NCT04053790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

February 20, 2019

Last Update Submit

March 2, 2023

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

irritable bowel syndrome with diarrheaLactobacillus LBtreatmentsafetyefficacy

Outcome Measures

Primary Outcomes (1)

  • decrease in the number of stools per day

    weekly average number of evacuations / day, comparing before and after treatment

    4 weeks

Secondary Outcomes (3)

  • improvement in the consistency of the stools according to Bristol scale.

    4 weeks

  • improvement in bloating measured by a Likert scale (0-4)

    4 weeks

  • improvement in abdominal pain measured by a Likert scale (0-4)

    4 weeks

Study Arms (3)

placebo group

PLACEBO COMPARATOR

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

Other: placebo

LB 10000

ACTIVE COMPARATOR

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

LB 20000

ACTIVE COMPARATOR

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

Interventions

lactobacillus LBDRUG

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

Also known as: Lactobacillus fermentum + lactobacillus delbrueckii, lyophilized powder, Lacteol
LB 10000LB 20000
placeboOTHER

a tablet of placebo every 12 hours given by mouth

Also known as: inactive principle
placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Mexico

Mexico City, Choose Any State/Province, 06726, Mexico

Location

MeSH Terms

Interventions

Lacteol

Study Officials

  • Fatima Higuera de la Tijera, MD, PhD

    Hospital General de Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gastroenterology and Hepatology Department

Study Record Dates

First Submitted

February 20, 2019

First Posted

August 13, 2019

Study Start

January 15, 2019

Primary Completion

January 29, 2023

Study Completion

January 29, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

ME(1)