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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04111471
Other study ID # 2019-2801
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 31, 2019
Est. completion date July 2021

Study information

Verified date February 2020
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact Alexander M Newman, MD
Phone 3122274080
Email anewman@luriechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Prebiotics
Enrolled patients will receive 10 grams of inulin daily for 21 days
Placebos
Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days

Locations

Country Name City State
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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