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

Effect of oral Curcumin on Gut Microbiota Composition in patients with Diabetes Type II, Ulcerative Colitis, Crohn's disease and healthy subjects - Effect of oral curcumin on gut microbiota in various patient populations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52653

Enrollment

Registered

2020-11-09

Start date

2021-11-24

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease Diabetes Type II Ulcerative Colitis

Interventions

3 gram oral curcumin twice a day over a period of 8 weeks. This will be accompanied with a glucose sensor (Free Style Libre) two weeks before and last two weeks of intervention for all patients grou

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
- Fecal gutmicrobiota composition (as determined by 16S sequencing) at three timepoints being baseline, visit week 4 and visit week 8. - changes in fecal SCFA metabolites at these three timepoints - the fecal, urine and plasma (gutmicrobiota derived) curcumin metabolites at these three timepoints	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)