Microbiome alterations in the setting of intestinal failure associated liver disease

K
Katie Huff

Primary Investigator

Enrolling By Invitation
18 months or below
All
Phase N/A
24 participants needed
1 Location

Brief description of study

What is the purpose of this study?
Neonates who require prolonged IV nutrition (TPN) are at risk for such complications as intestinal failure associated liver disease (IFALD). In addition, it is also known that TPN and lack of nutrition through the GI tract influences the intestinal microbiome or bacteria present in the gut. We want to define if there is a difference in the intestinal microbiome between patients on TPN with and without IFALD.
 
The study is being conducted by Dr. Katie Huff, MD from Indiana University School of Medicine, Division of Neonatology. It is funded by the Indiana University School of Medicine Department of Pediatrics.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will all be neonates admitted to the Riley NICU, either Simon Family Tower or Maternity Tower who have been identified as being on IV nutrition for 4 weeks.  Parents will be contacted by research team either in person or via phone about study participation.

Detailed description of study

What will happen during the study?
  • In this study we want to take stool samples from babies on IV nutrition for at least 4 weeks.
  • We plan to compare the stool samples of those patients who do not have liver irritation (Group A) to those with liver irritation (Group B).
  • Each baby’s stool samples will be stored for up to 10 years and each individual specimen may be used up to 5 times.
  • Stool samples will only be collected once during this study. Medical information will be recorded during the baby’s NICU stay only and no further information will be collected after they are discharged from the hospital.
     

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Intestinal failure associated liver disease, IFALD, Riley
  • Age: 18 months or below
  • Gender: All

Eligibility Criteria
Group A
Inclusion Criteria: 
3.    Infant admitted to the Riley Simon Family Tower or Maternity Tower NICU who have been on TPN at least 4 weeks (28 days).

Exclusion Criteria

1.    Patients with liver disease not due to parenteral nutrition.
a.    Concern for congenital infection including TORCH infections
b.    Patients with sepsis within the last 2 weeks with positive blood, urine, or CSF cultures.
c.    Patients with high suspicion for biliary atresia.
d.    Concern for inborn error of metabolism

2.    Patient with cholestasis or other signs of liver disease
a.    Direct bilirubin >2mg/dL
b.    AST or ALT >2 times upper limit of normal

Group B
Inclusion Criteria
1.    Infant admitted to the Riley Simon Family Tower or Maternity Tower NICU who have been on TPN at least 4 weeks (28 days).
2.    Direct bilirubin >2 mg/dL

Exclusion Criteria
1.    Patients with liver disease not due to parenteral nutrition.
a.    Concern for congenital infection including TORCH infections
b.    Patients with sepsis within the last 2 weeks with positive blood, urine, or CSF cultures.
c.    Patients with high suspicion for biliary atresia.
d.    Concern for inborn error of metabolism

Updated on 08 May 2025. Study ID: PNEO-IIR-IM-PTPN, 20561
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only