The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients

Study Overview
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Brief Summary
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Children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. They will start taking the product seven days before transplant starts until 14 days after transplant. Stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. Stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. They will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. From 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). No product (inulin or placebo) will be given during this time frame. The study period ends 100 days after transplant.

Official Title
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The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients

Conditions
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Microbial Colonization

Intervention / Treatment
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* Drug: Prebiotics
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 2-18 years Allogeneic Stem Cell transplant Myeloablative therapy Inpatient at Lurie Children's Hospital Exclusion Criteria: Previous Hematopoietic Stem Cell Transplant Autologous Stem Cell Transplant Reduced Intensity Conditioning used for transplant History of ulcerative colitis, Crohn's disease, irritable bowel syndrome, celiac disease History of Type 1 or Type 2 Diabetes Mellitus Previous abdominal surgery necessitating the use of an ostomy G-tube dependence Nasal gastric/oral gastric tube dependence prior to starting the conditioning process Graft vs host disease prior to enrollment at any site Children under 2 years of age - literature shows that the microbiome is still developing in children under two years of age, and this development may skew results

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Qualified patients that are admitted to Lurie Children's Hospital and agree to participate will either be randomized to receive the placebo or prebiotic, inulin. Randomization will occur 1:1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>20 patients will receive 5.6 g of placebo product (maltodextrin) daily for a total of 21 days (7 days before and until 2 weeks after transplant) | Drug: Placebos<br>* Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days<br>* Other names: Maltodextrin;|
| Experimental: Prebiotic (Inulin) Arm<br>20 patients will receive 10 g of inulin product daily for a total of 21 days (7 days before and until 2 weeks after transplant) | Drug: Prebiotics<br>* Enrolled patients will receive 10 grams of inulin daily for 21 days<br>* Other names: inulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alpha and beta bacterial diversity measures in stool | Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing hematopoietic stem cell transplant | Change of baseline alpha and beta bacterial diversity at 100 days after transplant | 
| Change in Short Chain Fatty Acid (SCFA) levels in stool | Compare the effect of oral inulin vs. placebo on SCFA levels in the stool of children undergoing hematopoietic stem cell transplant | Change in baseline SCFA levels in stool at 100 days after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Resistance genes in stool | Determine the impact of inulin intake vs. placebo on the prevalence of genes associated with antibiotic resistance of children undergoing hematopoietic stem cell transplant | Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Prebiotic