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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Casa Sollievo della Sofferenza IRCCS.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168154
First Posted: July 23, 2010
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Careggi Hospital
Information provided by:
Casa Sollievo della Sofferenza IRCCS
July 22, 2010
July 23, 2010
June 28, 2011
February 2009
December 2012   (Final data collection date for primary outcome measure)
Reduction of 50% of the score of activity of the diverticular disease [ Time Frame: 1 year ]

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).
Same as current
Complete list of historical versions of study NCT01168154 on ClinicalTrials.gov Archive Site
Reduction of 20% of acute diverticulitis episodes [ Time Frame: 1 year ]
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
Same as current
Not Provided
Not Provided
 
Role Of Lactobacillus Reuteri DSM 17938 In The Non-Complicated Diverticular Disease
Phase 3 Study of Lactobacillus Reuterii in Patients With Symptomatic Non-complicated Diverticular Disease
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diverticulosis
  • Diverticulitis
  • Dietary Supplement: Lactobacillus Reuterii
    Lactobacillus Reuterii 10000000000 CFU per day
  • Dietary Supplement: placebo
    placebo
  • Active Comparator: Lactobacillus Reuterii
    Intervention: Dietary Supplement: Lactobacillus Reuterii
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
December 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01168154
ReDiCo
Yes
Not Provided
Not Provided
Fabrizio Bossa, Casa Sollievo della Sofferenza Hospital
Casa Sollievo della Sofferenza IRCCS
Careggi Hospital
Not Provided
Casa Sollievo della Sofferenza IRCCS
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP