Clinical trial NCT01212146: Probiotic-enriched Artichoke in Functional Constipation
Official title: A Randomized Double-blind, Crossover Clinical Trial to Assess the Efficacy of Lactobacillus Paracasei Enriched Artichokes in the Treatment of Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: Artichokes
Constipation
Functional Foods
Prebiotics
Probiotics
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2010-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present randomized double-blind controlled crossover study is to compare the effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients suffering from functional constipation.

Detailed description: Functional constipation is a common problem in westernized societies and is characterized by different gastrointestinal symptoms.Different therapeutic strategies have been proposed, but a new therapeutic approach for constipation could be based on the modulation of intestinal microflora by administering prebiotics and/or probiotics. Currently, probiotic products are mainly incorporated in fermented milk-based products or concentrated probiotic preparations. To enlarge the range of choice and to exploit the nutritional qualities of plant matrices, an innovative line of probiotic vegetable products such as artichokes has been developed. The use of these vegetables containing live probiotic strains can take advantage of some their peculiar features for growth and improved bacterial survival. Artichokes can, therefore, work as valid "active" vehicles for the transport and release of adequate amounts of bacterial populations.

Eligibility criteria: Inclusion Criteria:

* fulfilment of the Rome Criteria III for 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
* the presence of any concomitant diseases such as organic GI diseases including 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: Treatment preference
timeFrame: After treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days)
Secondary outcomes:
measure: Visual analogue score (VAS) of satisfactory relief of symptoms
timeFrame: At the end of the run-in period (7 days), after treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days)
measure: GSRS sum score
timeFrame: At the end of the run-in period (7 days), after treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days)
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute for Digestive Diseases IRCCS "S. de Bellis"
state: Bari
Study officials:
affiliation: National Institute of Digestive Diseases IRCCS "S. de Bellis"
name: Giuseppe Riezzo, MD
role: STUDY_DIRECTOR
References:
citation: Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004 Apr;99(4):750-9. doi: 10.1111/j.1572-0241.2004.04114.x.
citation: Kleessen B, Schwarz S, Boehm A, Fuhrmann H, Richter A, Henle T, Krueger M. Jerusalem artichoke and chicory inulin in bakery products affect faecal microbiota of healthy volunteers. Br J Nutr. 2007 Sep;98(3):540-9. doi: 10.1017/S0007114507730751. Epub 2007 Apr 20.
citation: Valerio F, De Bellis P, Lonigro SL, Morelli L, Visconti A, Lavermicocca P. In vitro and in vivo survival and transit tolerance of potentially probiotic strains carried by artichokes in the gastrointestinal tract. Appl Environ Microbiol. 2006 Apr;72(4):3042-5. doi: 10.1128/AEM.72.4.3042-3045.2006.
citation: Riezzo G, Orlando A, D'Attoma B, Guerra V, Valerio F, Lavermicocca P, De Candia S, Russo F. Randomised clinical trial: efficacy of Lactobacillus paracasei-enriched artichokes in the treatment of patients with functional constipation--a double-blind, controlled, crossover study. Aliment Pharmacol Ther. 2012 Feb;35(4):441-50. doi: 10.1111/j.1365-2036.2011.04970.x. Epub 2012 Jan 8.