Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04053790 |
Other study ID # |
DI/18/107/03/080 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
January 15, 2019 |
Est. completion date |
January 29, 2023 |
Study information
Verified date |
March 2023 |
Source |
Hospital General de Mexico |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.