- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111471
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
Conditions
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
- Name: Alexander M Newman, MD
- Phone Number: 3122274080
- Email: anewman@luriechildrens.org
Study Contact Backup
- Name: Mehreen Arshad, MD
- Phone Number: 3122274080
- Email: marshad@luriechildrens.org
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:
- 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
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:
|
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:
|
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
Keywords
Additional Relevant MeSH Terms
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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