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

Hospital General de Mexico

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome With Diarrhea

Treatments: Drug: lactobacillus LB; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04053790

DI/18/107/03/080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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177 participants in 3 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

LB 10000

Active Comparator group

Description:

Patients in this group will receive placebo 1 tablet containing 5,000 millions of lactobacillus LB, every 12 hours, during 4 weeks.

Treatment:

Drug: lactobacillus LB

LB 20000

Active Comparator group

Description:

Patients in this group will receive placebo 1 tablet containing 10,000 millions of lactobacillus LB, every 12 hours, during 4 weeks.

Treatment:

Drug: lactobacillus LB