Probiotic-enriched Artichoke in Functional Constipation (PAFC)
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|ClinicalTrials.gov Identifier: NCT01212146|
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : December 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Functional Constipation||Dietary Supplement: Lactobacillus paracasei IMPC 2.1 LMGP22043 Dietary Supplement: Ordinary artichokes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||September 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2011|
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.
- 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) ]The participants will be asked about treatment preference (the period with least symptoms) at the last visit.
- 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) ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212146
|National Institute for Digestive Diseases IRCCS "S. de Bellis"|
|Castellana Grotte, Bari, Italy, 70013|
|Study Director:||Giuseppe Riezzo, MD||National Institute of Digestive Diseases IRCCS "S. de Bellis"|