Probiotic-enriched Artichoke in Functional Constipation

Not Applicable

Completed

• Conditions: Functional Constipation
• Interventions: Dietary Supplement: Lactobacillus paracasei IMPC 2.1 LMGP22043; Dietary Supplement: Ordinary artichokes

• Registration Number: NCT01212146
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-23
• Last Update Posted: 2011-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotic-enriched Artichokes	Lactobacillus paracasei IMPC 2.1 LMGP22043	Artichokes containing approximately 1.20 x 10\^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme
Ordinary artichokes	Ordinary artichokes	Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes

Primary Outcome Measures

Name	Time	Method
Treatment preference	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.

Secondary Outcome Measures

Name	Time	Method
Visual analogue score (VAS) of satisfactory relief of symptoms	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	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.

Trial Locations

Locations (1)

National Institute for Digestive Diseases IRCCS "S. de Bellis"; 🇮🇹 Castellana Grotte, Bari, Italy