Impact of nutritional supplementation of Bacillus megaterium DSM 32963 and an omega-3-polyunsaturated-fatty-acid-lysin complex in Ulcerative Colitis, a double-blind, placebo-controlled pilot proof-of-concept study

Not Applicable

Recruiting

Conditions: K51
Ulcerative colitis

Registration Number: DRKS00033433

Lead Sponsor: Evonik Operations GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

patients with
-established mild/moderate ulcerative colitis (grade 2/3) in treatment with 5ASA (mesalazine) and not currently or previously treated with biologic agents or steroids
-who accept to undergo the study after informed consent
-if woman in childbearing age, adequate contraception in place
-Concomitant treatments, such as treatment for blood pressure, osteoporosis, and iron / vitamin supplements are only permitted if the therapy is stable and will likely not be discontinued during the study.

Exclusion Criteria

-pregnancy
-any concomitant chronic disease or condition requiring steroids or NSAIDs therapy
-diabetes
-severe disease activity
-unable to give informed consent.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to day 28 fecal inflammatory marker calprotectin (day 0, day 28) and comparison to placebo<br>Pilotstudy, further endpoints listed in secondary outcomes.

Secondary Outcome Measures

Name	Time	Method
- Endoscopy and histology grading, Mayo Score (day 0, day 28)<br>- Inflammatory Bowel Disease Questionnaire (IBDQ) (day 1, day 14, day 28)<br>- Simple Clinical Colitis Activity Index (SCCAI) (day 1, day 14, day 28) <br>- Inflammatory mediators in blood: CRP, IL-1beta; IL-6; IL-4; IL-23; IFa, IFy and TNF- a (day 0, day 14, day 28)<br>- Colon biopsy (day 0, day 28)