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Probiotic-enriched Artichoke in Functional Constipation (PAFC)

A

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status

Completed

Conditions

Functional Constipation

Treatments

Dietary Supplement: Ordinary artichokes
Dietary Supplement: Lactobacillus paracasei IMPC 2.1 LMGP22043

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

30 participants in 2 patient groups

Probiotic-enriched Artichokes
Experimental group
Description:
Artichokes containing approximately 1.20 x 10\^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme
Treatment:
Dietary Supplement: Lactobacillus paracasei IMPC 2.1 LMGP22043
Ordinary artichokes
Active Comparator group
Description:
Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes
Treatment:
Dietary Supplement: Ordinary artichokes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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