THE PROBIOTICS FOR ANTIBIOTIC ASSOCIATED DIARRHOEA (PAAD) STUDY Stage II : A double blind randomised placebo controlled trial to determine the effect of probiotics on antibiotic associated diarrhoea in care home residents.

A double blind placebo controlled randomised clinical trial to study the effect of Probiotics for the prevetion or amelioration of Antibiotic Associated Diarrhoea in residents of care homes in South Wales and England - Probiotics for Antibiotic Associated Diarrhoea, (PAAD), a randomised controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006269-17-GB

Enrollment

400

Registered

2012-09-10

Start date

2012-11-16

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Associated Diarrhoea MedDRA version: 14.1 Level: LLT Classification code 10055956 Term: Antibiotic-associated diarrhoea System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: VSL#3 Product Name: VSL#3® Product Code: N/A Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: VSL#3®

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA •Resident in a care home for 24 hours or more, with a minimum planned residential care of 1 month. •Able to provide informed consent or have a personal legal representative who can provide consent for inclusion. •If the SU takes a regular probiotic but chooses to discontinue the probiotic Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA •Severely immuno-compromised, e.g. known severe neutropenia •Has artificial heart valve in situ. •Medical history of acute pancreatitis. •Requires naso-jejunal feeding /nasogastric feeding due to difficulty of administering probiotic. •Currently has a colostomy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of probiotics vs placebo, taken in conjunction with antibiotics, on the incidence of (AAD) in care home service users; Secondary Objective: •To compare the effectiveness of probiotics vs. placebo, taken in conjunction with antibiotics, on the duration and severity of AAD in care home SUs. •To compare the effectiveness of the probiotics vs. placebo in reducing the incidence of C. difficile–associated diarrhoea (CDAD) in care home SUs. •To evaluate the impact of probiotics on Quality of Life (QoL) in care home SUs. •To evaluate the cost effectiveness of probiotics for AAD in care home SUs. ;Primary end point(s): The primary outcome is the occurrence of at least one episode of AAD during the eight weeks following randomisation. AAD is defined as three or more loose stools (defined as a 5 – 7 on the British Stool Chart) in a 24 hour period following a period of normal stool consistency. ;Timepoint(s) of evaluation of this end point: Between randomisation and during eight weeks following randomisation	—

Measure

Time frame

Main Objective: To compare the effect of probiotics vs placebo, taken in conjunction with antibiotics, on the incidence of (AAD) in care home service users; Secondary Objective: •To compare the effectiveness of probiotics vs. placebo, taken in conjunction with antibiotics, on the duration and severity of AAD in care home SUs. •To compare the effectiveness of the probiotics vs. placebo in reducing the incidence of C. difficile–associated diarrhoea (CDAD) in care home SUs. •To evaluate the impact of probiotics on Quality of Life (QoL) in care home SUs. •To evaluate the cost effectiveness of probiotics for AAD in care home SUs. ;Primary end point(s): The primary outcome is the occurrence of at least one episode of AAD during the eight weeks following randomisation. AAD is defined as three or more loose stools (defined as a 5 – 7 on the British Stool Chart) in a 24 hour period following a period of normal stool consistency. ;Timepoint(s) of evaluation of this end point: Between randomisation and during eight weeks following randomisation

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Between randomisation and during eight weeks folowing randomisation; Secondary end point(s): • Proportion of stool samples positive for Clostridium difficile toxin A or B from SUs who develop AAD during the eight week follow-up period. • Duration, frequency and recurrence of AAD during the eight-week follow-up period. • QoL, measured using EQ-5D at the point of consent, at the time of randomisation and each week during the eight-week follow-up period. • Recovery from illness that triggered antibiotic treatment. • Healthcare Resource UseHealth care utilisation costs, including GP and practice nurse consultations, other medication, procedures, investigations, hospital appointments, A&E attendances and any hospital inpatient admissions, measured at the end of the eight-week follow-up period. • Unplanned hospitalisations, including all-cause and AAD related, during the eight-week follow-up period. • Adverse Events: e.g. vomiting, abdominal pain, excessive flatulence, bloating, skin rashes, during the eight-week follow-up period. • Adherence to the antibiotic, probiotic/placebo treatment course. • All causes of mortality in the 8 week follow up period.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Between randomisation and during eight weeks folowing randomisation; Secondary end point(s): • Proportion of stool samples positive for Clostridium difficile toxin A or B from SUs who develop AAD during the eight week follow-up period. • Duration, frequency and recurrence of AAD during the eight-week follow-up period. • QoL, measured using EQ-5D at the point of consent, at the time of randomisation and each week during the eight-week follow-up period. • Recovery from illness that triggered antibiotic treatment. • Healthcare Resource UseHealth care utilisation costs, including GP and practice nurse consultations, other medication, procedures, investigations, hospital appointments, A&E attendances and any hospital inpatient admissions, measured at the end of the eight-week follow-up period. • Unplanned hospitalisations, including all-cause and AAD related, during the eight-week follow-up period. • Adverse Events: e.g. vomiting, abdominal pain, excessive flatulence, bloating, skin rashes, during the eight-week follow-up period. • Adherence to the antibiotic, probiotic/placebo treatment course. • All causes of mortality in the 8 week follow up period.

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Countries

United Kingdom

Contacts

Public ContactJulia Townson

South East Wales Trials Unit (SEWTU), Cardiff University

townson@cf.ac.uk02920687606

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026