Probiotic-enriched Artichoke in Functional Constipation

Functional Constipation Clinical Trial

— PAFC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212146
• Other study ID #: 0818G
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: December 23, 2011
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	National Institute for Digestive Diseases IRCCS "S. de Bellis"	Castellana Grotte	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004 Apr;99(4):750-9. Review. — View Citation

Kleessen B, Schwarz S, Boehm A, Fuhrmann H, Richter A, Henle T, Krueger M. Jerusalem artichoke and chicory inulin in bakery products affect faecal microbiota of healthy volunteers. Br J Nutr. 2007 Sep;98(3):540-9. Epub 2007 Apr 20. — View Citation

Valerio F, De Bellis P, Lonigro SL, Morelli L, Visconti A, Lavermicocca P. In vitro and in vivo survival and transit tolerance of potentially probiotic strains carried by artichokes in the gastrointestinal tract. Appl Environ Microbiol. 2006 Apr;72(4):3042-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No