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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053790
• Other study ID #: DI/18/107/03/080
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: January 29, 2023
• Est. primary completion date: January 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• lactobacillus LB
administration of different doses of Lactobacillus LB according to the treatment groups described previously

Other:
• placebo
a tablet of placebo every 12 hours given by mouth

Locations

Country	Name	City	State
Mexico	Hospital General de Mexico	Mexico City	Choose Any State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in the number of stools per day	weekly average number of evacuations / day, comparing before and after treatment	4 weeks
Secondary	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
Secondary	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
Secondary	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