Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea
Condition: Antibiotic Side Effect; Probiotics; Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      This randomized, placebo-controlled, double-blind clinical trial aims to evaluate the
      efficacy and safety of probiotics as food supplements in preventing antibiotic-associated
      diarrhea. The study will involve 82 patients who will be randomly assigned to one of two
      groups: an experimental group receiving a probiotic containing Lactobacillus acidophilus
      LA85, and a placebo group. The primary outcomes measured include the number of days until the
      onset of diarrhea, the duration of diarrhea (if it occurs), gastrointestinal quality of life
      evaluation using the GIQLI questionnaire, and overall patient satisfaction.
    

Detailed description: 
      This randomized, placebo-controlled, double-blind clinical trial aims to assess the
      effectiveness and safety of probiotics as food supplements in preventing
      antibiotic-associated diarrhea. The study will enroll 82 patients who will be randomly
      assigned to either the experimental group or the placebo group. Participants in the
      experimental group will receive a probiotic supplement containing Lactobacillus acidophilus
      LA85, while those in the placebo group will receive a non-active substitute.

      The outcomes include the following measurements:

        1. Number of days until the onset of diarrhea.

        2. Duration of diarrhea, if it occurs.

        3. Evaluation of gastrointestinal quality of life using the GIQLI questionnaire.

        4. Overall patient satisfaction with the intervention. Throughout the trial, a double-blind
           approach will be maintained, ensuring that both the participants and the investigators
           are unaware of the treatment assignments. This helps minimize bias and ensures the
           reliability of the results. To assess the efficacy and safety of probiotics, data will
           be collected and analyzed using appropriate statistical methods. The number of days
           until the onset of diarrhea will be compared between the two groups, as well as the
           duration of diarrhea if it occurs. Gastrointestinal quality of life will be evaluated
           using the GIQLI questionnaire, which measures various aspects related to
           gastrointestinal well-being. Additionally, overall patient satisfaction with the
           intervention will be assessed. By conducting this comprehensive clinical trial, we aim
           to provide valuable insights into the potential benefits and safety of probiotics as
           food supplements in preventing antibiotic-associated diarrhea. The results obtained will
           contribute to evidence-based recommendations for healthcare professionals and may have
           implications for improving patient outcomes and quality of life.
    

Intervention name(s): Probiotic Lactobacillus acidophilus LA85
Intervention type(s): Other
Intervention description(s): Through a randomized double-blind placebo-controlled method, the patients were randomly divided into placebo group and probiotic intervention group, and took probiotics once a day for 14 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: diarrhea; probiotics; Antibiotic Side Effect