Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effectiveness and Safety of Lactobacillus Fermentum and Lactobacillus Delbrueckii (Lactobacillus LB) in the Treatment of Patients With Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Drug: lactobacillus LB
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients meeting Rome IV criteria for IBS-D, without specific medical treatment for the last 4 weeks prior to inclusion in this study. Exclusion Criteria: Presence of any chronic organic disease, consumption of any medication, patients with alterations in blood cell count, erythrocyte sedimentation rate, thyroid function tests, liver function tests, blood chemistry, anti-endomysial or anti-transglutaminase antibodies, positive test for presence of blood in stools, fecal calprotectin > 50mcg/g. Also, those who do not sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>Patients in this group will receive placebo 1 tablet every 12 hours, during 4 weeks. | Other: placebo<br>* a tablet of placebo every 12 hours given by mouth<br>* Other names: inactive principle;|
| Active Comparator: LB 10000<br>Patients in this group will receive placebo 1 tablet containing 5,000 millions of lactobacillus LB, every 12 hours, during 4 weeks. | Drug: lactobacillus LB<br>* administration of different doses of Lactobacillus LB according to the treatment groups described previously<br>* Other names: Lacteol;|
| Active Comparator: LB 20000<br>Patients in this group will receive placebo 1 tablet containing 10,000 millions of lactobacillus LB, every 12 hours, during 4 weeks. | Drug: lactobacillus LB<br>* administration of different doses of Lactobacillus LB according to the treatment groups described previously<br>* Other names: Lacteol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in the number of stools per day | weekly average number of evacuations / day, comparing before and after treatment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in the consistency of the stools according to Bristol scale. | Bristol scale: type 1= separate hard lumps, type 2= sausage shaped but lumpy, type 3= like a sausage but with cracks on ots surface, type 4= like a sausage or sanake, smooth and soft, type 5= soft blobs with clear cut-edges, type 6= fluffy pieces with ragged edges, a mushy stool, type 7 = watery, no solid pieces. | 4 weeks | 
| improvement in bloating measured by a Likert scale (0-4) | Likert scale: 0=without bloating, 1=mild bloating, 2=moderate bloating, 3=severe bloating | 4 weeks | 
| improvement in abdominal pain measured by a Likert scale (0-4) | Likert scale: 0=without pain, 1=mild pain, 2=moderate pain, 3=severe pain | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus LB, irritable bowel syndrome with diarrhea, treatment, safety, efficacy