Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
irritable bowel syndrome with diarrhea, Lactobacillus LB, treatment, safety, efficacy
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.
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). 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.
Interventions
DRUGlactobacillus LB
administration of different doses of Lactobacillus LB according to the treatment groups described previously
OTHERplacebo
a tablet of placebo every 12 hours given by mouth
Sponsors
Hospital General de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| decrease in the number of stools per day | 4 weeks | weekly average number of evacuations / day, comparing before and after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed