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

NCT04544020 | Completed

• 1 other identifier: 2019GA002
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcoholic Hepatitis

Keywords

gut microbiome; NG feeding

Outcome Measures

Primary Outcomes (1)

• alteration of bacterial microbiome diversity and evenness following enteral feeding in alcoholic hepatitis

  To understand how the gut microbiome changes in patients with AH following enteral feeding.

  7 days

Study Arms (1)

subjects

subjects with alcoholic hepatitis receiving NG feeding

Dietary Supplement: NG feeding

Interventions

NG feeding DIETARY_SUPPLEMENT

NG feeding

subjects

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Related Publications (3)

• Moreno C, Deltenre P, Senterre C, Louvet A, Gustot T, Bastens B, Hittelet A, Piquet MA, Laleman W, Orlent H, Lasser L, Serste T, Starkel P, De Koninck X, Negrin Dastis S, Delwaide J, Colle I, de Galocsy C, Francque S, Langlet P, Putzeys V, Reynaert H, Degre D, Trepo E. Intensive Enteral Nutrition Is Ineffective for Patients With Severe Alcoholic Hepatitis Treated With Corticosteroids. Gastroenterology. 2016 Apr;150(4):903-10.e8. doi: 10.1053/j.gastro.2015.12.038. Epub 2016 Jan 5.

  PMID: 26764182 BACKGROUND

• Dubinkina VB, Tyakht AV, Odintsova VY, Yarygin KS, Kovarsky BA, Pavlenko AV, Ischenko DS, Popenko AS, Alexeev DG, Taraskina AY, Nasyrova RF, Krupitsky EM, Shalikiani NV, Bakulin IG, Shcherbakov PL, Skorodumova LO, Larin AK, Kostryukova ES, Abdulkhakov RA, Abdulkhakov SR, Malanin SY, Ismagilova RK, Grigoryeva TV, Ilina EN, Govorun VM. Links of gut microbiota composition with alcohol dependence syndrome and alcoholic liver disease. Microbiome. 2017 Oct 17;5(1):141. doi: 10.1186/s40168-017-0359-2.

  PMID: 29041989 BACKGROUND

• Puri P, Thursz M. Intensive Enteral Nutrition in Alcoholic Hepatitis: More Food for Thought. Gastroenterology. 2016 Apr;150(4):803-5. doi: 10.1053/j.gastro.2016.02.061. Epub 2016 Feb 26. No abstract available.

  PMID: 26924095 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

stools

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2019
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

GB (1)