A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial.
BACKGROUND
Some probiotics have shown efficacy for patients with irritable bowel syndrome (IBS). Lactobacillus (L.) plantarum MF1298 was found to have the best in vitro probiotic properties of 22 strains of lactobacilli. The aim of this study was to investigate the symptomatic effect of L. plantarum MF1298 in subjects with IBS. Primary outcome was treatment preference and secondary outcomes were number of weeks with satisfactory relief of symptoms and IBS sum score.


METHODS
The design was a randomised double blind placebo-controlled crossover trial. 16 subjects with IBS underwent two three-week periods of daily intake of one capsule of 10(10) CFU L. plantarum MF 1298 or placebo separated by a four-week washout period.


RESULTS
Thirteen participants (81%; 95% CI 57% to 93%; P = 0.012) preferred placebo to L. plantarum MF1298 treatment. The mean (SD) number of weeks with satisfactory relief of symptoms in the periods with L. plantarum MF1298 and placebo were 0.50 (0.89) and 1.44 (1.26), respectively (P = 0.006). IBS sum score was 6.44 (1.81) in the period with L. plantarum MF1298 treatment compared with 5.35 (1.77) in the period with placebo (P = 0.010). With a clinically significant difference in the IBS sum score of 2 in disfavour of active treatment, the number needed to harm was 3.7, 95% CI 2.3 to 10.9.


CONCLUSIONS
This trial shows for the first time an unfavourable effect on symptoms in subjects with IBS after intake of a potential probiotic.
Ligaarden
Solveig C
SC
Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway. solveig.ligaarden@ntnu.no
Axelsson
Lars
L
Naterstad
Kristine
K
Lydersen
Stian
S
Farup
Per G
PG
D015746:Abdominal Pain / Q000209:etiology; D000328:Adult; D000368:Aged; D003248:Constipation / Q000209:etiology; D003967:Diarrhea / Q000209:etiology; D005243:Feces / Q000382:microbiology; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000178:diet therapy*; D048191:Lactiplantibacillus plantarum / Q000302:isolation & purification / Q000472:pathogenicity; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects*; D013045:Species Specificity