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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111471
• Other study ID #: 2019-2801
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

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