Probiotic-enriched Artichoke in Functional Constipation

Study Overview
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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.

Official Title
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A Randomized Double-blind, Crossover Clinical Trial to Assess the Efficacy of Lactobacillus Paracasei Enriched Artichokes in the Treatment of Functional Constipation

Conditions
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Functional Constipation

Intervention / Treatment
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* Dietary Supplement: Lactobacillus paracasei IMPC 2.1 LMGP22043
* Dietary Supplement: Ordinary artichokes


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic-enriched Artichokes<br>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<br>* 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.<br>|
| Active Comparator: Ordinary artichokes<br>Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes | Dietary Supplement: Ordinary artichokes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment preference | The participants will be asked about treatment preference (the period with least symptoms) at the last visit. | After treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue score (VAS) of satisfactory relief of symptoms | 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. | 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) | 
| GSRS sum score | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artichokes, Constipation, Functional Foods, Prebiotics, Probiotics