N/A
N=100
Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation
Haematological Malignancy
Bottom Line
View on ClinicalTrials.gov: NCT05460013 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
May 2026
Primary outcome: Primary: The Between-group Change for Body Weight — -4.0; -3.4 kilogram — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Traditional Control (Dietary_supplement); Oral Nutritional Supplement (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RenJi Hospital
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Between-group Change for Body Weight |
-4.0; -3.4 | 0.24 |
| SECONDARY The Within-group Change for Body Weight (Ensure) |
0.77; -2.20; -4.03 | 0.04 sig |
| SECONDARY The Within-group Change for Body Weight (Control) |
0.70; -2.26; -3.42 | 0.03 sig |
| SECONDARY The Between-group and Within-group Change for Fat-free Mass |
-2.3; -1.9 | 0.24 |
| SECONDARY The Between-group and Within-group Change for Calf Circumference |
-1.5; -1.5; -2.3; -3.5; -1.9; -1.9 | 0.9 |
| SECONDARY It Measures the Between-group and Within-group Change for the Handgrip Test. |
-3.7; -4.3; -6.0; -5.7; -3.7; -4.9 | 0.5 |
| SECONDARY The Within-group and Between-group Change for Patient-Generated Subjective Global Assessment |
5.0; 3.0 | 0.2 |
| SECONDARY The Within-group and Between-group Change for Microbiota Diversity |
-20.5; -17.5; -1.0; -0.9; 0.3; 0.3 | <0.001 sig |
| SECONDARY The Within-group Change for Microbiota-derived Metabolites in Urine |
2965.4; 3016.9; 3080.4; 3047.5; 4.7; 4.1 | 0.89 |
| SECONDARY The Between-group Change for the Infection Rate |
28; 24; 5; 3; 25; 19 | 0.5 |
| SECONDARY The Within-group and Between-group Change for Gut Symptoms |
37; 29 | 0.4 |
| SECONDARY The Tolerability of Supplementing the Standard Polymeric Formula in the Targeted Population |
1; 0 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Planned for HSCT
- No contraindications to enteral nutrition
- Able to consent
Exclusion Criteria
- 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)
- Pregnancy or lactation
- Had an allergy, or intolerance to ingredients of dietary supplements
- Judged to be unsafe to tolerate fiber
Data sourced from ClinicalTrials.gov (NCT05460013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.