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

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Prebiotics; Dietary Supplement: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04111471

2019-2801

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 5 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebos

Prebiotic (Inulin) Arm

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Prebiotics