measured at baseline, at the day of transplantation, 14 days post transplantation and 28 days post transplantation. Then the change from baseline to these three timepoints were compared.
It Measures the Between-group and Within-group Change for the Handgrip Test.
It measures the between-group and within-group change for the handgrip test. Handgrip test is assessed in kilograms.
Measured: The handgrip test was conducted at baseline, at the day of transplantation, 14 days post transplantation and 28 days post transplantation. Then the change from baseline to these three timepoints were compared.
The Within-group and Between-group Change for Patient-Generated Subjective Global Assessment
Patient-Generated Subjective Global Assessment (PG-SGA) is a universally used nutritional assessment tool. An additive score is used to define specific nutritional interventions. Scale title is nutritional triage recommendations, with the score of 0 referring to no intervention required at this time and more than 9 scores indicating a critical need for intervention. Of note, the minimum value is 0 and there is no maximum value. A higher value means a worse outcome.
Measured: PG-SGA was conducted at baseline and at 28 days post transplantation. Then the change in PG-SGA scores between these two timepoints were compared.
The Within-group and Between-group Change for Microbiota Diversity
The alpha diversity index is a quantitative measure that reflects the number of different bacterial species present in a sample. The index is unitless, it is a pure number derived from proportions. The index can be interpreted through sobs, shannon, and simpson index. Sobs index is the raw count of species (distinct microbial types), with higher number indicating a higher richness. Shannon index is calculated from the proportion of each species, with no range exists. The simpson index is a probability (range 0-1), with higher values indicating less abundant species.
Measured: The stool samples were collected at the time of laminar room admission and 14 days post transplantation. Then the change in alpha-diversity index between this two time-points were compared.
The Within-group Change for Microbiota-derived Metabolites in Urine
The diversity is assessed through urine samples. For practical considerations, urine samples were collected at the time of laminar room admission and discharge, respectively.
Measured: The microbiota-derived metabolites were collected at the time of laminar room admission and 14 days post transplantation. Then the change in concentration between this two time-points were compared.
The Between-group Change for the Infection Rate
The infection rate is assessed as the number of diagnosed infections. The infection rate is determined through a comprehensive analysis of respiratory, blood, stool, and urine tests, with a positive result in any one of these tests leading to a diagnosis of an infection.
Measured: For the duration between the day of transplantation to 14 days of transplantation (approximate engraftment time)
The Within-group and Between-group Change for Gut Symptoms
Gut symptoms is assessed through the presence of diarrhoea in percentage. Diarrhoea was defined as the passage of more than 3 times loose stools daily.
Measured: The information on stool frequency and consistency was collected daily for the duration between the day of transplantation to 14 days post transplantation.
The Tolerability of Supplementing the Standard Polymeric Formula in the Targeted Population
The tolerability of supplementing the standard polymeric formula in the targeted population. This refers to the dropout rate related to intolerance.
Measured: For the duration between the baseline to 28 days post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Aug 2022
- Primary completion15 Jun 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460013
- Sponsor's protocol ID
- 2021-M05
- Status last verified
- May 2026
- First submitted
- 5 Jul 2022
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05460013
- Acronym / sponsor ID
- 2021-M05
- Conditions
- Haematological Malignancy
- Keywords
- Hematopoietic Stem Cell Transplantation, Oral Nutritional Supplements, Body Weight, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition is common after haematopoietic stem cell transplantation (HSCT), and is a well-known prognostic factor for survival. HSCT-associated treatments are metabolic and digestively intolerant, hence can induce a significant reduction in oral intake. Thus weight loss, as well as a reduction in serum albumin, and pre-albumin levels, are frequent following HSCT. Although the gut remains functional, sore mouth, mucositis, dysphagia, nausea, vomiting, and diarrhoea will inevitably hinder the implementation of enteral nutrition (EN), thus leading to a deficit between daily intake and requirement. Side effects of chemotherapy and antibiotics in combine will contribute to the alteration of intestinal flora on top of the existing gut symptoms, further impairing nutrient digestion and absorption.
Oral nutritional supplements (ONS) are foods for special medical purposes (FSMP) that are specially formulated for oral nutritional support. Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN, however, the data is sparse in China to support the safety of usage amongst this population. On the other side, what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT. It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms.
The study is a prospective study. All the participants will be recruited from a single research center (Renji Hospital). The participants will be randomized into two groups: traditional treatment or ONS. Ensure complete (Abbott), which contains soluble dietary fiber such as fructo-oligosaccharide (FOS) and inulin, will be served as the ONS for testing.
The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation. The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following: body weight, fat-free mass, circumference, handgrip test, and patient-generated global subjective assessment. The tolerability of supplementing ONS and its' effect on gut function as well as on infection rate is also of interest.
