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Prebiotic

Prebiotic (Inulin) Arm for Microbial Colonization

N/A
Waitlist Available
Led By Alexander M Newman, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
Awards & highlights

Study Summary

This trial will test whether inulin, a prebiotic, can help reduce antibiotic resistance in the gut microbiota of children undergoing hematopoietic stem cell transplantation (HSCT).

Eligible Conditions
  • Microbial Colonization

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Short Chain Fatty Acid (SCFA) levels in stool
Change in alpha and beta bacterial diversity measures in stool
Secondary outcome measures
Bacterial Resistance genes in stool

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Prebiotic (Inulin) ArmExperimental Treatment1 Intervention
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)
Group II: Placebo ArmPlacebo Group1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inulin
FDA approved

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
256 Previous Clinical Trials
5,187,840 Total Patients Enrolled
Alexander M Newman, MDPrincipal InvestigatorLurie Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients
Alexander Newman 2019. "The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04111471.
All > Microbiome
~7 spots leftby Apr 2025
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