Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 98 for:    grams | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111471
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Newman, Ann & Robert H Lurie Children's Hospital of Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Microbial Colonization Drug: Prebiotics Drug: Placebos Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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
Primary Purpose: Basic Science
Official Title: The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

Arm Intervention/treatment
Placebo Comparator: Placebo Arm
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)
Drug: Placebos
Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days
Other Name: Maltodextrin

Experimental: Prebiotic (Inulin) Arm
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)
Drug: Prebiotics
Enrolled patients will receive 10 grams of inulin daily for 21 days
Other Name: inulin




Primary Outcome Measures :
  1. Change in alpha and beta bacterial diversity measures in stool [ Time Frame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant ]
    Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing hematopoietic stem cell transplant

  2. Change in Short Chain Fatty Acid (SCFA) levels in stool [ Time Frame: Change in baseline SCFA levels in stool at 100 days after transplant ]
    Compare the effect of oral inulin vs. placebo on SCFA levels in the stool of children undergoing hematopoietic stem cell transplant


Secondary Outcome Measures :
  1. Bacterial Resistance genes in stool [ Time Frame: Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant ]
    Determine the impact of inulin intake vs. placebo on the prevalence of genes associated with antibiotic resistance of children undergoing hematopoietic stem cell transplant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111471


Contacts
Layout table for location contacts
Contact: Alexander M Newman, MD 3122274080 anewman@luriechildrens.org
Contact: Mehreen Arshad, MD 3122274080 MArshad@luriechildrens.org

Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Alexander M Newman, MD Lurie Children's Hospital

Layout table for additonal information
Responsible Party: Alexander Newman, Fellow of Pediatric Infectious Diseases, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT04111471     History of Changes
Other Study ID Numbers: 2019-2801
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Newman, Ann & Robert H Lurie Children's Hospital of Chicago:
Microbiome
Prebiotic
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection