Trial Outcomes & Findings for Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation (NCT NCT05460013)
NCT ID: NCT05460013
Last Updated: 2026-05-11
Results Overview
It quantifies the difference in weight change between the groups. Body weight is assessed in kilograms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two arms
Results posted on
2026-05-11
Participant Flow
The date of the recruitment period was between Aug 2022 and Dec 2024. The study was based on a single-centre at Ren Ji hospital.
In total, 104 patients were screened, but four participants were excluded from the study before assignment. One patient in the ONS group was discontinued due to non-compliance secondary to psychiatric disease. Three patients in the control group were discontinued due to death, non-compliance or sudden clinical deterioration.
Participant milestones
| Measure |
Oral Nutritional Intervention
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
Day of Transplantation (D0)
STARTED
|
53
|
47
|
|
Day of Transplantation (D0)
Received HSCT
|
53
|
47
|
|
Day of Transplantation (D0)
COMPLETED
|
52
|
46
|
|
Day of Transplantation (D0)
NOT COMPLETED
|
1
|
1
|
|
14 Days of Transplantation (D14)
STARTED
|
52
|
46
|
|
14 Days of Transplantation (D14)
COMPLETED
|
51
|
45
|
|
14 Days of Transplantation (D14)
NOT COMPLETED
|
1
|
1
|
|
28 Days of Transplantation (D28)
STARTED
|
51
|
45
|
|
28 Days of Transplantation (D28)
COMPLETED
|
44
|
36
|
|
28 Days of Transplantation (D28)
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Oral Nutritional Intervention
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
Day of Transplantation (D0)
ons intolerance
|
1
|
0
|
|
Day of Transplantation (D0)
graft failture
|
0
|
1
|
|
14 Days of Transplantation (D14)
Death
|
0
|
1
|
|
14 Days of Transplantation (D14)
Withdrawal by Subject
|
1
|
0
|
|
28 Days of Transplantation (D28)
Withdrawal by Subject
|
4
|
1
|
|
28 Days of Transplantation (D28)
Lost to Follow-up
|
3
|
8
|
Baseline Characteristics
Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Placebo Control
n=47 Participants
Traditional Control: 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 Intervention
n=53 Participants
Oral Nutritional Supplement: 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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=44 Participants
|
55 years
n=10 Participants
|
55 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=44 Participants
|
28 Participants
n=10 Participants
|
49 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=44 Participants
|
25 Participants
n=10 Participants
|
51 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
47 Participants
n=44 Participants
|
53 Participants
n=10 Participants
|
100 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
China
|
47 participants
n=44 Participants
|
53 participants
n=10 Participants
|
100 participants
n=30 Participants
|
|
Body weight
|
65.4 kilogram
STANDARD_DEVIATION 10.7 • n=44 Participants
|
64.0 kilogram
STANDARD_DEVIATION 10.3 • n=10 Participants
|
64.6 kilogram
STANDARD_DEVIATION 10.4 • n=30 Participants
|
|
Fat free mass
|
48.2 kilogram
n=44 Participants
|
44.8 kilogram
n=10 Participants
|
46.7 kilogram
n=30 Participants
|
|
Calf circumference
|
35.7 centimeter
STANDARD_DEVIATION 3.0 • n=44 Participants
|
34.8 centimeter
STANDARD_DEVIATION 3.1 • n=10 Participants
|
35.1 centimeter
STANDARD_DEVIATION 3.0 • n=30 Participants
|
|
Handgrip
|
29.5 kilogram
n=44 Participants
|
24.0 kilogram
n=10 Participants
|
25.7 kilogram
n=30 Participants
|
|
Patient generated subjective global assessment
|
3.0 scores on a scale
n=44 Participants
|
3.0 scores on a scale
n=10 Participants
|
3.0 scores on a scale
n=30 Participants
|
PRIMARY outcome
Timeframe: It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two armsPopulation: The number of participants analyzed is consistent with the numbers provided in the D28 row in the participant flow module.
