Probiotic-enriched Artichoke in Functional Constipation

NCT01212146 | Completed

• 1 other identifier: 0818G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Keywords

Artichokes; Constipation; Functional Foods; Prebiotics; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

Probiotic-enriched Artichokes

EXPERIMENTAL

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

Ordinary artichokes

ACTIVE COMPARATOR

Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes

Dietary Supplement: Ordinary artichokes

Interventions

Lactobacillus paracasei IMPC 2.1 LMGP22043 DIETARY_SUPPLEMENT

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.

Probiotic-enriched Artichokes

Ordinary artichokes DIETARY_SUPPLEMENT

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.

Ordinary artichokes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (1)

National Institute for Digestive Diseases IRCCS "S. de Bellis"

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (4)

• Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004 Apr;99(4):750-9. doi: 10.1111/j.1572-0241.2004.04114.x.

  PMID: 15089911 BACKGROUND

• 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. doi: 10.1017/S0007114507730751. Epub 2007 Apr 20.

  PMID: 17445348 BACKGROUND

• 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. doi: 10.1128/AEM.72.4.3042-3045.2006.

  PMID: 16598015 BACKGROUND

• Riezzo G, Orlando A, D'Attoma B, Guerra V, Valerio F, Lavermicocca P, De Candia S, Russo F. Randomised clinical trial: efficacy of Lactobacillus paracasei-enriched artichokes in the treatment of patients with functional constipation--a double-blind, controlled, crossover study. Aliment Pharmacol Ther. 2012 Feb;35(4):441-50. doi: 10.1111/j.1365-2036.2011.04970.x. Epub 2012 Jan 8.

  PMID: 22225544 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Riezzo, MD

  National Institute of Digestive Diseases IRCCS "S. de Bellis"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 26, 2011

Record last verified: 2011-12

Locations

IT (1)