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

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

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

Study Overview

• Status: Completed
• Conditions: Microbial Colonization
• Intervention / Treatment: Dietary supplement: Placebos; Dietary supplement: Prebiotics

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; 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)	Dietary supplement: Placebos; Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days; Other Names: Maltodextrin
Experimental: Prebiotic (Inulin) Arm; 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)	Dietary supplement: Prebiotics; Enrolled patients will receive 10 grams of inulin daily for 21 days; Other Names: inulin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Mehreen M Arshad, MD, Lurie Children's/Northwestern

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): November 18, 2024

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; Prebiotic
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2019-2801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No