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

NCT04111471 | Completed

• 1 other identifier: 2019-2801
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microbial Colonization

Keywords

Microbiome; Prebiotic

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Bacterial Resistance genes in stool

  Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant

Study Arms (2)

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)

Dietary Supplement: Placebos

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)

Dietary Supplement: Prebiotics

Interventions

Prebiotics DIETARY_SUPPLEMENT

Enrolled patients will receive 10 grams of inulin daily for 21 days

Also known as: inulin

Prebiotic (Inulin) Arm

Placebos DIETARY_SUPPLEMENT

Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days

Also known as: Maltodextrin

Placebo Arm

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 2-18 years
• Allogeneic Stem Cell transplant
• Myeloablative therapy
• Inpatient at Lurie Children's Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Prebiotics; Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Fructans

Study Officials

• Mehreen M Arshad, MD

  Lurie Children's/Northwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of Pediatric Infectious Diseases

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: October 1, 2019
• Study Start: October 31, 2019
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)