Multistrain Probiotics Reduces UC Depression and Anxiety Scores

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04006977
• Date of registration: 01/07/2019
• Prospective Registration: Yes
• Primary sponsor: Xijing Hospital of Digestive Diseases
• Public title: Multistrain Probiotics Reduces UC Depression and Anxiety Scores
• Scientific title: Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis
• Date of first enrolment: October 2019
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04006977
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Jie Liang, Professor

• Name: Jie Liang, Professor
• Affiliation: Hospital of Digeetive Disease, Xi'an, Shaanxi, Xijing, China

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: a multistrain probiotic product (DSF)

Primary Outcome(s)

reduction of anxiety and depression scores [Time Frame: 0 week, 8 weeks, 12 weeks, 16 weeks]

Secondary Outcome(s)

Adverse events [Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks]

Endoscopic remission/response [Time Frame: 0 week, 16 weeks]

Clinical response [Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks]

Identification of potential stressors [Time Frame: 0 weeks, 16 weeks]

Changes in fecal-associated microbiota following probiotic therapy [Time Frame: 0 week, 16 weeks]

Clinical remission [Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks]

Secondary ID(s)

XijingHDD-UC-Probiotics

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MENDES SA