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This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | 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) |
|
| Prebiotic (Inulin) Arm | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotics | Dietary Supplement | Enrolled patients will receive 10 grams of inulin daily for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehreen M Arshad, MD | Lurie Children's/Northwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D007444 | Inulin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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Qualified patients that are admitted to Lurie Children's Hospital and agree to participate will either be randomized to receive the placebo or prebiotic, inulin. Randomization will occur 1:1
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Participants will be randomized by an independent statistician based on patient enrollment number (LCH 001- LCH 040). Randomization will be 1:1. The statistician will randomly assort LCH 001-020 into Inulin/Placebo and LCH 021- LCH 040 into Inulin/placebo. This will ensure that an equal number of enrolled participants will be in each arm at 20 patients, and then again at anticipated full 40 patients
| Placebos | Dietary Supplement | Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days |
|
|
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D005630 | Fructans |