Detailed description
Standard Operating Procedures:
The study is located in Renji Hospital Stem Cell Transplant Unit, including Haematology Outpatient Department and Clinical Nutrition Department. All the patients aged between 18 and 75 years planned for HSCT and who are able to understand and sign an informed consent form are eligible for the study. The potential participants will be provided with the information sheet by the dietitian on the day of their outpatient pre-assessment visit. Each participant will be allocated with a study-specific code to protect their confidentiality. After recruitment, the participants will be asked to consume either the placebo control OR the ONS for testing, intended for supplementation for the duration of 7 days prior to HSCT admission. Anthropometry, biochemistry, and functional assessments are planned at four time points: before admission (baseline), the day of transplantation (D0), 14 days post-transplantation (D14) and 28 days post-transplantation (D28). In addition, nutritional intakes and gut assessments will be collected for the duration of the whole admission. If a subject is discharged home before D14 or D28, then these will be attempted at the appropriate time when the patient attended Haematology Outpatients for medical follow-up visits. Teleconsultation might be involved if the visit is not possible. All the data will be stored in an electronic database. It will be password protected with access only restricted to major investigators. All adverse events occurring within the trial will be collected at each visit for assessment of safety.
Sample Size Assessment:
A total number of 100 participants is determined necessary to demonstrate an effect. This sample size is designed to provide 85% power to detect a 1.2kg difference in body weight using an alpha=0.05(two-sided) to account for comparisons.
Plan for missing data:
A variable could be reported as missing by reasons possibly associated with logistic issues or participants declined to take the measurements. Strategy to minimize missing data includes setting up planning and time schedule in the Excel sheet to keep all the investigators notified.
Statistical Analysis Plan:
The demographic and clinical characteristics of patients will be summarized using descriptive statistics. Data analysis will be carried out using Statistical Analysis System (SAS) 9.4. Statistical analysis software. The mean or median change in continuous variables between the group by time points is assessed using t-test or Wilcoxon's rank sum test. Changes in categorical variables is assessed using Pearson chi-square or McNemar's test. Analysis of covariance or Analysis of variance might be applied as needed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: Traditional Control |
| Oral Nutritional Intervention | Experimental | Dietary Supplement: Oral Nutritional Supplement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned for HSCT
- No contraindications to enteral nutrition
- Able to consent
Key exclusion criteria (9 listed)
- Existing contraindications to enteral nutrition
- Existing infectious diarrhoea
- Had other malignancies
- Had gut surgery in a year
- Had used prebiotics or probiotics or synbiotic in a month
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 |
|---|---|---|
| Traditional ControlPlacebo control is a compounded made-up shake that is traditionally used by the Haematology ward to supplement patients receiving HSCT. The control provides an equivalent of 500kcals and 20.6g protein, 3.4g fiber per day. The participants will be randomly assigned to consume the control twice daily for the duration of 7 days prior to the admission to the day of discharge. | Dietary supplement | Placebo Control |
| Oral Nutritional SupplementAlso: Ensure Complete (Abbott)The product to be studied is a standard polymeric formula. It is intended to provide 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly presented in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants will be randomly assigned to consume the intervention twice a day for the duration of 7 days prior to the admission to the day of discharge. | Dietary supplement | Oral Nutritional Intervention |
Primary outcome
The Between-group Change for Body Weight
Time frame: It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two arms
It quantifies the difference in weight change between the groups. Body weight is assessed in kilograms.
11 secondary outcomes
The Within-group Change for Body Weight (Ensure)
Time frame: It measures the change in body weight within the Ensure group from baseline to three time points post-transplantation, namely the day of transplantation, 14 days post transplantation and 28 days post transplantation
The Within-group Change for Body Weight (Control)
Time frame: It measures the change in body weight within the control group from baseline to three time points post-transplantation, namely the day of transplantation, 14 days post transplantation and 28 days post transplantation
The Between-group and Within-group Change for Fat-free Mass
Time frame: The fat-free mass was measured at baseline and at 28 days post transplantation. Then the change from baseline to 28 days post transplantation were compared.
The Between-group and Within-group Change for Calf Circumference
Time frame: The calf circumference was measured at baseline, at the day of transplantation, 14 days post transplantation and 28 days post transplantation. Then the change from baseline to these three timepoints were compared.
It Measures the Between-group and Within-group Change for the Handgrip Test.
Time frame: The handgrip test was conducted at baseline, at the day of transplantation, 14 days post transplantation and 28 days post transplantation. Then the change from baseline to these three timepoints were compared.
The Within-group and Between-group Change for Patient-Generated Subjective Global Assessment
Time frame: PG-SGA was conducted at baseline and at 28 days post transplantation. Then the change in PG-SGA scores between these two timepoints were compared.
The Within-group and Between-group Change for Microbiota Diversity
Time frame: The stool samples were collected at the time of laminar room admission and 14 days post transplantation. Then the change in alpha-diversity index between this two time-points were compared.
The Within-group Change for Microbiota-derived Metabolites in Urine
Time frame: The microbiota-derived metabolites were collected at the time of laminar room admission and 14 days post transplantation. Then the change in concentration between this two time-points were compared.
The Between-group Change for the Infection Rate
Time frame: For the duration between the day of transplantation to 14 days of transplantation (approximate engraftment time)
The Within-group and Between-group Change for Gut Symptoms
Time frame: The information on stool frequency and consistency was collected daily for the duration between the day of transplantation to 14 days post transplantation.
The Tolerability of Supplementing the Standard Polymeric Formula in the Targeted Population
Time frame: For the duration between the baseline to 28 days post transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement in people with Haematological Malignancy, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 11 May 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 China. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Between-group Change for Body Weight (time frame: It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two arms). 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 11 May 2026.