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

February 20, 2020 updated by: Alexander Newman, Ann & Robert H Lurie Children's Hospital of Chicago

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

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 Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
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)
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
Time Frame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
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
Time Frame: Change in baseline SCFA levels in stool at 100 days after transplant
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
Time Frame: Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander M Newman, MD, Lurie Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

July 1, 2021

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)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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