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Probiotic-enriched Artichoke in Functional Constipation

NCT01212146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-12-26

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

DIETARY_SUPPLEMENT

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.

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.

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Giuseppe Riezzo, MD · National Institute of Digestive Diseases IRCCS "S. de Bellis"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-01-31
Completion
2011-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212146 on ClinicalTrials.gov