It quantifies the difference in weight change between the groups. Body weight is assessed in kilograms.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=44 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=36 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Between-group Change for Body Weight
|
-4.0 kilogram
Standard Deviation 2.4
|
-3.4 kilogram
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 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 transplantationPopulation: The reduction in the number of participants analyzed is due to some missing data. However, this does not mean that all measured data are missing at the measurement time points. It only indicates that body weight could not be measured (for example, the participants were required to stay in bed, making weight measurement impossible).
It measures the within-group change for body weight in the ensure group. Body weight is assessed in kilograms
Outcome measures
| Measure |
Oral Nutritional Intervention
n=52 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Within-group Change for Body Weight (Ensure)
at day of transplantation
|
0.77 kilogram
Standard Deviation 2.54
|
—
|
|
The Within-group Change for Body Weight (Ensure)
14 days post transplantation
|
-2.20 kilogram
Standard Deviation 2.78
|
—
|
|
The Within-group Change for Body Weight (Ensure)
28 days post transplantation
|
-4.03 kilogram
Standard Deviation 2.42
|
—
|
SECONDARY outcome
Timeframe: 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 transplantationPopulation: The reduction in the number of participants analyzed is due to some missing data. However, this does not mean that all measured data are missing at the measurement time points. It only indicates that body weight could not be measured (for example, the participants were required to stay in bed, making weight measurement impossible).
It measures the within-group change for body weight in the control group. Body weight is assessed in kilograms
Outcome measures
| Measure |
Oral Nutritional Intervention
n=46 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Within-group Change for Body Weight (Control)
at day of transplantation
|
0.70 kilogram
Standard Deviation 1.93
|
—
|
|
The Within-group Change for Body Weight (Control)
14 days of transplantation
|
-2.26 kilogram
Standard Deviation 2.00
|
—
|
|
The Within-group Change for Body Weight (Control)
28 days of transplantation
|
-3.42 kilogram
Standard Deviation 2.12
|
—
|
SECONDARY outcome
Timeframe: 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.Population: The number differs from the previously stated overall number because three patients in the testing group were removed from the analysis due to missing baseline measurements and excessive oedema.
It measures the between-group and within-group change for Fat-free mass. Fat-free mass is assessed in kilograms.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=41 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=36 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Between-group and Within-group Change for Fat-free Mass
|
-2.3 kilogram
Interval -3.6 to -1.1
|
-1.9 kilogram
Interval -3.5 to -0.8
|
SECONDARY outcome
Timeframe: 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.Population: Numbers analyzed in each row vary due to missing data or loss to follow-up.
It measures the between-group and within-group change for calf circumference. Calf circumference is assessed in centimeters.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=52 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=46 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Between-group and Within-group Change for Calf Circumference
at day of transplantation
|
-1.5 centimeter
Interval -3.0 to 0.0
|
-1.5 centimeter
Interval -3.0 to -0.4
|
|
The Between-group and Within-group Change for Calf Circumference
14 days of transplantation
|
-2.3 centimeter
Interval -3.6 to -1.0
|
-3.5 centimeter
Interval -4.4 to -2.4
|
|
The Between-group and Within-group Change for Calf Circumference
28 days of transplantation
|
-1.9 centimeter
Interval -3.0 to -0.5
|
-1.9 centimeter
Interval -2.8 to -0.7
|
SECONDARY outcome
Timeframe: 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.Population: Numbers analyzed in each row vary due to missing data or loss to follow-up.
It measures the between-group and within-group change for the handgrip test. Handgrip test is assessed in kilograms.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=52 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=46 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
It Measures the Between-group and Within-group Change for the Handgrip Test.
at day of transplantation
|
-3.7 kilogram
Standard Deviation 4.3
|
-4.3 kilogram
Standard Deviation 4.6
|
|
It Measures the Between-group and Within-group Change for the Handgrip Test.
14 days of transplantation
|
-6.0 kilogram
Standard Deviation 5.2
|
-5.7 kilogram
Standard Deviation 6.1
|
|
It Measures the Between-group and Within-group Change for the Handgrip Test.
