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Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea.

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ClinicalTrials.gov Identifier: NCT03647995
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Pharma M
Information provided by (Responsible Party):
Yara El Helou, Saint-Joseph University

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea; A Randomized Double Blind Placebo Controlled Trial.
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
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.
Other: Placebo
A box containing 30 capsules containing an inactive substance with 0 Bn CFU.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients hospitalized on antibiotics (single or multiple; oral or IV) assuming that they are able to eat/drink so that they can take the pills.
  • Regimen started within 48 hours of first course of antibiotics.
  • Able to sign a consent form.

Exclusion Criteria:

diarrhea on admission; bowel pathology that could result in diarrhea (eg. IBD), bowel surgeries and pouches; immunocompromised state (including febrile aplasia, immunosuppressive therapy, ICU patients, HIV-positive patients and renal transplant patients); prosthetic heart valves or history of endocarditis and rheumatic heart disease; use of metronidazole, vancomycin or fidaxomycin prior to stool culture for Clostridium difficile toxins.


Information from the National Library of Medicine

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


Contacts
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Contact: Yara El Helou, BSc +96171694624 yaranhelou@gmail.com
Contact: Gebrael Saliba, MD +9613207897 gebraelsaliba@gmail.com

Sponsors and Collaborators
Yara El Helou
Pharma M

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Responsible Party: Yara El Helou, Medical Student, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT03647995     History of Changes
Other Study ID Numbers: ProbioSJU
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yara El Helou, Saint-Joseph University:
Probiotics
Diarrhea
Clostridium difficile
Antibiotics
Antibiotic-associated diarrhea
Clostridium difficile-associated diarrhea
Microbial flora

Additional relevant MeSH terms:
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Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents