Evaluation of the Metabolome in Diverticular Disease

NCT01831323 | Unknown

• 1 other identifier: TUR-SUDD 2012
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Simple Diverticular Disease

Outcome Measures

Primary Outcomes (2)

• identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD)

  As no studies have ever been conducted or published on this aspect, the main outcome of the study is to analyze and identify the metabolome of patients with SUDD before starting any therapy and after a 2 week therapy of a probiotic, fibers or antibiotics. The metabolomic analysis will allow a precise evaluation of the systemic and organ-specific processes based on low molecular weight components thus providing a profile of the metabolic system of these patients.

  12 months

• verify changes in the intestinal microbiota following treatment in the different study groups.

  12 months

Secondary Outcomes (4)

• evaluate the symptomatology and metabolome

  12 months

• evaluate the different metabolomes and microbiota according to the treatment used

  12 months

• Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease

  12 months

• evaluate if difference in the symptomatology in the different groups are correlated with changes in the intestinal microbiota

  12 months

Study Arms (4)

mesalazine

10 female patients with first diagnosis of SUDD will take mesalazine 1,6g per day for 14 days (1 tablet 800mg twice daily)

Drug: Mesalazine

VSL#3

10 female patients with first diagnosis of SUDD will take VSL#3 2 sachets a day for 14 days (1 sachet twice a day, for a total of 900 billion bacteria per day)

Dietary Supplement: VSL#3

Rifaximin

10 female patients with first diagnosis of SUDD will take 800mg/day of rifaximin (2 tablets of 200mg twice a day)

Drug: Rifaximin

fiber

10 female patients with first diagnosis of SUDD will take fibers for 14 days (psyllium 10grams per day)

Dietary Supplement: Psyllium

Interventions

VSL#3 DIETARY_SUPPLEMENT

VSL#3

Also known as: Probiotic food supplement

VSL#3

Rifaximin DRUG

Rifaximin

Also known as: Unabsorbable antibiotic

Rifaximin

Mesalazine DRUG

Mesalazine

Also known as: anti-inflammatory drug

mesalazine

Psyllium DIETARY_SUPPLEMENT

psyllium

Also known as: Fibers

fiber

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with first diagnosis of uncomplicated symptomatic diverticular disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• S.Eugenio Hospital: lead

Study Sites (1)

Sant'Eugenio Hospital

Rome, RM, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and stools

MeSH Terms

Interventions

Rifaximin; Mesalamine; Anti-Inflammatory Agents; Psyllium

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Gianmarco Giorgetti

  Sant'Eugenio Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianmarco Giorgetti, MD

CONTACT

gianmarcogiorgetti@gmail.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dott. in Medicina Interna, Chirurgia oncologica, immunologia e allergologia

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: April 15, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

IT (1)