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Multistrain Probiotics Reduces UC Depression and Anxiety Scores

Primary Purpose

Ulcerative Colitis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

a multistrain probiotic product (DSF)

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring probiotics; psychological disorder;DSF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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:
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
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

Sites / Locations

Xijing Digestive Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 1: placebo plus standard therapy

Arm 2: DSF plus standard therapy

Arm Description

placebo plus standard therapy

DSF (4 sachets/day) plus standard therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical response

measured by a ≥1.5(3) points reduction in Simple Clinical Colitis Activity Index score at week 8 and 16

Clinical remission

measured by Simple Clinical Colitis Activity Index score ≤5(2) points at week 8 and 16

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

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.

Identification of potential stressors

Participants will be asked to complete a modified practical and family problem list to identify 13 potential stressors.

Adverse events

Adverse events were assessed at week 8 and 16 by patient survey.

Full Information

NCT ID

NCT04006977

First Posted

July 1, 2019

Last Updated

September 10, 2019

Sponsor

Xijing Hospital of Digestive Diseases

Collaborators

MENDES SA

1. Study Identification

Unique Protocol Identification Number

NCT04006977

Brief Title

Multistrain Probiotics Reduces UC Depression and Anxiety Scores

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 2019 (Anticipated)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

Collaborators

MENDES SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

probiotics; psychological disorder;DSF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: placebo plus standard therapy

Arm Type

Placebo Comparator

Arm Description

placebo plus standard therapy

Arm Title

Arm 2: DSF plus standard therapy

Arm Type

Experimental

Arm Description

DSF (4 sachets/day) plus standard therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

a multistrain probiotic product (DSF)

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

reduction of anxiety and depression scores

Description

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

Secondary Outcome Measure Information:

Title

Clinical response

Description

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

Title

Clinical remission

Description

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

Title

Endoscopic remission/response

Description

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

Title

Changes in fecal-associated microbiota following probiotic therapy

Description

Time Frame

0 week, 16 weeks

Title

Identification of potential stressors

Description

Participants will be asked to complete a modified practical and family problem list to identify 13 potential stressors.

Time Frame

0 weeks, 16 weeks

Title

Adverse events

Description

Adverse events were assessed at week 8 and 16 by patient survey.

Time Frame

4 weeks, 8 weeks, 12 weeks, 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Liang, Professor

Phone

86-029-85771535

liangjie@fmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Liang, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Digestive Disease

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

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Multistrain Probiotics Reduces UC Depression and Anxiety Scores

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