Evaluation of the Metabolome in Diverticular Disease

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Female

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 and by mesalazine, and assessing the evolution over time after each specific treatment

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S.Eugenio Hospital
• Treatments: Anti-Bacterial Agents; Anti-Inflammatory Agents; Calcium polycarbophil; Mesalamine; Psyllium; Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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