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Probiotic-enriched Artichoke in Functional Constipation

NCT ID: NCT01212146

Last Updated: 2011-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Functional Constipation

Keywords

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Artichokes Constipation Functional Foods Prebiotics Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic-enriched Artichokes

Artichokes containing approximately 1.20 x 10\^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme

Group Type EXPERIMENTAL

Lactobacillus paracasei IMPC 2.1 LMGP22043

Intervention Type DIETARY_SUPPLEMENT

participants will complement their usual lifestyles and dietary intakes with probiotic artichokes, enriched with the probiotic strain Lactobacillus paracasei IMPC2.1 (LMGP22043). The product contains approximately 1.20 x 10\^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme, which resulted in a daily dose of about 2 x 10\^10 CFU.

Ordinary artichokes

Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes

Group Type ACTIVE_COMPARATOR

Ordinary artichokes

Intervention Type DIETARY_SUPPLEMENT

Probiotic artichokes will be tested against ordinary artichokes (probiotic free) of identical shape, texture, and appearance produced by the same manufacturer. Artichokes will be put in similar packages and there will be no way to distinguish between the two products.

Interventions

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Lactobacillus paracasei IMPC 2.1 LMGP22043

participants will complement their usual lifestyles and dietary intakes with probiotic artichokes, enriched with the probiotic strain Lactobacillus paracasei IMPC2.1 (LMGP22043). The product contains approximately 1.20 x 10\^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme, which resulted in a daily dose of about 2 x 10\^10 CFU.

Intervention Type DIETARY_SUPPLEMENT

Ordinary artichokes

Probiotic artichokes will be tested against ordinary artichokes (probiotic free) of identical shape, texture, and appearance produced by the same manufacturer. Artichokes will be put in similar packages and there will be no way to distinguish between the two products.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

OTHER_GOV

Sponsor Role collaborator

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role lead

Responsible Party

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Francesco Russo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Riezzo, MD

Role: STUDY_DIRECTOR

National Institute of Digestive Diseases IRCCS "S. de Bellis"

Locations

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National Institute for Digestive Diseases IRCCS "S. de Bellis"

Castellana Grotte, Bari, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 15089911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17445348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16598015 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22225544 (View on PubMed)

Other Identifiers

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0818G

Identifier Type: -

Identifier Source: org_study_id