28 days of transplantation
|
-3.7 kilogram
Standard Deviation 4.1
|
-4.9 kilogram
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=44 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=36 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Within-group and Between-group Change for Patient-Generated Subjective Global Assessment
|
5.0 score on a scale
Interval 1.0 to 9.0
|
3.0 score on a scale
Interval 1.0 to 5.8
|
SECONDARY outcome
Timeframe: 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.Population: The study analyzed 63 pre- and post-transplant stool samples. The sobs, shannon and simpson index included in the outcome measure table below are all secondary to the alpha diversity index. They don't differ in their units of measure, hence are included in the same table.
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.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=30 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=33 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Within-group and Between-group Change for Microbiota Diversity
Shannon
|
-1.0 α-diversity indices
Standard Deviation 0.2
|
-0.9 α-diversity indices
Standard Deviation 0.2
|
|
The Within-group and Between-group Change for Microbiota Diversity
Sobs
|
-20.5 α-diversity indices
Standard Deviation 5.8
|
-17.5 α-diversity indices
Standard Deviation 1.2
|
|
The Within-group and Between-group Change for Microbiota Diversity
Simpson
|
0.3 α-diversity indices
Standard Deviation 0.1
|
0.3 α-diversity indices
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 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 diversity is assessed through urine samples. For practical considerations, urine samples were collected at the time of laminar room admission and discharge, respectively.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=30 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=33 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
benzenoids (post)
|
5.8 micromolar per liter
Interval 4.4 to 7.9
|
4.7 micromolar per liter
Interval 3.3 to 7.1
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
benzoic acids (pre)
|
111.2 micromolar per liter
Interval 65.3 to 225.9
|
134.9 micromolar per liter
Interval 92.0 to 225.2
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
benzoic acids (post)
|
57.0 micromolar per liter
Interval 35.8 to 88.2
|
51.1 micromolar per liter
Interval 40.9 to 67.8
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
bile acids (pre)
|
54.8 micromolar per liter
Interval 2.9 to 102.6
|
99.1 micromolar per liter
Interval 2.1 to 102.3
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
bile acids (post)
|
100.5 micromolar per liter
Interval 54.4 to 102.5
|
100.9 micromolar per liter
Interval 59.8 to 102.5
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
carbohydrates (pre)
|
1728.4 micromolar per liter
Interval 1215.2 to 2395.2
|
1159.5 micromolar per liter
Interval 925.3 to 1620.9
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
carbohydrates (post)
|
4102.9 micromolar per liter
Interval 3206.8 to 5021.6
|
3472.0 micromolar per liter
Interval 2556.7 to 4796.8
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
amino acids (pre)
|
2965.4 micromolar per liter
Interval 2181.1 to 3562.0
|
3016.9 micromolar per liter
Interval 2487.1 to 3330.5
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
amino acids (post)
|
3080.4 micromolar per liter
Interval 2293.6 to 3588.6
|
3047.5 micromolar per liter
Interval 2494.9 to 3710.4
|
|
The Within-group Change for Microbiota-derived Metabolites in Urine
benzenoids (pre)
|
4.7 micromolar per liter
Interval 3.2 to 5.7
|
4.1 micromolar per liter
Interval 3.2 to 5.4
|
SECONDARY outcome
Timeframe: For the duration between the day of transplantation to 14 days of transplantation (approximate engraftment time)Population: The count of participants below represents the number of participants with infection
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.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=50 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=45 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Between-group Change for the Infection Rate
respiratory infection
|
28 Participants
|
24 Participants
|
|
The Between-group Change for the Infection Rate
blood infection
|
5 Participants
|
3 Participants
|
|
The Between-group Change for the Infection Rate
fecal infection
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: The information on stool frequency and consistency was collected daily for the duration between the day of transplantation to 14 days post transplantation.Population: The count of participants below represents the number of participants with diarrhoea (defined as the passage of more than four times loose stools per day)
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.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=50 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=45 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
The Within-group and Between-group Change for Gut Symptoms
|
37 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: For the duration between the baseline to 28 days post transplantationPopulation: Overall, there is only one participant who has dropped out in relation to intolerance. The patient belongs to the testing group.
