Trial Outcomes & Findings for 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 (NCT NCT00958308)
NCT ID: NCT00958308
Last Updated: 2012-03-13
Results Overview
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.
COMPLETED
PHASE3
255 participants
Up to 40 days
2012-03-13
Participant Flow
1120 patients screened, 255 enrolled at the Xinhua/Yuyao Hospital, Shangai Jiao Tong University, China between Oct. 2008 and March 2009.
Inclusion \& exclusion criterias were used to randomized patients.
Participant milestones
| Measure |
Placebo
Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285® & Placebo
One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285
Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
85
|
86
|
|
Overall Study
COMPLETED
|
84
|
85
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=84 Participants
Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285® & Placebo
n=85 Participants
One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285
n=86 Participants
Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
60.4 years
STANDARD_DEVIATION 5.88 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 6.32 • n=5 Participants
|
60 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
84 participants
n=5 Participants
|
85 participants
n=7 Participants
|
86 participants
n=5 Participants
|
255 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 40 daysIncidence 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.
Outcome measures
| Measure |
Placebo
n=84 Participants
Two capsules of placebo (devoid of microorganisms)per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285® & Placebo
n=85 Participants
One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285
n=86 Participants
Two capsules of probiotic (each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
|---|---|---|---|
|
To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
|
84 participants
|
85 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Up to 40 daysDuration 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 40 daysIf 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 40 daysAdverse events were reported by patients in the three study groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 40 daysEpisodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
BIO-K+ CL-1285® & Placebo
BIO-K+ CL-1285
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=84 participants at risk
Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285® & Placebo
n=85 participants at risk
One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
BIO-K+ CL-1285
n=86 participants at risk
Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
|
|---|---|---|---|
|
General disorders
Fever and hematochezia
|
2.4%
2/84
|
0.00%
0/85
|
1.2%
1/86
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60