Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial.
BACKGROUND
Health-related quality of life (HRQoL) has been rarely evaluated as a primary endpoint in the assessment of the effect of probiotics on the irritable bowel syndrome (IBS).


OBJECTIVE
To study the effects of fermented milk containing Bifidobacterium animalis DN-173 010 and yoghurt strains on the IBS in a multicentre, double-blind, controlled trial.


METHODS
A total of 274 primary care adults with constipation-predominant IBS (Rome II) were randomized to consume for 6 weeks either the test fermented milk or a heat-treated yoghurt (control). HRQoL and digestive symptoms were assessed after 3 and 6 weeks on an intention-to-treat population of 267 subjects.


RESULTS
The HRQoL discomfort score, the primary endpoint, improved (P < 0.001) in both groups at weeks 3 and 6. The responder rate for the HRQoL discomfort score was higher (65.2 vs. 47.7%, P < 0.005), as was the decrease in bloating score [0.56 +/- (s.d.)1.01 vs. 0.31 +/- 0.87, P = 0.03], at week 3 in the test vs. the control group. In those subjects with <3 stools/week, stool frequency increased (P < 0.001) over 6 weeks in the test vs. control group.


CONCLUSIONS
This study suggests a beneficial effect of a probiotic food on discomfort HRQoL score and bloating in constipation-predominant IBS, and on stool frequency in subjects with <3 stools/week.
Guyonnet
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Danone Research, Route Départementale 128, 91767 Palaiseau, France. denis.guyonnet@danone.com
Chassany
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O
Ducrotte
P
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Picard
C
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Mouret
M
M
Mercier
C-H
CH
Matuchansky
C
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D039941:Bifidobacteriales Infections / Q000382:microbiology* / Q000628:therapy; D001644:Bifidobacterium; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000382:microbiology* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D019936:Probiotics / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome; D015014:Yogurt / Q000382:microbiology*