Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea.
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|ClinicalTrials.gov Identifier: NCT03647995|
Recruitment Status : Terminated (Were not able to enroll enough participants due to shortage of study staff)
First Posted : August 27, 2018
Last Update Posted : October 26, 2020
The objective of this study is to determine the efficacy of probiotics containing 25Bn (billion) CFU (colony-forming unit) of Lactobacillus rhamnosus, Sacchromyces boulardii and Bifidobacterium breve in the prevention of antibiotic induced diarrhea and Clostridium difficile diarrhea.
The chosen population consists of 190 hospitalized patients taking antibiotics. Preselected and randomized patients will take probiotics once daily until 1 week after the course of antibiotic is over or a placebo with 0 CFU.
The primary outcome is to detect the occurrence of an antibiotic-associated diarrhea. The secondary outcome is to assess the presence of Clostridium difficile toxins in stool culture.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea, Clostridium Difficile||Dietary Supplement: Probiolife by Green Made (Pharma M) Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
The randomization will be taken care of by the hospital pharmacy which will not be in contact with the patient.
The intern/resident who will recruit a patient in the study will not be in direct contact with the pharmacy.
The order will be sent to the pharmacy which, following a randomization sheet, will then send a neutral box containing a probiotic or a placebo product.
Only once the trial comes to an end, the investigator will receive from the pharmacy the randomization sheet and will then know which patient was given a probiotic and which was given a placebo regimen.
|Official Title:||Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea; A Randomized Double Blind Placebo Controlled Trial.|
|Actual Study Start Date :||September 1, 2018|
|Actual Primary Completion Date :||February 2, 2019|
|Actual Study Completion Date :||February 2, 2019|
Active Comparator: Probiotic-receiving group
The probiotic-receiving group will receive once daily probiotics containing 25Bn CFU of which: 5Bn CFU Lactobacillus rhamnosus GG, 5Bn CFU Sacchromyces boulardii, 5Bn CFU Bifidobacterium breve, 4.5Bn CFU Bifidobacterium lactis, 2.5 Bn CFU Lactobacillus acidophilus, 2.5Bn CFU Lactobacillus plantarum and 500Mn CFU Lactobacillus reuteri.
Dietary Supplement: Probiolife by Green Made (Pharma M)
A box containing 30 capsules of a dietary supplement containing 25 Bn CFU (detailed in previous sections)
Placebo Comparator: Placebo
The placebo group will receive once daily, identical capsules containing 0 Bn CFU.
A box containing 30 capsules containing an inactive substance with 0 Bn CFU.
- Occurrence of an antibiotic-associated diarrhea. [ Time Frame: From the first day of inclusion in the trial up to a month after the antibiotic regimen is stopped. ]Diarrhea is defined as more than two liquid stools for a period greater than 3 days and which is considered by the patient as an increase in stool quantity compared to regular basis, evaluated in a patient on antibiotics.
- Presence of Clostridium difficile toxins in stool culture. [ Time Frame: Upon eventual onset of diarrhea, from the first day of inclusion in the trial and up to a month after the antibiotic regimen is stopped; in hospitalized patients only. ]Presence of Clostridium difficile toxins A and/or toxins B in the stool culture, evaluated in a patient on antibiotics presenting with diarrhea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647995
|Saint Joseph University of Beirut|