Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis) (CREED)

May 19, 2023 updated by: University of Aberdeen

Drinking large amount of alcohol can cause damage to the liver. If the liver is severely injured by alcohol it can become very inflamed and this condition is called alcoholic hepatitis. Alcoholic hepatitis can be life threatening. There is no cure for alcoholic hepatitis. It is known that stop drinking and have good nutrition can help the liver to recover.

Infections are very common for people who suffer from alcoholic hepatitis. Sometimes these infection can be very severe. It is not always possible to find out where the infection is coming from. But the bacteria living in the bowel may move to other organs causing these infections and an illness like alcoholic hepatitis can cause "bad bacteria" to take over from "good bacteria" in the gut.

This study wants to understand the changes in the bacteria in the bowel of people who have an acute inflammation of the liver cause by alcohol (alcoholic hepatitis).

The investigators will take stool samples from patients admitted in the hospital with alcoholic hepatitis. The investigators will run tests on the stools that can find out which bacteria live in the bowel. Its is expected to find these bacteria to be different from the ones living in the bowel of healthy people. The investigators are interested to see if these bacteria change once the patients are given good nutrition using a small tube from the nose to the stomach. This type of nutrition is used routinely to help improve the liver in severe alcoholic hepatitis. The investigators will take some more stool sample from these patients after the nutrition through the tube has started to check how the bacteria change with nutrition.

Better tools to check the bacteria in the bowel are now available so this can help the investigators to understand better if changing bacteria in the bowel can help recovery in alcoholic hepatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects admitted to hospital with a diagnosis of alcoholic hepatitis and who are planned to receive nasogastric feeding for at least 7 days will be eligible for the study.

A stool sample will be collected prior to commence enteral nutrition via nasogastric tube and analysed. Subsequently further stool samples will be collected and analysed at day 3 and day 7 after commencing nasogastric feeding.

DNA will be extracted from each of the samples, and bacterial 16S rRNA genes will be PCR amplified and sent for sequencing at the CGEBM using an Illumina MiSeq machine. This will generate at least 2 million paired end reads (2 x 300 bp), which will be assembled and analysed using the Mothur software platform.The investigators will also analyse the short chain fatty acids profiles within the stool samples using gas chromatography. Shannon Diversity Index will be used to assess the bacterial diversity and Pielou's index will be used to assess species evenness at each time point. Comparison between time points will be performed. Microbiota composition at the different time points will be assessed using Mothur software to detect if there are systematic changes to specific members of the gut microbiota during enteral feeding. Prevalence by different molecular methodologies will be assessed and the results from study patients will be compared with their baseline samples by Fisher's exact test.

Missing data will be handled using a missing indicator.

Subjects will be approached by the team in charge of the clinical care and option to enter the study will be offered. Information leaflet will be provided to the subject 24h before consenting and possibility to discuss with trial team.

Data will be collected by authorised members of trial team in a fit for purpose ad hoc password protected excel data base as eCRF. Source data will be electronic patient file or paper case notes. Source data of microbiome analysis will be computer report. Accuracy of data entry will be checked by a separate delegated member of the team. External monitoring occurs at a regular basis for clinical trial arrange by sponsor.

Patient confidentiality will be maintained at all time. No identifiable data will be collected. eCRF will be password protected and stored in encrypted hospital computer protected by password. consent or other paper documentation will be kept separate in locked cabinets within the premises of the hospital.

Adverse Events reporting will be performed by a competent and delegated member of staff, according to our sponsor standard operating procedure and recorded.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

- adults admitted to hospital. Diagnosis of alcoholic hepatitis. Expected to receive nasogastric feeding for at least 3 days.

Description

Inclusion Criteria:

  • Adults patients: age 16 and above
  • Diagnosis of alcoholic hepatitis confirmed by treating hepatologists and defined as:
  • Bilirubin >80 umol/l
  • Documented history of continuing alcohol harmful use
  • ALT< 500 umol/L
  • Clinical decision to start NG feeding and prospect to continue NG feeding >3 days

Exclusion Criteria:

  • Age <16
  • Hepatocellular carcinoma
  • Pregnancy and breastfeeding
  • Inability to provide informed consent
  • Any reasons in the opinion of the investigator which can compromise participation in the trial or affect patient health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subjects
subjects with alcoholic hepatitis receiving NG feeding
Dietary supplement: NG feeding
NG feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alteration of bacterial microbiome diversity and evenness following enteral feeding in alcoholic hepatitis
Time Frame: 7 days
To understand how the gut microbiome changes in patients with AH following enteral feeding.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019GA002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

we will plan to share all patient IPD, protocol including analysis plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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