Gastroenterology · Medical Literature
VSL#3® May Reduce Abdominal Pain and Bloating in Ulcerative Colitis Remission with IBS-like Symptoms: An Exploratory Randomized, Double-Blind Placebo-Controlled Trial.
Abstract
Background: Irritable bowel syndrome (IBS)-like symptoms are common in patients with ulcerative colitis (UC) in sustained clinical and endoscopic remission and are associated with impaired quality of life. Evidence for targeted treatments in this setting remains limited. Objective: To evaluate the efficacy of the multistrain probiotic VSL#3® in patients with UC in stable remission and IBS-like symptoms. Methods: In this randomized, double-blind, explorative, placebo-controlled trial, adults with UC in stable remission for ≥6 months and Rome IV C1 or C4 symptoms received VSL#3® 450 billion colony-forming units or placebo twice daily for 8 weeks. The primary endpoint was symptom relief at week 8 assessed by the 5-point Subject's Global Assessment of Relief scale. Secondary endpoints included Irritable Bowel Syndrome Symptom Severity Scale scores (IBS-SSS), bowel habits, biochemical remission assessed through fecal calprotectin, IBS-QoL, and IBDQ. Results: Fifty-five patients were randomized. The primary endpoint did not differ significantly between groups. Between-group differences in IBS-SSS total score were not statistically significant at week 8; however, numerically greater and directionally consistent reductions in symptom severity and abdominal pain were observed with VSL#3® across visits, persisting at follow-up. In exploratory subgroup analyses, restricted to patients with higher abdominal pain and bloating scores at baseline, significant intragroup improvements in abdominal pain and bloating were observed with VSL#3® but not with placebo. Quality of life improvements were numerically greater and more sustained with VSL#3®. Conclusions: Within the limitations of the small sample size, these results show a signal of benefit in the quality of life of UC patients with IBS-like symptoms and suggest a potential complementary role for VSL#3® in symptom-oriented management, particularly for abdominal pain and bloating. Larger, adequately powered randomized trials are warranted to confirm these exploratory findings.
Clinical relevance
IBS-like symptoms are a recognized but undertreated complication in patients with ulcerative colitis (UC) who have achieved stable clinical and endoscopic remission, significantly impairing quality of life despite disease control. Current evidence for targeted pharmacological or probiotic interventions in this specific overlap phenotype remains sparse, leaving clinicians without clear guidance. This exploratory trial addresses that gap by evaluating the multistrain probiotic VSL#3® as a complementary, symptom-oriented strategy in a population frequently encountered in IBD clinics.
Key findings
1. Fifty-five adults with UC in stable remission for ≥6 months meeting Rome IV C1 or C4 IBS-like symptom criteria were randomized to VSL#3® 450 billion CFU twice daily versus placebo for 8 weeks — notably a small sample size that limits statistical power. 2. The primary endpoint — symptom relief at week 8 assessed by the 5-point Subject's Global Assessment of Relief scale — did not differ significantly between the VSL#3® and placebo groups (exact p-value not reported in the abstract). 3. Between-group differences in IBS-SSS total score at week 8 were not statistically significant; however, numerically greater and directionally consistent reductions in symptom severity and abdominal pain were observed with VSL#3® across all visit time points, including at post-treatment follow-up. 4. In pre-specified exploratory subgroup analyses restricted to patients with higher baseline abdominal pain and bloating scores, significant intragroup improvements in abdominal pain and bloating were observed with VSL#3® but not with placebo (between-group p-values not individually reported in the abstract). 5. Quality of life improvements, measured by IBS-QoL and IBDQ, were numerically greater and more sustained in the VSL#3® arm compared to placebo, though formal between-group statistical significance was not reported for these secondary endpoints. 6. Biochemical remission was monitored via fecal calprotectin; however, quantitative results and between-group comparisons for this endpoint were not detailed in the abstract.
Practice implications
For IBD clinicians managing UC patients in confirmed clinical and endoscopic remission who carry a residual burden of IBS-like symptoms — particularly prominent abdominal pain and bloating — VSL#3® 450 billion CFU twice daily for 8 weeks may offer a low-risk, complementary adjunct worth considering, especially in those with moderate-to-severe baseline pain and bloating scores where the signal of benefit appeared strongest. Clinicians should counsel patients that this remains exploratory evidence from an underpowered trial and that the primary endpoint was not met, so VSL#3® should not replace optimized maintenance IBD therapy or thorough exclusion of subclinical inflammation (via fecal calprotectin) before attributing symptoms to functional overlap. Larger, adequately powered RCTs are needed before formal guideline incorporation; in the interim, shared decision-making with symptom-burdened UC patients in remission is appropriate given the favorable safety profile of the intervention.