Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii
      (Lactobacillus LB) has proven to be effective and safe for the treatment of acute diarrhea in
      children. Also, a clinical trial in adult patients with chronic diarrhea, showed a reduction
      in the number of daily stools. However, the evidence is not enough regarding the efficacy and
      safety of Lactobacillus LB for treatment of patients with irritable bowel syndrome with
      predominance of diarrhea (IBS-D).

      Justification for this study: Lactobacillus LB could be a promising treatment for patients
      with IBS-D; nevertheless, the scientific evidence in this context is limited and it is not
      recent. Therefore, is necessary to explore the efficacy and safety of Lactobacillus LB in
      patients with IBS-D according to Rome IV criteria.

      Hypothesis: Lactobacillus LB is useful to decrease the frequency and improve the stools
      consistency of patients diagnosed with IBS-D by Rome IV criteria.

      Primary Outcome: To compare the treatment with Lactobacillus LB at two different doses: a)
      20,000 million / day, vs. b) 10,000 million / day; and to determine if one of them is better
      than c) placebo, to decrease the frequency (weekly average of the number of stools/day) in
      patients diagnosed with IBS-D by Rome IV criteria.

      Design of the study: Clinical trial, randomized, double-blind, placebo-controlled.

      Keywords: irritable bowel syndrome with diarrhea, Lactobacillus LB, treatment, efficacy,
      safety.
    

Detailed description: 
      Background: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii
      (Lactobacillus LB) has proven to be effective and safe for the treatment of acute diarrhea in
      children. Also, a clinical trial in adult patients with chronic diarrhea showed a reduction
      in the number of daily stools. However, the evidence is not enough regarding the efficacy and
      safety of Lactobacillus LB for the treatment of patients with irritable bowel syndrome with a
      predominance of diarrhea (IBS-D).

      Justification for this study: Lactobacillus LB could be a promising treatment for patients
      with IBS-D; nevertheless, the scientific evidence in this context is limited and it is not
      recent. Therefore, is necessary to explore the efficacy and safety of Lactobacillus LB in
      patients with IBS-D according to Rome IV criteria.

      Hypothesis: Lactobacillus LB is useful to decrease the frequency and improve the stools
      consistency of patients diagnosed with IBS-D by Rome IV criteria.

      Primary Outcome: To compare the treatment with Lactobacillus LB at two different doses: a)
      20,000 million / day, vs. b) 10,000 million / day; and to determine if one of them is better
      than c) placebo, to decrease the frequency (weekly average of the number of stools/day) in
      patients diagnosed with IBS-D by Rome IV criteria.

      Design of the study: Clinical trial, randomized, double-blind, placebo-controlled.

      Keywords: irritable bowel syndrome with diarrhea, Lactobacillus LB, treatment, efficacy,
      safety.
    

Intervention name(s): lactobacillus LB; placebo
Intervention type(s): Drug; Other
Intervention description(s): administration of different doses of Lactobacillus LB according to the treatment groups described previously; a tablet of placebo every 12 hours given by mouth
Other intervention name(s): Lactobacillus fermentum + lactobacillus delbrueckii, lyophilized powder; Lacteol; inactive principle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: irritable bowel syndrome with diarrhea; Lactobacillus LB; treatment; safety; efficacy