VSL#3 ® May Reduce Abdominal Pain and Bloating in Ulcerative Colitis Remission with IBS-like Symptoms: An Exploratory Randomized, Double-Blind Placebo-Controlled Trial.
Level 2 - randomized trial
Randomized, double-blind, placebo-controlled clinical trial
PubMed 42514326 · doi:10.3390/nu18142257
What was done
In an exploratory, randomized, double-blind, placebo-controlled trial, 55 adults with ulcerative colitis (UC) in stable remission (≥6 months) experiencing IBS-like symptoms (Rome IV C1 or C4) were randomized to receive either VSL#3 (450 billion CFU twice daily) or placebo for 8 weeks. The primary endpoint was symptom relief at week 8 measured by the 5-point Subject's Global Assessment of Relief scale. Secondary endpoints included Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) scores, bowel habits, fecal calprotectin, IBS-QoL, and IBDQ.
What was found
The primary endpoint did not differ significantly between the VSL#3 and placebo groups at week 8. Between-group differences in total IBS-SSS scores were also not statistically significant at week 8, though reductions in symptom severity and abdominal pain were numerically greater with VSL#3. In exploratory subgroup analyses of patients with higher baseline abdominal pain and bloating scores, within-group improvements were statistically significant with VSL#3 but not placebo. The abstract provides no exact numerical values, effect sizes, or p-values.
Why it matters
IBS-like symptoms frequently affect patients with quiescent UC, but this trial found no statistically significant benefit of VSL#3 over placebo on its primary endpoint, highlighting the need for larger confirmatory trials before recommending routine use.
Limits
The sample size was small (n = 55), and the trial failed to meet its primary efficacy endpoint. Positive findings were limited to secondary, numerical trends and exploratory within-group subgroup analyses rather than robust between-group differences. No quantitative data or p-values were reported in the abstract.
Cited by
- supports VSL#3 probiotic sachets contain 450 billion CFU, which is approximately 10 times higher than what most probiotic supplements contain.