Multistrain Probiotics Reduces UC Depression and Anxiety Scores

NCT04006977 | Unknown

• 1 other identifier: XijingHDD-UC-Probiotics
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

probiotics; psychological disorder;DSF

Outcome Measures

Primary Outcomes (1)

• 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

  0 week, 8 weeks, 12 weeks, 16 weeks

Secondary Outcomes (6)

• Clinical response

  4 weeks, 8 weeks, 12 weeks, 16 weeks

• Clinical remission

  4 weeks, 8 weeks, 12 weeks, 16 weeks

• Endoscopic remission/response

  0 week, 16 weeks

• Changes in fecal-associated microbiota following probiotic therapy

  0 week, 16 weeks

• Identification of potential stressors

  0 weeks, 16 weeks

Study Arms (2)

Arm 1: placebo plus standard therapy

PLACEBO COMPARATOR

placebo plus standard therapy

Dietary Supplement: Placebo

Arm 2: DSF plus standard therapy

EXPERIMENTAL

DSF (4 sachets/day) plus standard therapy

Dietary Supplement: a multistrain probiotic product (DSF)

Interventions

a multistrain probiotic product (DSF) DIETARY_SUPPLEMENT

In Arm 2, participants will receive standard medical therapy plus the multistrain probiotics (DSF), 4 sachets per day.

Also known as: De Simone Fomulation (DSF), previously known as VSL#3 and now available as Vivomixx in EU and Visbiome in USA

Arm 2: DSF plus standard therapy

Placebo DIETARY_SUPPLEMENT

In Arm 1, participants will receive standard medical therapy plus the placebo.

Arm 1: placebo plus standard therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥18
• Patients with mild-to-moderately active UC (defined as a SCCAI score of ≥ 5 and \< 12 and a colonoscopy will be performed to confirm the classification)
• Patients with psychological dysfunction at screening based on hospital anxiety and depression scale (HADS), defined as HAD-A or HAD-D score ≥ 8
• Signed Informed Consent obtained

You may not qualify if:

• Severe ulcerative colitis (SCCAI score ≥ 12) or toxic dilatation of the colon
• Prior bowel (either intestine or colon) resection surgery
• Patients with any other disease or condition which might interfere with their participation in the trial, including significant hepatic, renal, endocrine, respiratory, neurologic, immune deficiency, cardiovascular, malignant diseases, bleeding disorders, autoimmune diseases and schizophrenia.
• Take the following treatment:
• Antibiotics within 4 weeks prior to screening
• Oral steroids within the past 4 weeks before screening
• Acetyl-salicylic acid ≤100 mg/day as anti-platelet therapy or NSAIDs within 4 weeks prior screening
• Consecutive consumption of probiotics in 4 weeks prior to enrollment
• Topical or oral steroids within the past 4 weeks before screening
• Patients requiring hospitalization or imminent need for surgery
• Significant hepatic function abnormalities, defined as the values of serum ALT or AST ≥twice of the upper limit of normal value
• Women who are planning or actual pregnancy or lactating during study period
• Alcohol addiction (\>40 g of alcohol/day，equivalent to \>1 L of beer/day, 0.5 L of wine/day)
• Patients with a history of a psychiatric condition other than anxiety or depression, use of opioids, antidepressants or anxiolytics in regular doses, illicit drug consumption
• Patients participating or having participated in another clinical study 30 days prior to screening

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead
• MENDES SA: collaborator

Study Sites (1)

Xijing Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Liu X, Zhou H, Zhang J, Li R, Liang J. Brain-gut co-management: probiotic LAB improves mental health and further reduces disease activity in ulcerative colitis patients with emotional disturbance. Nutr Neurosci. 2025 Dec;28(12):1511-1522. doi: 10.1080/1028415X.2025.2527224. Epub 2025 Jul 9.

  PMID: 40629893 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jie Liang, Professor

  Hospital of Digeetive Disease, Xi'an, Shaanxi, Xijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Liang, Professor

CONTACT

86-029-85771535; liangjie@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology Dept.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: October 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

CN (1)