Changes in Human Gut Microbiome in Healthy AdultsNCT07450807
Prospective Randomized Controlled Pilot Study of Gut Microbiome Modulation by Nigella Sativa Seed Oil and Thymoquinone Metabolism in Healthy Volunteers
A study testing Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules in people with Changes in Human Gut Microbiome in Healthy Adults, run by Aysun Tekbaş at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Changes in Human Gut Microbiome in Healthy Adults
- What is being tested?
- Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 2 Apr 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no recent medication use
- no history of gastrointestinal surgery
- no pregnancy
- no allergies to NSSO or its derivatives
- healthy
- 18 years and above
Who cannot join
- regular medication
- history of gastrointestinal surgery
- pregnancy
- allergies to NSSO or its derivates
- presence of chronic illness
- below the age of 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Thymoquinone on the Human Gut Microbiome
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.
- Being tested
- Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules
- Keywords
- Thymoquinone, Gut microbiome, Nigella sativa seed oil, Microbiota modulation, Thymoquionone metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsulesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Intake of two TQ-containing NSSO capsules three times daily for 20 days and fecal sampling at five time points. Receives: Dietary Supplement: Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules |
| Control group | No intervention | Fecal sampling at five time points without supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bacterial taxa in fecal samples
Measured: From enrollment to the end of treatment at 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start2 Apr 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Changes in Human Gut Microbiome in Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysun Tekbaş
- Sponsor type
- University, hospital or other
- Collaborators
- Interdisciplinary Center of Clinical Research of the Medical Faculty Jena
- Responsible party
- Sponsor-investigator, Aysun Tekbaş, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450807
- Sponsor's protocol ID
- 2024-3273-BO
- Other IDs
- ACSP08
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The microbiome datasets will be shared online.
Publications
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.
PubMed 29621129Tekbas 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.
PubMed 38003621El-Banna AF, Junca H, Steube A, Wissenbach DK, Settmacher U, Schneider C, Tekbas A. A prospective randomized controlled pilot study of gut microbiome modulation by Nigella sativa seed oil and thymoquinone metabolism in healthy volunteers: implications for gastrointestinal surgery. Sci Rep. 2026 Sep 15;16(1):28704. doi: 10.1038/s41598-026-69567-3.
PubMed 42744850
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Thymoquinone on the Human Gut Microbiome
- ClinicalTrials.gov ID
- NCT07450807
- Acronym / sponsor ID
- 2024-3273-BO
- Keywords
- Thymoquinone, Gut microbiome, Nigella sativa seed oil, Microbiota modulation, Thymoquionone metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aysun TekbaşUniversity, hospital or other
- Collaborators
- Interdisciplinary Center of Clinical Research of the Medical Faculty Jena
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsulesIntake of two TQ-containing NSSO capsules three times daily for 20 days and fecal sampling at five time points. |
| Control group | No intervention | –Fecal sampling at five time points without supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- no recent medication use
- no history of gastrointestinal surgery
- no pregnancy
- no allergies to NSSO or its derivatives
- healthy
Key exclusion criteria (6 listed)
- regular medication
- history of gastrointestinal surgery
- pregnancy
- allergies to NSSO or its derivates
- presence of chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsulesIntake 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. | Dietary supplement | Treatment group |
Primary outcome
Changes in bacterial taxa in fecal samples
Time frame: From enrollment to the end of treatment at 20 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 29621129Tekbas 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.
- Results publication: PubMed 38003621Tekbas 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.
- Derived from this study: PubMed 42744850El-Banna AF, Junca H, Steube A, Wissenbach DK, Settmacher U, Schneider C, Tekbas A. A prospective randomized controlled pilot study of gut microbiome modulation by Nigella sativa seed oil and thymoquinone metabolism in healthy volunteers: implications for gastrointestinal surgery. Sci Rep. 2026 Sep 15;16(1):28704. doi: 10.1038/s41598-026-69567-3.
- Individual participant dataSharing planned: Yes. The microbiome datasets will be shared online.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules in people with Changes in Human Gut Microbiome in Healthy Adults, run by Aysun Tekbaş at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bacterial taxa in fecal samples (time frame: From enrollment to the end of treatment at 20 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07450807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.