Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)
NCT ID: NCT04053790
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
177 participants
INTERVENTIONAL
2019-01-15
2023-01-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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placebo group
Patients in this group will receive placebo 1 tablet every 12 hours, during 4 weeks.
placebo
a tablet of placebo every 12 hours given by mouth
LB 10000
Patients in this group will receive placebo 1 tablet containing 5,000 millions of lactobacillus LB, every 12 hours, during 4 weeks.
lactobacillus LB
administration of different doses of Lactobacillus LB according to the treatment groups described previously
LB 20000
Patients in this group will receive placebo 1 tablet containing 10,000 millions of lactobacillus LB, every 12 hours, during 4 weeks.
lactobacillus LB
administration of different doses of Lactobacillus LB according to the treatment groups described previously
Interventions
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lactobacillus LB
administration of different doses of Lactobacillus LB according to the treatment groups described previously
placebo
a tablet of placebo every 12 hours given by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Hospital General de Mexico
OTHER_GOV
Responsible Party
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MARIA DE FATIMA HIGUERA DE LA TIJERA
Head of Gastroenterology and Hepatology Department
Principal Investigators
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Fatima Higuera de la Tijera, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Mexico
Locations
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Hospital General de Mexico
Mexico City, Choose Any State/Province, Mexico
Countries
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Other Identifiers
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DI/18/107/03/080
Identifier Type: -
Identifier Source: org_study_id
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