Probiotic-enriched Artichoke in Functional Constipation (PAFC)

This study has been completed.
Sponsor:
Collaborator:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by (Responsible Party):
Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier:
NCT01212146
First received: September 29, 2010
Last updated: December 23, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Functional Constipation
Dietary Supplement: Lactobacillus paracasei IMPC 2.1 LMGP22043
Dietary Supplement: Ordinary artichokes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind, Crossover Clinical Trial to Assess the Efficacy of Lactobacillus Paracasei Enriched Artichokes in the Treatment of Functional Constipation

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:

Primary Outcome Measures:
  • Treatment preference [ Time Frame: After treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days) ] [ Designated as safety issue: No ]
    The participants will be asked about treatment preference (the period with least symptoms) at the last visit.


Secondary Outcome Measures:
  • Visual analogue score (VAS) of satisfactory relief of symptoms [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The participants will be asked about satisfactory relief of symptoms by using a visual analogue scale (VAS) with grades from 0 (no relief) to 100 (best imaginable relief of symptoms). VAS values will be categorized in 4 classes: 0-25: no or poor relief of symptoms, 26-50: moderate relief of symptoms; 51-75: good relief of symptoms; 76-100: very good relief of symptoms.

  • GSRS sum score [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The GSRS (Gastrointestinal Symptom Scoring Rate) is a validated questionnaire for GI symptoms. GSRS utilizes a seven-level Likert scale (1 to 7), depending on intensity and frequency of GI symptoms.


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.
Active Comparator: Ordinary artichokes
Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212146

Locations
Italy
National Institute for Digestive Diseases IRCCS "S. de Bellis"
Castellana Grotte, Bari, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
Study Director: Giuseppe Riezzo, MD National Institute of Digestive Diseases IRCCS "S. de Bellis"
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Russo, MD, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT01212146     History of Changes
Other Study ID Numbers: 0818G
Study First Received: September 29, 2010
Last Updated: December 23, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:
Artichokes
Constipation
Functional Foods
Prebiotics
Probiotics

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014