Ulcerative ColitisNCT04006977
Multistrain Probiotics Reduces UC Depression and Anxiety Scores
A study testing a multistrain probiotic product (DSF) in people with Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- a multistrain probiotic product (DSF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
- Patients who are unwilling to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis
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
- Being tested
- a multistrain probiotic product (DSF), Placebo
- Keywords
- probiotics; psychological disorder;DSF
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a multistrain probiotic product (DSF)Dietary supplement
Also called De Simone Fomulation (DSF), previously known as VSL#3 and now available as Vivomixx in EU and Visbiome in USA
In Arm 2, participants will receive standard medical therapy plus the multistrain probiotics (DSF), 4 sachets per day.
PlaceboDietary supplement
In Arm 1, participants will receive standard medical therapy plus the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: placebo plus standard therapy | Placebo comparator | placebo plus standard therapy Receives: Dietary Supplement: Placebo |
| Arm 2: DSF plus standard therapy | Experimental | DSF (4 sachets/day) plus standard therapy Receives: Dietary Supplement: a multistrain probiotic product (DSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 week, 8 weeks, 12 weeks, 16 weeks
Secondary outcomes (6)
Clinical response
measured by a ≥1.5(3) points reduction in Simple Clinical Colitis Activity Index score at week 8 and 16
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 0 weeks, 16 weeks
Adverse events
Adverse events were assessed at week 8 and 16 by patient survey.
Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startOct 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- MENDES SA
- Responsible party
- Principal investigator, Jie Liang, Xijing Hospital of Digestive Diseases
- Investigators
- Jie Liang, Professor, Principal investigator, Hospital of Digeetive Disease, Xi'an, Shaanxi, Xijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006977
- Sponsor's protocol ID
- XijingHDD-UC-Probiotics
- Status last verified
- Sep 2019
- First submitted
- 1 Jul 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40629893
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04006977
- Acronym / sponsor ID
- XijingHDD-UC-Probiotics
- Conditions
- Ulcerative Colitis
- Keywords
- probiotics; psychological disorder;DSF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Collaborators
- MENDES SA
- Study start
- Oct 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: placebo plus standard therapy | Placebo comparator | Dietary Supplement: Placeboplacebo plus standard therapy |
| Arm 2: DSF plus standard therapy | Experimental | Dietary Supplement: a multistrain probiotic product (DSF)DSF (4 sachets/day) plus standard therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Patients requiring hospitalization or imminent need for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a multistrain probiotic product (DSF)Also: De Simone Fomulation (DSF), previously known as VSL#3 and now available as Vivomixx in EU and Visbiome in USAIn Arm 2, participants will receive standard medical therapy plus the multistrain probiotics (DSF), 4 sachets per day. | Dietary supplement | Arm 2: DSF plus standard therapy |
| PlaceboIn Arm 1, participants will receive standard medical therapy plus the placebo. | Dietary supplement | Arm 1: placebo plus standard therapy |
Primary outcome
reduction of anxiety and depression scores
Time frame: 0 week, 8 weeks, 12 weeks, 16 weeks
reduction of anxiety and depression scores (with points as standard units) using HADS at 8 weeks and 16 weeks after randomized treatment
6 secondary outcomes
Clinical response
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
Clinical remission
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
Endoscopic remission/response
Time frame: 0 week, 16 weeks
Changes in fecal-associated microbiota following probiotic therapy
Time frame: 0 week, 16 weeks
Identification of potential stressors
Time frame: 0 weeks, 16 weeks
Adverse events
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 40629893Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Liang, Professor principal investigator
Hospital of Digeetive Disease, Xi'an, Shaanxi, Xijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a multistrain probiotic product (DSF) in people with Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Liang, Professor (86-029-85771535, liangjie@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of anxiety and depression scores (time frame: 0 week, 8 weeks, 12 weeks, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.