The tolerability of supplementing the standard polymeric formula in the targeted population. This refers to the dropout rate related to intolerance.
Outcome measures
| Measure |
Oral Nutritional Intervention
n=50 Participants
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
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Placebo Control
n=45 Participants
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
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|---|---|---|
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The Tolerability of Supplementing the Standard Polymeric Formula in the Targeted Population
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1 Participants
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0 Participants
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Adverse Events
Oral Nutritional Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Oral Nutritional Intervention
n=53 participants at risk
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=47 participants at risk
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
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Blood and lymphatic system disorders
Death before transplantation
|
0.00%
0/53 • The adverse event data were collected for the duration between baseline and 28 days post transplantation.
Throughout the trial, 1 patient dropped out due to intolerance. Regarding all-cause mortality, 1 screened patient in the control group died before transplantation due to medical deterioration; the death was judged irrelevant as the intervention had not been administered. Another patient died in the laminar room due to sudden deterioration, and the medical team deemed the death unrelated to the intervention.
|
2.1%
1/47 • The adverse event data were collected for the duration between baseline and 28 days post transplantation.
Throughout the trial, 1 patient dropped out due to intolerance. Regarding all-cause mortality, 1 screened patient in the control group died before transplantation due to medical deterioration; the death was judged irrelevant as the intervention had not been administered. Another patient died in the laminar room due to sudden deterioration, and the medical team deemed the death unrelated to the intervention.
|
|
Blood and lymphatic system disorders
Death during transplantation
|
0.00%
0/53 • The adverse event data were collected for the duration between baseline and 28 days post transplantation.
Throughout the trial, 1 patient dropped out due to intolerance. Regarding all-cause mortality, 1 screened patient in the control group died before transplantation due to medical deterioration; the death was judged irrelevant as the intervention had not been administered. Another patient died in the laminar room due to sudden deterioration, and the medical team deemed the death unrelated to the intervention.
|
2.1%
1/47 • The adverse event data were collected for the duration between baseline and 28 days post transplantation.
Throughout the trial, 1 patient dropped out due to intolerance. Regarding all-cause mortality, 1 screened patient in the control group died before transplantation due to medical deterioration; the death was judged irrelevant as the intervention had not been administered. Another patient died in the laminar room due to sudden deterioration, and the medical team deemed the death unrelated to the intervention.
|
Other adverse events
| Measure |
Oral Nutritional Intervention
n=53 participants at risk
The product is a standard polymeric formula. It provided 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly present in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants were randomly assigned to consume the intervention twice a day, starting 7 days prior to HSCT admission and continuing until discharge.
|
Placebo Control
n=47 participants at risk
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 were randomly assigned to consume the control twice daily, starting 7 days prior to HSCT admission and continuing until discharge.
|
|---|---|---|
|
Gastrointestinal disorders
Intolerance
|
1.9%
1/53 • The adverse event data were collected for the duration between baseline and 28 days post transplantation.
Throughout the trial, 1 patient dropped out due to intolerance. Regarding all-cause mortality, 1 screened patient in the control group died before transplantation due to medical deterioration; the death was judged irrelevant as the intervention had not been administered. Another patient died in the laminar room due to sudden deterioration, and the medical team deemed the death unrelated to the intervention.
|
0.00%
0/47 • The adverse event data were collected for the duration between baseline and 28 days post transplantation.
Throughout the trial, 1 patient dropped out due to intolerance. Regarding all-cause mortality, 1 screened patient in the control group died before transplantation due to medical deterioration; the death was judged irrelevant as the intervention had not been administered. Another patient died in the laminar room due to sudden deterioration, and the medical team deemed the death unrelated to the intervention.
|
Additional Information
Dr. Renying Xu
Ren Ji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Phone: 6838 3335
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place