Role Of Lactobacillus Reuteri DSM 17938 In The Non-Complicated Diverticular Disease
ReDiCo
Phase 3 Study of Lactobacillus Reuterii in Patients With Symptomatic Non-complicated Diverticular Disease
1 other identifier
interventional
160
1 country
2
Brief Summary
The aim of this study is to evaluate the effectiveness and the tolerability of the Lactobacillus reuteri in the control of the diverticular disease symptoms and in the prevention of acute diverticulitis episodes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2009
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 28, 2011
October 1, 2008
3.8 years
July 22, 2010
June 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of 50% of the score of activity of the diverticular disease
A validated questionnaire was used to investigate on intestinal symptoms. The following symptoms/signs will be investigated: * Abdominal pain * Abdominal bloating * Urgency * Diarrhoea * Abdominal Tension Each factor previously listed will be graded according to the following scale of gravity: * 0= no symptom * 1= light disturbance * 2= moderate disturbance * 3= serious disturbance The score of activities can range between 0 (asymptomatic patient) to 15 (serious disturbances with important impacts on the quality of life).
1 year
Secondary Outcomes (1)
Reduction of 20% of acute diverticulitis episodes
1 year
Study Arms (2)
Lactobacillus Reuterii
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Lactobacillus Reuterii 10000000000 CFU per day
Eligibility Criteria
You may qualify if:
- Adult patients affected by symptomatic diverticulosis
- Informed consent obtained and signed.
- Expected compliance
You may not qualify if:
- Patients supplemented with other probiotics
- Patients treated with antibiotics
- Patients affected by hearth failure, renal failure, neoplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Casa Sollievo della Sofferenza IRCCSlead
- Careggi Hospitalcollaborator
Study Sites (2)
Careggi Hospital
Florence, 50141, Italy
Casa Sollievo della Sofferenza Hospital - IRCCS
San Giovanni Rotondo, 71013, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
February 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
June 28, 2011
Record last verified: 2008-10