Status:
UNKNOWN
Evaluation of the Metabolome in Diverticular Disease
Lead Sponsor:
S.Eugenio Hospital
Conditions:
Simple Diverticular Disease
Eligibility:
FEMALE
18+ years
Brief Summary
To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin a...
Detailed Description
The incidence of diverticular disease of the colon has increased over the last few years. Since it presents potentially severe complications (both in terms of morbidity and mortality), the most recent...
Eligibility Criteria
Inclusion
- Female patients over 18 years of age
- Patient with a diagnosis of uncomplicated symptomatic diverticular disease diagnosed for the first time
- Patient able to comply with the procedures of the Protocol
- Ability to sign written informed consent
Exclusion
- Segmental colitis associated with diverticulosis
- Inflammatory Bowel Disease
- Active or recent peptic ulceration
- Chronic renal failure
- Known allergy to products in the study
- Use of lactulose-lactitol in the two weeks prior to enrollment and during the study
- Previous surgery of the colon
- Diverticular disease-related complications (fistulas, abscesses, stenosis)
- Use of probiotics in the 4 weeks prior to enrolment
- Renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disease, if found to be clinically significant
- Active malignancy or history of any type of malignancy.
- Recent history or suspicion of abuse of alcohol or drugs
- Women who are pregnant, nursing or of childbearing age not using appropriate contraceptive methods
- Any severe pathology that may interfere with the treatment
- Inability to provide written informed consent
- Not sufficiently reliable or presence of conditions that can result in non-compliance / patient adherence to the Protocol
- Previous participation in another study
- Lack of compliance towards the products in the study
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01831323
Start Date
December 1 2012
End Date
May 1 2015
Last Update
October 17 2014
Active Locations (1)
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1
Sant'Eugenio Hospital
Rome, RM, Italy, 00144