Role Of Lactobacillus Reuteri DSM 17938 In The Non-Complicated Diverticular Disease

NCT ID: NCT01168154

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-12-31

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.

Detailed Description

The gastrointestinal apparatus hosts a bacterial population that quantifies to around 1011 microorganisms per gram of content with more than 400 different species. Its principal functions are: metabolic, trophic, and protective. The Lactobacillus reuteri (Reuterin®) is considered one of the few native species in the human intestinal tract. It is able to modulate the immune response CD4+ T-Helper to an ileum level. Lactobacillus reuteri isolated for the first time in 1980 is a heterofermantative species. Its probiotic activity is attributed to the ability to exercise an inhibitive effect on the pathogenic micro-organisms with a combination of mechanisms including the production of lactic acid, hydrogen peroxide, antimicrobic substances and bactericide. Moreover, Lactobacillus reuteri is in a position to produce various short chain-like fat acids such as the acetic acid from the fermentation of carbohydrates. At last, it is in a position to produce a powerful antimicrob substance known as Reuterina that is capable of inhibiting the growth of many bacterial species including Escherichia, Salmonella, Shigella, Proteus, Pseudomonas, Clostridium and Sfafilococcus as well as fungi and protozoa, many of which are pathogens for man.

Among pathologies in which it is hypothesized that probiotics could have a possible therapeutic role, there is the diverticulosis disease. Approximately 20% of patients with colonic diverticula have intestinal disturbances and a reduction of the quality of life. Moreover approximately 20% of the patients with diverticulosis in the colon have at least 1 acute diverticulitis attack, characterized by pain, fever, abdominal defence, increment of the VES and neutrophil leucocytosis. Usually the acute diverticulitis episode can be controlled by medical therapy, but repeated episodes in time often lead to greater complications in the perforation, from the abdominal abscesses, from the fistulas and from the stenosis. The prevention of acute diverticulitis episodes is therefore very important so as to prevent greater complications of such pathology.

Until now, the scientific evidences have suggested the use of fibre and non-absorbable antibiotics (such as rifaximine) for the treatment of a non-complicated diverticular disease and for the prophylaxis of the feared complications. The extended use of antibiotics exposes to the risk of selecting resistant strains and there are no long-term studies on the outcome of the patients suffering from diverticulosis in continuous therapy with rifaximine and fibres. The therapy with Lactobacillus reuteri could be effective in the control of symptoms of the diverticular disease through its trophic action on coloncytes (thanks to the SCFA production), both through the modulation of the activity of the immune system and on the intestinal permeability. Moreover the antibacterial activity of Lactobacillus reuteri against the pathogenic bacteria could be useful in the prevention and the treatment of acute diverticulitis episodes. Finally, thanks to its trophic role on the intestinal epithelium, Lactobacillus reuteri could help the mucosal cure of acute diverticulitis episodes.

Conditions

Diverticulosis; Diverticulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lactobacillus Reuterii

Group Type: ACTIVE_COMPARATOR

Lactobacillus Reuterii

Intervention Type: DIETARY_SUPPLEMENT

Lactobacillus Reuterii 10000000000 CFU per day

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo

Interventions

Lactobacillus Reuterii

Lactobacillus Reuterii 10000000000 CFU per day

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Adult patients affected by symptomatic diverticulosis
• Informed consent obtained and signed.
• Expected compliance

Exclusion Criteria

• Patients supplemented with other probiotics
• Patients treated with antibiotics
• Patients affected by hearth failure, renal failure, neoplasia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Careggi Hospital

OTHER

Sponsor Role: collaborator

Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Casa Sollievo della Sofferenza Hospital

Locations

Careggi Hospital

Florence, , Italy

Site Status: NOT_YET_RECRUITING

Casa Sollievo della Sofferenza Hospital - IRCCS

San Giovanni Rotondo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabrizio Bossa, MD

Role: CONTACT

f.bossa@operapadrepio.it

00390882410235

Angelo Andriulli, MD

Role: CONTACT

a.andriulli@operapadrepio.it

00390882410263

Facility Contacts

Vito Annese, MD

Role: primary

annesev@aou-careggi.toscana.it

00390557946035

Fabrizio Bossa, MD

Role: primary

f.bossa@operapadrepio.it

00390882410235

Angelo Andriulli, MD

Role: backup

a.andriulli@operapadrepio.it

00390882410263

Other Identifiers

ReDiCo

Identifier Type: -

Identifier Source: org_study_id