Trial record 12 of 24 for:    Open Studies | "Diverticulitis"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Casa Sollievo della Sofferenza IRCCS.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Careggi Hospital
Information provided by:
Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:
NCT01168154
First received: July 22, 2010
Last updated: June 27, 2011
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Diverticulosis
Diverticulitis
Dietary Supplement: Lactobacillus Reuterii
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Lactobacillus Reuterii in Patients With Symptomatic Non-complicated Diverticular Disease

Resource links provided by NLM:


Further study details as provided by Casa Sollievo della Sofferenza IRCCS:

Primary Outcome Measures:
  • Reduction of 50% of the score of activity of the diverticular disease [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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).


Secondary Outcome Measures:
  • Reduction of 20% of acute diverticulitis episodes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To value the efficancy in reduction of acute diverticulitis, defined as episodes of abdominal pain associated with fever and/or abdominal resistance, increment of ESR and neutrophil leucocitosis and that demand a treatment of systemic antibiotics


Estimated Enrollment: 160
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactobacillus Reuterii Dietary Supplement: Lactobacillus Reuterii
Lactobacillus Reuterii 10000000000 CFU per day
Placebo Comparator: Placebo Dietary Supplement: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168154

Contacts
Contact: Fabrizio Bossa, MD 00390882410235 f.bossa@operapadrepio.it
Contact: Angelo Andriulli, MD 00390882410263 a.andriulli@operapadrepio.it

Locations
Italy
Careggi Hospital Not yet recruiting
Florence, Italy, 50141
Contact: Vito Annese, MD    00390557946035    annesev@aou-careggi.toscana.it   
Principal Investigator: Vito Annese, MD         
Casa Sollievo della Sofferenza Hospital - IRCCS Recruiting
San Giovanni Rotondo, Italy, 71013
Contact: Fabrizio Bossa, MD    00390882410235    f.bossa@operapadrepio.it   
Contact: Angelo Andriulli, MD    00390882410263    a.andriulli@operapadrepio.it   
Sub-Investigator: Fabrizio Bossa, MD         
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Careggi Hospital
  More Information

No publications provided

Responsible Party: Fabrizio Bossa, Casa Sollievo della Sofferenza Hospital
ClinicalTrials.gov Identifier: NCT01168154     History of Changes
Other Study ID Numbers: ReDiCo
Study First Received: July 22, 2010
Last Updated: June 27, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Casa Sollievo della Sofferenza IRCCS:
Diverticula
Diverticular disease
Diverticulitis
Probiotics

Additional relevant MeSH terms:
Diverticulitis
Diverticulum
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intraabdominal Infections
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014