Multistrain Probiotics Reduces UC Depression and Anxiety Scores

NCT ID: NCT04006977

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2020-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: placebo plus standard therapy

placebo plus standard therapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Arm 2: DSF plus standard therapy

DSF (4 sachets/day) plus standard therapy

Group Type: EXPERIMENTAL

a multistrain probiotic product (DSF)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

a multistrain probiotic product (DSF)

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged ≥18

2. 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)

3. Patients with psychological dysfunction at screening based on hospital anxiety and depression scale (HADS), defined as HAD-A or HAD-D score ≥ 8

4. Signed Informed Consent obtained

Exclusion Criteria

1. Severe ulcerative colitis (SCCAI score ≥ 12) or toxic dilatation of the colon

2. Prior bowel (either intestine or colon) resection surgery

3. 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.

4. Take the following treatment:

1. Antibiotics within 4 weeks prior to screening

2. Oral steroids within the past 4 weeks before screening

3. Acetyl-salicylic acid ≤100 mg/day as anti-platelet therapy or NSAIDs within 4 weeks prior screening

4. Consecutive consumption of probiotics in 4 weeks prior to enrollment

5. Topical or oral steroids within the past 4 weeks before screening

5. Patients requiring hospitalization or imminent need for surgery

6. Significant hepatic function abnormalities, defined as the values of serum ALT or AST ≥twice of the upper limit of normal value

7. Women who are planning or actual pregnancy or lactating during study period

8. Alcohol addiction (>40 g of alcohol/day，equivalent to >1 L of beer/day, 0.5 L of wine/day)

9. 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

10. Patients participating or having participated in another clinical study 30 days prior to screening

11. Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease

12. Patients who are unwilling to comply with the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MENDES SA

UNKNOWN

Sponsor Role: collaborator

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Jie Liang

Professor of Gastroenterology Dept.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Liang, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Xijing Digestive Disease

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Jie Liang, Professor

Role: CONTACT

liangjie@fmmu.edu.cn

86-029-85771535

References

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 Jul 9:1-12. doi: 10.1080/1028415X.2025.2527224. Online ahead of print.

Reference Type: DERIVED

PMID: 40629893 (View on PubMed)

Other Identifiers

XijingHDD-UC-Probiotics

Identifier Type: -

Identifier Source: org_study_id