Clinical trial: the effects of a fermented milk containing three probiotic bacteria in patients with irritable bowel syndrome - a randomized, double-blind, controlled study.
BACKGROUND
The effects of probiotic bacteria in IBS remain controversial.


OBJECTIVE
To study the effects of a probiotic product on IBS symptoms.


METHODS
We randomized 74 IBS patients to receive 8 weeks of daily treatment with 400 mL milk fermented with the yoghurt bacteria and containing Lactobacillus paracasei, ssp. paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 (Cultura; active) or acidified milk without these bacteria (control). The primary endpoint was the proportion of subjects reporting adequate relief of their IBS symptoms at least 50% of the weeks. IBS symptom severity, psychological symptoms and quality of life were assessed.


RESULTS
The proportion of responders was 38% (14/37 patients) in the active group and 27% (10/37 patients) in the control group (P = 0.3). IBS symptom severity improved significantly in both groups during the treatment period. This change was greater in the active group during the first 2 weeks, but thereafter, no significant group differences were seen.


CONCLUSIONS
We could not detect a clearly positive effect of fermented milk containing three probiotic bacteria on GI symptoms in IBS patients compared with the control treatment. However, a trend towards a more favourable effect during the first weeks was seen in the active group.
Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden. magnus.simren@medicine.gu.se
M
M
Simrén
L
L
Ohman
J
J
Olsson
U
U
Svensson
K
K
Ohlson
I
I
Posserud
H
H
Strid
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000382:microbiology*; D043183:Irritable Bowel Syndrome / Q000178:diet therapy* / Q000523:psychology; D007779:Lactobacillus acidophilus; D008297:Male; D008875:Middle Aged; D008892:Milk / Q000382:microbiology*; D010349:Patient Compliance; D019936:Probiotics / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult