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Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection (NU278)

Primary Purpose

Diarrhoea, Clostridium Difficile

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Probiotic drink containing the live strain

placebo probiotic

About this trial

This is an interventional prevention trial for Diarrhoea

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally Inclusion in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours

Exclusion Criteria:

Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness

Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis.

Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dietary supplement Probiotic drink

Dietary supplement probiotic placebo drink

Arm Description

Double blind Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days

Double blind 'placebo' is actually a control product Placebo drink contains no strain 100gs orally, twice daily for the duration of the course of antibiotics plus seven days

Outcomes

Primary Outcome Measures

The incidence of diarrhoea

The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period

Secondary Outcome Measures

incidence and duration of Clostridium difficile toxin

The incidence and duration of Clostridium difficile toxin detected by ELISA positive testing from a stool sample taken at the onset of diarrhoea in the active and placebo groups

The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period

rate of recurrence of Clostridium difficile toxin positive diarrhoea

The rate of recurrence of Clostridium difficile toxin positive diarrhoea in the active and placebo groups from hospital discharge until the end of the follow-up period

The quality of life in the active and placebo groups at enrollment into the study

The length of hospital stay from enrollment into the study until the end of the follow up period in the active and placebo groups The cost-effectiveness as evidenced by health economic calculations

Full Information

NCT ID

NCT01087892

First Posted

March 15, 2010

Last Updated

March 27, 2020

Sponsor

University of Sussex

Collaborators

Danone Institute International

1. Study Identification

Unique Protocol Identification Number

NCT01087892

Brief Title

Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Acronym

NU278

Official Title

Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sussex

Collaborators

Danone Institute International

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Antibiotics are currently required to treat patients in hospital when they have an infection, but these antibiotics can cause side effects such as diarrhoea and in some patients a serious form of gut infection with an organism called Clostridium difficile. This organism can produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill health, and in some circumstances can be fatal. Some studies have shown that yogurts' or Probiotics' (special drinks with a defined concentration of useful bacteria) taken by patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics use. The aim of the present study is to find out whether the use of one of these Probiotics in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium difficile infection, as well as cost saving. The study will also analyze the effects of probiotics on quality of life and length of hospital stay.

Detailed Description

As part of this study, we will look at both microbiological and immunological markers, in addition to analyzing the overall cost implications by analysis of health economics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhoea, Clostridium Difficile

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary supplement Probiotic drink

Arm Type

Active Comparator

Arm Description

Double blind Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days

Arm Title

Dietary supplement probiotic placebo drink

Arm Type

Placebo Comparator

Arm Description

Double blind 'placebo' is actually a control product Placebo drink contains no strain 100gs orally, twice daily for the duration of the course of antibiotics plus seven days

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic drink containing the live strain

Intervention Description

Probiotic drink contains no strain

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo probiotic

Intervention Description

Placebo product is a sweetened flavoured, non fermented, acidified dairy drink

Primary Outcome Measure Information:

Title

The incidence of diarrhoea

Description

The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period

Time Frame

regular intervals for 28days from entry to trial

Secondary Outcome Measure Information:

Title

incidence and duration of Clostridium difficile toxin

Description

The incidence and duration of Clostridium difficile toxin detected by ELISA positive testing from a stool sample taken at the onset of diarrhoea in the active and placebo groups

Time Frame