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NCT04671186 · ClinicalTrials.gov registry record · NA

Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan

A NA study, sponsored by Northwell Health.

Completed
Registry status
NA
Development phase
47
Enrollment target

NCT04671186: Completed NA study, sponsored by Northwell Health.

NCT04671186 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04671186, a NA study, has completed, sponsored by Northwell Health.

COMPLETED
Registry status
NA
Development phase
47 participants
Enrollment target

Study Summary

The goal of this study is to evaluate the role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis and fibrosis with a Fibroscan machine. This will be done by performing a fibroscan during each visit and comparing patients' ALT at various intervals. This is an important study as current pediatric guidelines only recommend lifestyle modifications for the treatment of NAFLD and the use of ALT and sonogram to assess improvement as standard of care. Investigators hypothesized that treatment with a probiotic will demonstrate an improvement in NAFLD as assessed by a fibroscan of liver which is good for the monitoring of steatosis and fibrosis. Additionally, analysis of fecal microbiome results may offer insight into targeted therapy in the future.

Primary Outcome

The primary endpoint/outcome assesses the effect of probiotic treatment in liver steatosis by assessing with fibroscan using CAP score.

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT Culturelle (Lactobacillus rhamnosus strain GG)

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2020-09-07
Est. Completion 2023-03-01
Phase NA
Northwell Health

370 total trials

What the finished NCT04671186 record still lists

NCT04671186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04671186 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04671186 about?

NCT04671186 is a clinical study titled "Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan". The goal of this study is to evaluate the role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis and fibrosis with a Fibroscan machine. This will be done by performing a fibroscan during each visit and comparing patients' ALT at various intervals. This is an important stu...

What is the current status of trial NCT04671186?

This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2020-09-07. Estimated completion is 2023-03-01.

What interventions are being tested in trial NCT04671186?

The interventions under investigation include: Placebo (OTHER), Culturelle (Lactobacillus rhamnosus strain GG) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04671186?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04671186's enrollment target sits among peer trials

47 1400th of 2000 higher than 599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04671186, the US trial registry maintained by the National Library of Medicine. NCT04671186 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.