Clinical trial NCT04111471: The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients
Official title: The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Keywords: Microbiome
Prebiotic
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 2-18 years
2. Allogeneic Stem Cell transplant
3. Myeloablative therapy
4. Inpatient at Lurie Children's Hospital

Exclusion Criteria:

1. Previous Hematopoietic Stem Cell Transplant
2. Autologous Stem Cell Transplant
3. Reduced Intensity Conditioning used for transplant
4. History of ulcerative colitis, Crohn's disease, irritable bowel syndrome, celiac disease
5. History of Type 1 or Type 2 Diabetes Mellitus
6. Previous abdominal surgery necessitating the use of an ostomy
7. G-tube dependence
8. Nasal gastric/oral gastric tube dependence prior to starting the conditioning process
9. Graft vs host disease prior to enrollment at any site
10. 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

Primary outcomes:
measure: Change in alpha and beta bacterial diversity measures in stool
timeFrame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
measure: Change in Short Chain Fatty Acid (SCFA) levels in stool
timeFrame: Change in baseline SCFA levels in stool at 100 days after transplant
Secondary outcomes:
measure: Bacterial Resistance genes in stool
timeFrame: Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Lurie Children's/Northwestern
name: Mehreen M Arshad, MD
role: PRINCIPAL_INVESTIGATOR
References: