Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03359499
• Date of registration: 25/11/2017
• Prospective Registration: No
• Primary sponsor: Hospital Britanico
• Public title: Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients
• Scientific title: Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study
• Date of first enrolment: August 12, 2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03359499
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Argentina

Contacts

• Name: Juan S Lasa, MD
• Affiliation: Hospital Britanico

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients with non-constipated irritable bowel syndrome according to Rome IV
criteria

Exclusion Criteria:

- Allergy to Bacillus clausii spores

- Prior treatment with antibiotics or probiotics (4 weeks)

- Not willing to fulfill symptom diary

- Pregnancy or breastfeeding

- Clinical suspicion of organic disease



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Drug: Bacillus clausii

Drug: Trimebutine

Primary Outcome(s)

Symptomatic response [Time Frame: After two weeks of treatment]

Secondary Outcome(s)

Symptomatic relapse [Time Frame: Four weeks after treatment completion]

Secondary ID(s)

HB744

Source(s) of Monetary Support

Please refer to primary and secondary sponsors