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

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ClinicalTrials.gov Identifier: NCT04053790
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico

Brief Summary:

Background: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii (Lactobacillus LB) has proven to be effective and safe for 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 15, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

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

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




Primary Outcome Measures :
  1. decrease in the number of stools per day [ Time Frame: 4 weeks ]
    weekly average number of evacuations / day, comparing before and after treatment


Secondary Outcome Measures :
  1. improvement in the consistency of the stools according to Bristol scale. [ Time Frame: 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.

  2. improvement in bloating measured by a Likert scale (0-4) [ Time Frame: 4 weeks ]
    Likert scale: 0=without bloating, 1=mild bloating, 2=moderate bloating, 3=severe bloating

  3. improvement in abdominal pain measured by a Likert scale (0-4) [ Time Frame: 4 weeks ]
    Likert scale: 0=without pain, 1=mild pain, 2=moderate pain, 3=severe pain



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053790


Locations
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Mexico
Hospital General de Mexico Recruiting
Mexico City, Mexico, 06726
Contact: FATIMA HIGUERA-DE LA TIJERA, MD. MSc    +52(55)27892000 ext +7,0047    fatimahiguera@hotmail.com   
Sub-Investigator: Alfredo Servín Caamaño, MD         
Sub-Investigator: Miguel Motola-Kuba, MD         
Sub-Investigator: Cynthya Díaz-Valencia, MD         
Sub-Investigator: Diana Brizuela-Alcántara, MD. MSc         
Sub-Investigator: Félix García-Gorrosquieta, MD         
Sub-Investigator: Max Schmulson-Wasserman, MD, PhD         
Sponsors and Collaborators
Hospital General de Mexico

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Responsible Party: MARIA DE FATIMA HIGUERA DE LA TIJERA, Head of Gastroenterology and Hepatology Department, Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT04053790     History of Changes
Other Study ID Numbers: DI/18/107/03/080
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico:
irritable bowel syndrome with diarrhea
Lactobacillus LB
treatment
safety
efficacy

Additional relevant MeSH terms:
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Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases