VSL#3 and Spontaneous Bacterial Peritonitis

NCT01701297 | Terminated Phase 2 DMC

• 3 other identifiers: 10GA0212010-022886-9210/H0405/81
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Research question: Do oral probiotics in patients with cirrhosis and ascites reduce intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to antibiotics or placebo? This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of "healthy" bacteria for the intestines) compared to an antibiotic or placebo in preventing infection developing in the abdominal fluid ("ascites") that collects in patients with advanced liver disease ("cirrhosis"). Patients already having had infection will be excluded from the study. Clear inclusion and exclusion criteria will be met and patients will be monitored throughout the study to examine whether they have required more hospitalisations, their rate infection in abdominal fluid or elsewhere and the level of liver function.

Conditions

Decompensated Cirrhosis; Ascites

Keywords

Cirrhosis, ascites, infection

Outcome Measures

Primary Outcomes (1)

• Liver-related mortality and liver related morbidity

  12 months

Secondary Outcomes (1)

• Incidence of SBP, variceal bleeding, any non-SBP sepsis (e.g. pneumonia, urinary tract infection), clinical episodes of encephalopathy and the incidence of C. difficile infection.

  12 months

Study Arms (3)

Co-trimoxazole

ACTIVE COMPARATOR

Co-trimoxazole 960mg daily po

Drug: cotrimoxazole

VSL#3 active

EXPERIMENTAL

VSL#3 active 2 sachets/daily

Drug: VSL#3 active

VSL#3 placebo

PLACEBO COMPARATOR

VSL#3 placebo 2 sachets/daily

Drug: VSL#3 placebo

Interventions

cotrimoxazole DRUG

Cotrimoxazole 960mg orally each day (two 480mg tablets)

Also known as: Cotrimoxazole (septrin)

Co-trimoxazole

VSL#3 active DRUG

The prescribed dose was 2 sachets (containing 900 billion bacteria) orally each day for 48 weeks

VSL#3 active

VSL#3 placebo DRUG

This was two placebo sachets identical to VSL#3 active sachet. The prescribed dose was 2 sachets orally each day for 48 weeks

VSL#3 placebo

Eligibility Criteria

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

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with required disease/severity/symptoms as outlined in 6.3.1.
• Stable dose of current regular medication (e.g. diuretics, beta-blockers, vitamin supplementation) for at least 4 weeks prior to study entry.
• Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
• Participants have clinically acceptable laboratory tests and ECG within 14 days of enrolment.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Willing to allow their General Practitioner and consultant

You may not qualify if:

• Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
• Presence of hepatocellular carcinoma
• Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
• Participant who is terminally ill
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Use of antibiotics or probiotics in the last 2 weeks
• Known hypersensitivity to trimethoprim, sulphonamides or any other ingredients in co-trimoxazole tablet.
• History of acute porphyria or serious haematological disorder.
• Participants who have participated in another research study involving an investigational product in the past 12 weeks

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• VSL Pharmaceuticals: collaborator

Study Sites (1)

NUH NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Ascites; Fibrosis; Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Martin W James, BM BS FRCP PhD

  NUH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: October 5, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)