DiarrhoeaNU278NCT01087892
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
A study testing Probiotic drink containing the live strain in people with Diarrhoea and Clostridium Difficile, run by University of Sussex at 26 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Diarrhoea, Clostridium Difficile
- What is being tested?
- Probiotic drink containing the live strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,126 participants
- Where
- 26 sitesUnited Kingdom
- Study dates
- Oct 2009to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United Kingdom26 sites
Ashford and St Peters Hospital
Ashford, KT 0PZ
Blackpool Vicotria Hospital
Blackpool, FY3 8NR
Royal Sussex County Hospital
Brighton, BN2 5BE
Cambridge University Hospital Trust
Cambridge, CB2 2QQ
Broomfield Hospital
Chelmsford, CM1 7HT
St.Richards Hospital
Chichester, PO19 6SE
Colchester Hospitals University
Colchester, CO4 5JL
Ealing Hospital
Ealing, UB1 3HW
Eastbourne District General Hospital
Eastbourne, BN21 2YS
Frimley Park Hospital
Frimley, SW17 7HS
Princess Royal Hospital
Haywards Heath, RH16 4EX
Hillingdon Hospital
Hillingdon, UB8 3NN
Lancashire Teaching Hospital
Lancaster, PR2 9HT
University Hosppitals of Leicester
Leicester, LE2 7LX
Lewisham Helathcare NHS Trust
Lewisham, SE13 6LH
Kings College Hospital
London, SE5 9RS
St Georges Hospital London
London, SW17 0RE
Queen Elizabeth Queen Mother Hospital
Margate, CT9 4AN
University Hospitals of Morecambe Bay
Morecambe, LA1 4RP
Norfolk and Norwich University
Norwich, NR4 7UY
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY
Worcestershire Acute Hospitals
Redditch, BN8 7UB
East Surrey Hospital
Redhill, RH1 5RH
Maidstone and Tunbridge Wells NHS Trust
Royal Tunbridge Wells, ME16 9QQ
University Hospital Southampton
Southampton, SO16 6YD
Yeovil District Hospital
Yeovil, BA21 4AT
About this study
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.
Read the 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.
- Conditions
- Diarrhoea, Clostridium Difficile
- Being tested
- Probiotic drink containing the live strain, placebo probiotic
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic drink containing the live strainDietary supplement
Probiotic drink contains no strain
placebo probioticDietary supplement
Placebo product is a sweetened flavoured, non fermented, acidified dairy drink
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement Probiotic drink | Active comparator | Double blind
Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days Receives: Dietary Supplement: Probiotic drink containing the live strain |
| Dietary supplement probiotic placebo drink | Placebo comparator | 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 Receives: Dietary Supplement: placebo probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of diarrhoea
The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period
Measured: regular intervals for 28days from entry to trial
Secondary outcomes (5)
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
Measured: regular intervals for 28 days from entry to trial
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
Measured: regular intervals for 28 days from entry to trial
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
Measured: regular intervals for 28 days from entry to trial
The quality of life in the active and placebo groups at enrollment into the study
Measured: regular intervals for 28 days from entry to trial
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
Measured: regular intervals for 28 days from entry to trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International
- Responsible party
- Sponsor
- Investigators
- Chakravarthi Rajkumar, Study chair, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087892
- Sponsor's protocol ID
- UKCRN7582
- Acronym
- NU278
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2010
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT01087892
- Acronym / sponsor ID
- NU278 / UKCRN7582
- Conditions
- Diarrhoea, Clostridium Difficile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,126 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Collaborators
- Danone Institute International
- Study start
- Oct 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement Probiotic drink | Active comparator | Dietary Supplement: Probiotic drink containing the live strainDouble blind Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days |
| Dietary supplement probiotic placebo drink | Placebo comparator | Dietary Supplement: placebo probioticDouble 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic drink containing the live strainProbiotic drink contains no strain | Dietary supplement | Dietary supplement Probiotic drink |
| placebo probioticPlacebo product is a sweetened flavoured, non fermented, acidified dairy drink | Dietary supplement | Dietary supplement probiotic placebo drink |
Primary outcome
The incidence of diarrhoea
Time frame: regular intervals for 28days from entry to trial
The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period
5 secondary outcomes
incidence and duration of Clostridium difficile toxin
Time frame: regular intervals for 28 days from entry to trial
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
Time frame: regular intervals for 28 days from entry to trial
rate of recurrence of Clostridium difficile toxin positive diarrhoea
Time frame: regular intervals for 28 days from entry to trial
The quality of life in the active and placebo groups at enrollment into the study
Time frame: regular intervals for 28 days from entry to trial
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
Time frame: regular intervals for 28 days from entry to trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chakravarthi Rajkumar study chair
University of Sussex
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic drink containing the live strain in people with Diarrhoea and Clostridium Difficile, run by University of Sussex at 26 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of diarrhoea (time frame: regular intervals for 28days from entry to trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.