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Clinical Trials/EUCTR2011-006269-17-GB
EUCTR2011-006269-17-GB
Active, not recruiting
Phase 1

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

Cardiff University, Research & Development Commercial Department0 sites400 target enrollmentSeptember 10, 2012
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ConditionsAntibiotic Associated DiarrhoeaMedDRA version: 14.1 Level: LLT Classification code 10055956 Term: Antibiotic-associated diarrhoea System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Body processes [G] - Microbiological Phenomena [G06]
DrugsVSL#3

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Antibiotic Associated Diarrhoea
Sponsor
Cardiff University, Research & Development Commercial Department
Enrollment
400
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 10, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Cardiff University, Research & Development Commercial Department

Eligibility 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
  • •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.

Outcomes

Primary Outcomes

Not specified

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