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| ID | Type | Description | Link |
|---|---|---|---|
| ACSP08 | Other Grant/Funding Number | Interdisciplinary Center of Clinical Research, Medical Faculty of Friedrich Schiller Universit |
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| Name | Class |
|---|---|
| Interdisciplinary Center of Clinical Research of the Medical Faculty Jena | UNKNOWN |
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For many patients, the additive use of dietary supplements without side effects is motivating for therapy and enhances quality of life. The oil of the plant Nigella sativa (NS), a dietary supplement containing Thymoquinone (TQ) as its main active compound, exhibits hepatoprotective effects through antioxidative, antifibrotic, and anti-inflammatory properties, and also demonstrates anticancer and antiapoptotic activities. In vitro and in vivo studies have shown that TQ can also influence the gut microbiome. However, no clinical studies are currently available that describe the specific extent of TQ's influence on the human intestinal microbiome and its potential effects on the outcome after gastrointestinal surgery.
The aim of the project is therefore to investigate changes in the human microbiome following the intake of Nigella sativa seed oil capsules containing TQ as the main active ingredient. The study will test the hypothesis that TQ, through its diverse mechanisms of action, modulates the composition of the microbiome and thereby exerts a positive effect on immune response and intestinal healing processes. In parallel, TQ metabolites in urine will be analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) to gain insights into the pharmacokinetic profile of the compound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Intake of two TQ-containing NSSO capsules three times daily for 20 days and fecal sampling at five time points. |
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| Control group | No Intervention | Fecal sampling at five time points without supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules | Dietary Supplement | Intake of two Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules three times daily for 20 days and provision of fecal samples at five time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bacterial taxa in fecal samples | From enrollment to the end of treatment at 20 days. |
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Inclusion Criteria:
Exclusion Criteria:
male and female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jena University Hospital | Jena | Thuringia | 07747 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29621129 | Result | Tekbas A, Huebner J, Settmacher U, Dahmen U. Plants and Surgery: The Protective Effects of Thymoquinone on Hepatic Injury-A Systematic Review of In Vivo Studies. Int J Mol Sci. 2018 Apr 5;19(4):1085. doi: 10.3390/ijms19041085. | |
| 38003621 | Result | Tekbas A, Bremer-Streck S, Wissenbach DK, Peters FT, von Lilienfeld-Toal M, Soonawalla Z, Rauchfuss F, Settmacher U, Dahmen U. Gas Chromatography-Mass Spectrometry Detection of Thymoquinone in Oil and Serum for Clinical Pharmacokinetic Studies. Int J Mol Sci. 2023 Nov 17;24(22):16431. doi: 10.3390/ijms242216431. |
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The microbiome datasets will be shared online.
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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