Effect of oral Curcumin on Gut Microbiota Composition in patients with Diabetes Type II, Ulcerative Colitis, Crohn's disease and healthy subjects

Recruiting

Conditions: Ulcerative Colitis
Diabetes Type II
10012653
Crohn's Disease
10017969

Registration Number: NL-OMON52653

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Aged 18-65 years
- Stable therapy (i.e. no major dosage changes in the last three months)
- Able to give written informed consent

Exclusion Criteria

- Tobacco use (as there are indications this influences the gut microbiota,
Huang et al. 2019)
- Alcohol use > 1 units/day,
- Excessive weight loss of >10% in the last 3 months,
- Levels of plasma aspartate aminotransferase (ASAT) and alanine
aminotransferase (ALAT) 2.5 times or more the upper limit of the normal range,
- Other liver abnormalities,
- Known intolerance to curcumin or curcumin-derivatives,
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS),
- Use of proton pump inhibitors (as this influences intestinal microbiota
composition)
- Incomplete information or unwillingness to comply with the intervention,
- Participation in other intervention studies 3 months before or after the
duration of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Any changes in continuous glucose monitoring (CGM, Free Style Libre) before and<br /><br>at end of study. Also, fasting glucose, insulin levels, HOMA, Hba1c, lipid<br /><br>profile including LDL-cholesterol (diabetes type II patients) will be studied<br /><br>together with disease changes in SSCAI and HBI scores (ulcerative colitis and<br /><br>Crohn*s disease) and changes in fecal calprotectin. Changes in the<br /><br>inflammatory response will be assessed by measuring the changes in levels of<br /><br>inflammatory markers (calprotectin, hemoglobin, hematocrit, MCV, Leucocytes,<br /><br>thrombocytes, CRP, albumine, ironstatus (iron, ferritin, TYBC), bilirubin,<br /><br>ASAT, ALAT, AF, y-GT, creatinine).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Fecal gutmicrobiota composition (as determined by 16S sequencing) at three<br /><br>timepoints being baseline, visit week 4 and visit week 8.<br /><br>- changes in fecal SCFA metabolites at these three timepoints<br /><br>- the fecal, urine and plasma (gutmicrobiota derived) curcumin metabolites at<br /><br>these three timepoints</p><br>