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Completed

NCT Number: NCT04111471

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

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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotics

Dietary Supplement

Enrolled patients will receive 10 grams of inulin daily for 21 days

Other names: inulin

Placebos

Dietary Supplement

Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days

Other names: Maltodextrin

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2019
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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