Status:
COMPLETED
L. Reuteri DSM 17938 and L. Reuteri ATCC PTA 6475 in Moderate to Severe Irritable Bowel in Adults
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Collaborating Sponsors:
BioGaia AB
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Randomized, double blind, controlled clinical trial, to evaluate safety and efficacy of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475 as adjuvant to reduce the severity of symptoms in adults with ...
Detailed Description
Rationale: Irritable bowel syndrome (IBS) is the most commonly diagnosed functional gastrointestinal disorder observed in older children and adults. It is a frequent cause of chronic abdominal pain an...
Eligibility Criteria
Inclusion
- Age 18-65 years
- Any gender
- ROME IV diagnostic criteria for IBS
- A baseline GSRS-IBS score (Spanish/LA version) moderate to severe IBS
- Body Mass Index (BMI) 25 to 35
- Patient capable of conforming to the protocol
- Signed Informed consent
Exclusion
- Patients with relevant systemic, organic or metabolic diseases
- Patients with abnormal laboratory values that could be relevant to the outcome of study treatment
- Previous recent major abdominal surgery
- Consumption of antibiotics, Proton-Pump Inhibitors, H2-antagonists or dietary supplements containing Lactobacillus reuteri within 2 weeks prior to base-line
- Pregnancy
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04037826
Start Date
July 12 2018
End Date
December 30 2022
Last Update
June 27 2023
Active Locations (2)
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1
Instituto de Nutricion y Tecnologia de los Alimentos
Santiago, Chile
2
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico, 14080