Status:
COMPLETED
The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Microbial Colonization
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
Detailed Description
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 1...
Eligibility Criteria
Inclusion
- Age 2-18 years
- Allogeneic Stem Cell transplant
- Myeloablative therapy
- Inpatient at Lurie Children's Hospital
Exclusion
- 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
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04111471
Start Date
October 31 2019
End Date
November 18 2024
Last Update
November 21 2024
Active Locations (1)
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1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611