NCT04006977

Multistrain Probiotics Reduces UC Depression and Anxiety Scores

Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	a multistrain probiotic product (DSF)	In Arm 2, participants will receive standard medical therapy plus the multistrain probiotics (DSF), 4 sachets per day.
DIETARY_SUPPLEMENT	Placebo	In Arm 1, participants will receive standard medical therapy plus the placebo.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-02-01
• Completion: 2020-05-01
• First posted: 2019-07-05
• Last updated: 2019-09-12

Locations

1 site across 1 country: China