Clinical trial NCT01244945: Lactobacillus Reuteri DSM 17938 in Functional Constipation
Official title: Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Constipation
Keywords: Functional Constipation
Functional Foods
Probiotics
Lactobacillus reuteri
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the last century in western countries. In the USA and Northern Europe, constipation is twofold the prevalence found in the East and Southern Europe. In Italy, constipation affects up to 15-17% of the whole adult population. Of them, more than half (about 10%) treats this disorder by assuming laxatives, while the remaining does not even assume drugs. A close relationship between intestinal environment and bacterial flora has been found. As a matter of fact changes in the intestinal physiology can modify the composition of bacterial flora as well as modifications in the intestinal microbiota can modify the physiology of the gut. The probiotic effects on the GI motility can be due to substances released by bacteria and/or products of their fermentation. Also, probiotic may indirectly act by the release of neuroendocrine factors and/or substances released by the immune system. Clinically, it has already been demonstrated that probiotics exert a positive effect on symptoms and intestinal habit in constipated IBS patients. In this framework, the idea to perform a long lasting intervention study in patients with functional constipation treated with probiotics sounds convincing. The present study is a randomized, double blind, placebo controlled, monocentric study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria. Clinical, physiological, hematological and immunologic variables will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Fulfilment of the Rome Criteria III for functional constipation
* Availability of at least one GI imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)
* Commitment to availability for the whole study period

Exclusion Criteria:

* Major abdominal surgery
* Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness
* Alarming symptoms (rectal bleeding, weight loss, etc)
* Family history of peptic ulcer, colorectal cancer, or IBD
* Abnormal laboratory data or thyroid function.

Primary outcomes:
measure: Improvement in gastrointestinal symptoms after 3 months of probiotic administration
timeFrame: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
Secondary outcomes:
measure: Changes in metabolic parameters after 3 months of probiotic administration
timeFrame: Before the start of the study (time 0) and after 90 days of treatment (Time 90)
measure: Changes in physiological parameters after 3 months of probiotic administration
timeFrame: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute for Digestive Diseases IRCCS "S. de Bellis"
state: Bari
Study officials:
affiliation: Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"
name: Giuseppe Riezzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. The effects of probiotics on feeding tolerance, bowel habits, and gastrointestinal motility in preterm newborns. J Pediatr. 2008 Jun;152(6):801-6. doi: 10.1016/j.jpeds.2007.11.005. Epub 2007 Dec 26.
citation: Russo F, Clemente C, Linsalata M, Chiloiro M, Orlando A, Marconi E, Chimienti G, Riezzo G. Effects of a diet with inulin-enriched pasta on gut peptides and gastric emptying rates in healthy young volunteers. Eur J Nutr. 2011 Jun;50(4):271-7. doi: 10.1007/s00394-010-0135-6. Epub 2010 Oct 12.
citation: Riezzo G, Clemente C, Leo S, Russo F. The role of electrogastrography and gastrointestinal hormones in chemotherapy-related dyspeptic symptoms. J Gastroenterol. 2005 Dec;40(12):1107-15. doi: 10.1007/s00535-005-1708-7.
citation: Riezzo G, Chiloiro M, Russo F. Functional foods: salient features and clinical applications. Curr Drug Targets Immune Endocr Metabol Disord. 2005 Sep;5(3):331-7. doi: 10.2174/1568008054863790.
citation: Valerio F, Russo F, de Candia S, Riezzo G, Orlando A, Lonigro SL, Lavermicocca P. Effects of probiotic Lactobacillus paracasei-enriched artichokes on constipated patients: a pilot study. J Clin Gastroenterol. 2010 Sep;44 Suppl 1:S49-53. doi: 10.1097/MCG.0b013e3181d2dca4.