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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control | Placebo Comparator |
| |
| Oral Nutritional Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Control | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Between-group Change for Body Weight | It quantifies the difference in weight change between the groups. Body weight is assessed in kilograms. | It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two arms |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200124 | China |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day of Transplantation (D0) |
|
| ||||||||||||||||||||||||
| 14 Days of Transplantation (D14) |
| |||||||||||||||||||||||||
| 28 Days of Transplantation (D28) |
|
The participants were all Chinese adults recruited from a single centre at Ren Ji Hospital in Shanghai.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Control | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Between-group Change for Body Weight | It quantifies the difference in weight change between the groups. Body weight is assessed in kilograms. | The number of participants analyzed is consistent with the numbers provided in the D28 row in the participant flow module. | Posted | Mean | Standard Deviation | kilogram | It compares the change in body weight between two timepoints ( at baseline and at 28 days post transplantation) between two arms |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death before transplantation | Blood and lymphatic system disorders | Non-systematic Assessment | 1 screened patient in the control group died before transplantation due to sudden medical deterioration; the death was judged irrelevant as the intervention had not been administered. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerance | Gastrointestinal disorders | Non-systematic Assessment | 1 patient dropped out due to intolerance, which was judged relevant to the testing product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Renying Xu | Ren Ji Hospital affiliated to Shanghai Jiao Tong University School of Medicine | 6838 3335 | xurenying7465@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2022 | Jan 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2022 | Jan 12, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| Oral Nutritional Supplement | Dietary 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. |
|
|
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | For the duration between the baseline to 28 days post transplantation |
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| NOT COMPLETED |
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| BG001 | Oral Nutritional Intervention | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kilogram |
|
| Fat free mass | Median | Inter-Quartile Range | kilogram |
|
| Calf circumference | Mean | Standard Deviation | centimeter |
|
| Handgrip | Median | Inter-Quartile Range | kilogram |
|
| Patient generated subjective global assessment | Median | Inter-Quartile Range | scores on a scale |
|
| OG001 | 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. |
|
|
|
| Secondary | 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 | 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). | Posted | Mean | Standard Deviation | kilogram | 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 |
|
|
|
|
| Secondary | 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 | 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). | Posted | Mean | Standard Deviation | kilogram | 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 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | kilogram | 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. |
|
|
|
|
| Secondary | 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. | Numbers analyzed in each row vary due to missing data or loss to follow-up. | Posted | Median | Inter-Quartile Range | centimeter | 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. |
|
|
|
|
| Secondary | 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. | Numbers analyzed in each row vary due to missing data or loss to follow-up. | Posted | Mean | Standard Deviation | kilogram | 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. |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 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. |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | α-diversity indices | 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. |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | micromolar per liter | 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. |
|
|
|
|
| Secondary | 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. | The count of participants below represents the number of participants with infection | Posted | Count of Participants | Participants | For the duration between the day of transplantation to 14 days of transplantation (approximate engraftment time) |
|
|
|
|
| Secondary | 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. | 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) | Posted | Count of Participants | Participants | The information on stool frequency and consistency was collected daily for the duration between the day of transplantation to 14 days post transplantation. |
|
|
|
|
| Secondary | 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. | Overall, there is only one participant who has dropped out in relation to intolerance. The patient belongs to the testing group. | Posted | Count of Participants | Participants | No | For the duration between the baseline to 28 days post transplantation |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 1 |
| 53 |
| EG001 | 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. | 2 | 47 | 2 | 47 | 0 | 47 |
|
| Death during transplantation | Blood and lymphatic system disorders | Non-systematic Assessment | 1 patient died in the laminar room due to sudden medical deterioration(septic shock), and the medical team deemed the death unrelated to the intervention. |
|
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 28 days post transplantation |
|
|
P-value for weight on 14 days of transplantation.
| Superiority |
| t-test, 2 sided | <0.001 | P-value for weight on 28 days of transplantation. | Superiority |
|
| 28 days of transplantation |
|
|
P-value for weight on 14 days of transplantation
| Superiority |
| t-test, 2 sided | <0.001 | P-value for weight on 28 days of transplantation | Superiority |
| <0.001 |
| Superiority |
| This statistical analysis compares the differences within the control group | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| 14 days of transplantation |
|
|
| 28 days of transplantation |
|
|
| 0.02 |
| Superiority |
| This measures the statistical significance between the two groups at D28. | Wilcoxon (Mann-Whitney) | 0.8 | Superiority |
| This compares the difference of calf circumference within the control group at D0. | Wilcoxon (Mann-Whitney) | 0.001 | Superiority |
| This compares the difference in calf circumference within the control group at D14. | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| This compares the difference in calf circumference within the control group at D28. | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| This compares the difference in calf circumference within the testing group at D0. | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| This compares the difference in calf circumference within the testing group at D14. | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| This compares the difference in calf circumference within the testing group at D28. | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| 14 days of transplantation |
|
|
| 28 days of transplantation |
|
|
| t-test, 2 sided |
| 0.8 |
| Superiority |
| This measures the statistical significance of the change in handgrip test between the two groups at D28. | t-test, 2 sided | 0.3 | Superiority |
| This measures the statistical significance of the change in handgrip test within the control group at D0. | t-test, 2 sided | <0.001 | Superiority |
| This measures the statistical significance of the change in handgrip test within the control group at D14. | t-test, 2 sided | <0.001 | Superiority |
| This measures the statistical significance of the change in handgrip test within the control group at D28. | t-test, 2 sided | <0.001 | Superiority |
| This measures the statistical significance of the change in handgrip test within the testing group at D0. | t-test, 2 sided | <0.001 | Superiority |
| This measures the statistical significance of the change in handgrip test within the testing group at D14. | t-test, 2 sided | <0.001 | Superiority |
| This measures the statistical significance of the change in handgrip test within the testing group at D28. | t-test, 2 sided | <0.001 | Superiority |
| Wilcoxon (Mann-Whitney) |
| <0.001 |
| Superiority |
| This compares the statistical significance of the change in PG-SGA within the testing group at D28. | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| Simpson |
|
| Superiority |
α-diversity indices were used to analyze the difference with the ensure group (post vs. pre). |
| t-test, 2 sided | >0.01 | Superiority | α-diversity indices were used to analyze the difference between groups before transplantation (ensure pre VS. control pre). |
| t-test, 2 sided | >0.01 | Superiority | α-diversity indices were used to analyze the post-transplantation microbial diversity between groups (ensure post vs. control post). |
| benzenoids (pre) |
|
| benzenoids (post) |
|
| benzoic acids (pre) |
|
| benzoic acids (post) |
|
| bile acids (pre) |
|
| bile acids (post) |
|
| carbohydrates (pre) |
|
| carbohydrates (post) |
|
| 0.06 |
| Superiority |
| analyze the differences in benzenoids within the control groups（post vs. pre). | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| analyze the differences in bile acids within the control groups（post vs. pre) | Wilcoxon (Mann-Whitney) | 0.12 | Superiority |
| analyze the differences in carbohydrates within the control groups（post vs. pre) | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| analyze the differences in amino acids within the FSMP groups（post vs. pre) | Wilcoxon (Mann-Whitney) | 0.89 | Superiority |
| analyze the differences in benzenoids within the FSMP groups（post vs. pre) | Wilcoxon (Mann-Whitney) | 0.06 | Superiority |
| analyze the differences in benzoic acids within the FSMP groups（post vs. pre) | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| analyze the differences in bile acids within the FSMP groups（post vs. pre) | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| analyze the differences in carbohydrates within the FSMP groups（post vs. pre) | Wilcoxon (Mann-Whitney) | <0.001 | Superiority |
| fecal infection |
|
| 0.4 |
| Superiority |
| The between-group difference in fecal infection | Chi-squared | 0.3 | Superiority |