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

Sponsor

Hospital General de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04053790

Collaborator

(none)

177

Enrollment

Location

Arms

46.5

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome With Diarrhea	Drug: lactobacillus LB Other: placebo	Phase 4

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).

Hypothesis: Lactobacillus LB is useful to decrease the frequency and improve the stools consistency of 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

177 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jan 15, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo group Patients in this group will receive placebo 1 tablet every 12 hours, during 4 weeks.	Other: placebo a tablet of placebo every 12 hours given by mouth Other Names: inactive principle
Active Comparator: LB 10000 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 administration of different doses of Lactobacillus LB according to the treatment groups described previously Other Names: treatment group
Active Comparator: LB 20000 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 administration of different doses of Lactobacillus LB according to the treatment groups described previously Other Names: treatment group

Arm

Intervention/Treatment

Placebo Comparator: placebo group

Patients in this group will receive placebo 1 tablet every 12 hours, during 4 weeks.

Other: placebo

a tablet of placebo every 12 hours given by mouth

Other Names:

inactive principle

Active Comparator: LB 10000

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

administration of different doses of Lactobacillus LB according to the treatment groups described previously

Other Names:

treatment group

Active Comparator: LB 20000

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

administration of different doses of Lactobacillus LB according to the treatment groups described previously

Other Names:

treatment group

Outcome Measures

Primary Outcome Measures

decrease in the number of stools per day [4 weeks]
weekly average number of evacuations / day, comparing before and after treatment

Secondary Outcome Measures

improvement in the consistency of the stools according to Bristol scale. [4 weeks]
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.
improvement in bloating measured by a Likert scale (0-4) [4 weeks]
Likert scale: 0=without bloating, 1=mild bloating, 2=moderate bloating, 3=severe bloating
improvement in abdominal pain measured by a Likert scale (0-4) [4 weeks]
Likert scale: 0=without pain, 1=mild pain, 2=moderate pain, 3=severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.