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Prebiotics, the gastrointestinal microbiome and clinical outcomes post allogeneic stem cell transplantation

Tolerance of prebiotic containing enteral nutrition post allogeneic stem cell transplantation.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000832875
Enrollment
30
Registered
2021-06-30
Start date
2021-10-15
Completion date
2022-05-18
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients undergoing allogeneic stem cell transplantation frequently require enteral (nasogastric) feeding however the best formula to provide is unclear. Some research has found that the type and diversity of gastrointestinal bacteria (microbiome) may be linked to differences in health outcomes after transplant. Prebiotic fibre may assist in increasing the diversity of the microbiome and the abundance of beneficial bacteria. The aim of this pilot study is to investigate the use of a prebiotic fibre containing enteral feed and its effect on the microbiome and health outcomes after transplantation. This study will recruit 10 participants who are receiving the standard fibre free enteral feed and 20 participants to receive a prebiotic containing feed. Data on clinical outcomes will be collected as well as stool and blood samples before transplant and 2 weeks post, to assess changes in the microbiome. This research will help in improving care for future patients by increasing knowledge on the best enteral feed formula to provide after stem cell transplantation.

Interventions

This study aims to compare enteral feed tolerance, microbial diversity, microbiome composition and clinical outcomes between patients who receive standard non fibre enteral nutrition (EN) vs prebiotic containing EN post allogeneic stem cell transplantation. Patients will be allocated to standard or prebiotic EN consecutively (first 10 patients recruited will be allocated to standard care, last 20 patients to intervention). Nutrition support is provided while participants are inpatients for stem

This study aims to compare enteral feed tolerance, microbial diversity, microbiome composition and clinical outcomes between patients who receive standard non fibre enteral nutrition (EN) vs prebiotic containing EN post allogeneic stem cell transplantation. Patients will be allocated to standard or prebiotic EN consecutively (first 10 patients recruited will be allocated to standard care, last 20 patients to intervention). Nutrition support is provided while participants are inpatients for stem cell transplantation. Conditioning pre transplant will be as per usual care, for 5-12 days depending on regimen. Participants in both groups will commence EN, increase the feeding rate and cease feeding as per usual care. This includes commencing EN on day +1 post transplant at 30ml/hr of continuous feeding via a 10-12fr nasogastric tube, increasing to 50ml/hr when oral intake declines to <50% of meals and increasing to goal EN (providing 100% of estimated requirements) if oral intake is minimal. If EN ceases due to intolerance and oral intake is poor, patients will be converted to parenteral nutrition (PN). Both EN and PN will cease once oral intake is >50% meals and 2 high protein drinks/ day post neutrophil engraftment. During provision of nutrition support patients will be provided with high protein high energy meals and snacks and encouraged to continue oral intake if tolerated. Participants allocated to receive the prebiotic EN will receive a polymeric ready to hang formula (1.2kcal/ml, 63g protein,15g fibre /L) containing inulin, oligofructose, arabic gum, soy polysaccharides, cellulose and resistant starch, instead of the usual non fibre EN formula. Tolerance of EN will be monitored and if poor, participants will be changed to PN as per standard care. Adherance to the intervention is monitored by review of the participants fluid balance charts and documenting the amount of prescribed feed actually received. Stool samples will be collected pre conditioning, post conditioning and at day 12-18 post transplant (peri engraftment). Blood samples will be collected post conditioning and at two weeks post transplant. Clinical outcomes will be collected during the transplant admission and at day 100. Oral intake will be monitored for three days pre conditioning (participants will complete a paper food diary or record intake in the 'Easy diet diary' app) and for two weeks post transplant while inpatients (paper diary).

Sponsors

Royal Brisbane and Womens Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged 18 or older undergoing allogeneic myeloablative or reduced intensity myeloablative allogeneic stem cell transplantation at the Royal Brisbane and Womens Hospital who can provide written informed consent.

Exclusion criteria

Patients already enrolled on a GVHD prevention study, hepatitis B, hepatitis C or HIV infection or intolerance or allergy to any ingredient in the enteral feed.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026