This pilot study aims to evaluate the effect of a 16-week duration of multistrain probiotic product (De Simone Fomulation (DSF), previously known as VSL#3 and now available as Vivomixx in EU and Visbiome in USA to reduce anxiety and depression scores in mild to moderate active UC. It has been known that gut microbiota is associated with IBD and mental health. In addition, IBD patients complicated with psychiatric disorders are rising more and more attention. Further, a recent study "Probiotic Bifidobacterium longum NCC3001 Reduces Depression Scores and Alters Brain Activity: A Pilot Study in Patients With Irritable Bowel Syndrome" was published in Gastroenterology in 2017, thus we wonder if DSF have an effect on the depression/anxiety in patients with UC)A total of 60 patients will be randomly allocated into two groups, group A will receive standard medical therapy plus placebo (4 sachets/day,), and group B will receive standard medical therapy plus DSF (each sachet containing 450 billion CFU, eight bacterial strains 4 sachets/day) for 16 weeks. The primary endpoint is the reduction of anxiety and depression scores after treatment (at 8 weeks and 16 weeks) using hospital anxiety and depression scale (HADS). The secondary endpoints including clinical response after 8-week and 16-week treatment (measured by a ≥3-point reduction in a Simple Clinical Colitis Activity Index (SCCAI) score at 16 weeks), and clinical remission (defined as SCCAI score ≤5 at 8 weeks and 16 weeks). Changes in fecal-associated microbiota by 16S ribosomal RNA sequencing and metabolomics using company service following probiotics therapy (at 16 weeks) were also assessed, stratified by both change in SCCAI score following probiotics therapy and randomization. Adverse events were evaluated at week 8 and 16 weeks by patient survey
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
In Arm 2, participants will receive standard medical therapy plus the multistrain probiotics (DSF), 4 sachets per day.
In Arm 1, participants will receive standard medical therapy plus the placebo.
Xijing Digestive Disease
Xi'an, Shaanxi, China
reduction of anxiety and depression scores
reduction of anxiety and depression scores (with points as standard units) using HADS at 8 weeks and 16 weeks after randomized treatment
Time frame: 0 week, 8 weeks, 12 weeks, 16 weeks
Clinical response
measured by a ≥1.5(3) points reduction in Simple Clinical Colitis Activity Index score at week 8 and 16
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
Clinical remission
measured by Simple Clinical Colitis Activity Index score ≤5(2) points at week 8 and 16
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
Endoscopic remission/response
measured by a Mayo endoscopic subscore of \<1 point, or at least a 1 point reduction from baseline in the endoscopy subscore at week 16
Time frame: 0 week, 16 weeks
Changes in fecal-associated microbiota following probiotic therapy
Changes in fecal-associated microbiota using16S ribosomal RNA sequencing and changes in the metabolomic profile of the feces following probiotic therapy (at baseline and 16 weeks) will be assessed, stratified by both change in Simple Clinical Colitis Activity Index score following probiotic therapy and randomization.
Time frame: 0 week, 16 weeks
Identification of potential stressors
Participants will be asked to complete a modified practical and family problem list to identify 13 potential stressors.
Time frame: 0 weeks, 16 weeks
Adverse events
Adverse events were assessed at week 8 and 16 by patient survey.
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.