Skip to main content
OpenTrials
Completed

NCT Number: NCT00958308

Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
  • Expected to remain hospitalized for a minimum of 5 days
  • Patients who have received less than 36 hours of antibiotic therapy
  • Negative pregnancy test at screening
  • Obtained his/her informed consent after verbal and written information
  • Patients having a telephone available (mobile, work, home)
  • Patients having a fridge at home

Exclusion criteria

  • Pregnant or breastfeeding women
  • Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
  • Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
  • Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
  • Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
  • A previous documented C. Difficile infection < 3 months prior to study initiation ;
  • Ostomized patients, parenteral nutrition users
  • Patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (AIDS))
  • Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration.
  • Patients with planned administration of antibiotics other than broad spectrum Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;
  • Patients with concomitant participation in another clinical trial;
  • Patients who are not likely to comply with study requirements

Treatment and study plan

BIO-K+ CL-1285®

Other

A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

Placebo

Other

Placebo is devoid of microorganisms.

Primary outcomes

  1. To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.

    Time frame: Up to 40 days

    Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.

Secondary outcomes

  1. Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.

    Time frame: Up to 40 days

    Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.

  2. Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.

    Time frame: Up to 40 days

    If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.

  3. Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.

    Time frame: Up to 40 days

    Adverse events were reported by patients in the three study groups.

  4. Frequencies of Other Gastrointestinal Symptoms.

    Time frame: Up to 40 days

    Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.

Sponsors and collaborators

Lead sponsor

Bio-K Plus International Inc.

Industry

Collaborators

  • Sprim Advanced Life Sciences

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2009
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.