Gut MicrobiomeNCT07779265
Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being
A study testing Probiotic capsules in people with Gut Microbiome and Immune Responses, run by Orthomol Pharmazeutische Vertiebs GmbH at 1 site in Germany.
Trial summary
This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Immune Responses, Well-being
- What is being tested?
- Probiotic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer is healthy at the time of screening according to participant's own statements.
- TICS SSCS score ≥ 6.
- Male or female aged ≥18 and ≤65 years at the time of screening.
- BMI ≥18.5 and ≤29.9 kg/m².
- Volunteer is able and willing to comply with the study instructions.
- Volunteer is suitable for participation in the study according to the investigator/study personnel.
- Voluntary, written informed consent to participate in the study.
Who cannot join
- No command of local language.
- Currently diagnosed neurological or psychiatric disorders.
- Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
- Contraindication or allergy to any ingredient in the verum or Placebo product.
- Use of drugs in the previous 4 weeks before the beginning of intervention.
- Use of laxatives and labelled pre#and probiotics in the previous 2 weeks before the beginning of intervention.
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- Participation in another study with any investigational product within 30 days of screening, or less than five elimination half-lives after the last administration of the investigational product (whichever period is longer) or during the study.
- History of drug (recreational) or alcohol abuse.
- Bowel preparation for investigative procedures in the 4 weeks prior to screening.
- Surgical resection of any part of the bowel (excl. appendectomy).
- Pregnant or lactating female, or pregnancy planned during study period, or women of childbearing potential who are not using a medically approved form of contraception (at least three months prior to screening).
- Regular smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
daacro GmbH & Co.KG
Trier, 54290
Juliane Hellhammer, PhD, +49 651 9120 494, hellhammer@daacro.de
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Exploratory Study Assessing the Effects of Probiotic Supplementation on Gut Barrier Function, Immune Response, and Well-Being.
This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress.
50 participants will be randomly assigned to receive either a probiotic supplement or placebo for 8 weeks. Blood and stool samples will be collected before and after the intervention to assess markers of gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and immune function. Participants will also complete questionnaires on stress, quality of life, mood, digestive symptoms, and bowel habits. Safety will be evaluated throughout the study by monitoring adverse events and vital sign assessments.
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled, singlecenter, two-arm, parallel-group exploratory study in 50 healthy adults with mild to moderate levels of perceived stress.
The study lasts a total of 9 weeks per participant with a 1-week run-in period followed by 8 weeks of supplementation. The study includes three visits to the study site: a screening visit, a pre-intervention visit (at the end of the run-in period), and a post-intervention visit after 8 weeks of supplementation. After providing written informed consent, participants will undergo screening to confirm eligibility. Screening assessments include demographic information, medical history, concomitant medication, body weight, height, body mass index, blood pressure, pulse, and assessment of chronic stress. A pregnancy test will be performed for female participants, as applicable.
Participants are randomly assigned to receive either the probiotic supplement or a matching placebo. Randomization will be stratified by sex. Participants will take one capsule once daily before or with dinner for 56 days.
The probiotic product contains fructooligosaccharides, selected probiotic bacterial strains, and vitamins. The placebo does not contain those active ingredients and is similar in appearance, taste and smell. Treatment allocation will remain blinded to participants and the study team involved in study assessments. Blood and stool samples will be collected before and after the intervention. Laboratory assessments will include markers related to gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and systemic immune function. Further, participants will complete questionnaires assessing quality of life, health-related quality of life, depression, anxiety, stress, bloating, flatulence, stool consistency, and stool frequency. Safety will be evaluated by monitoring adverse events, blood pressure, and pulse. During the complete study duration, participants are instructed to maintain their usual lifestyle and diet.
- Conditions
- Gut Microbiome, Immune Responses, Well-being
- Being tested
- Probiotic capsules, Placebo
- Keywords
- RCT, Gut Barrier Function, Immune Response, Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic capsulesDietary supplement
Fructooligosaccharides, selected probiotic strains, vitamins
PlaceboOther
Maltodextrin, corn starch
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Supplement | Experimental | Fructooligosaccharides, selected probiotic strains, vitamins Receives: Dietary Supplement: Probiotic capsules |
| Placebo | Placebo comparator | Maltodextrin, corn starch Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut barrier function
Gut barrier function
Measured: During 8 week intake phase
Immune function
Immune function
Measured: During 8 week intake phase
Well-being
Perceived (health-related) quality of life, stress, anxiety, depression
Measured: During 8 weeks intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start13 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthomol Pharmazeutische Vertiebs GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daacro GmbH & Co. KG, Max-Planck-Str. 22, 54296 Trier/Germany
- Responsible party
- Sponsor
- Investigators
- Petra Scherenbacher, PhD, Study director, Orthomol pharmazeutische Vertriebs GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779265
- Sponsor's protocol ID
- Or02-2026
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Exploratory Study Assessing the Effects of Probiotic Supplementation on Gut Barrier Function, Immune Response, and Well-Being.
- ClinicalTrials.gov ID
- NCT07779265
- Acronym / sponsor ID
- Or02-2026
- Conditions
- Gut Microbiome, Immune Responses, Well-being
- Keywords
- RCT, Gut Barrier Function, Immune Response, Well-Being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Orthomol Pharmazeutische Vertiebs GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Daacro GmbH & Co. KG, Max-Planck-Str. 22, 54296 Trier/Germany
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 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.
This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress.
50 participants will be randomly assigned to receive either a probiotic supplement or placebo for 8 weeks. Blood and stool samples will be collected before and after the intervention to assess markers of gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and immune function. Participants will also complete questionnaires on stress, quality of life, mood, digestive symptoms, and bowel habits. Safety will be evaluated throughout the study by monitoring adverse events and vital sign assessments.
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled, singlecenter, two-arm, parallel-group exploratory study in 50 healthy adults with mild to moderate levels of perceived stress.
The study lasts a total of 9 weeks per participant with a 1-week run-in period followed by 8 weeks of supplementation. The study includes three visits to the study site: a screening visit, a pre-intervention visit (at the end of the run-in period), and a post-intervention visit after 8 weeks of supplementation. After providing written informed consent, participants will undergo screening to confirm eligibility. Screening assessments include demographic information, medical history, concomitant medication, body weight, height, body mass index, blood pressure, pulse, and assessment of chronic stress. A pregnancy test will be performed for female participants, as applicable.
Participants are randomly assigned to receive either the probiotic supplement or a matching placebo. Randomization will be stratified by sex. Participants will take one capsule once daily before or with dinner for 56 days.
The probiotic product contains fructooligosaccharides, selected probiotic bacterial strains, and vitamins. The placebo does not contain those active ingredients and is similar in appearance, taste and smell. Treatment allocation will remain blinded to participants and the study team involved in study assessments. Blood and stool samples will be collected before and after the intervention. Laboratory assessments will include markers related to gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and systemic immune function. Further, participants will complete questionnaires assessing quality of life, health-related quality of life, depression, anxiety, stress, bloating, flatulence, stool consistency, and stool frequency. Safety will be evaluated by monitoring adverse events, blood pressure, and pulse. During the complete study duration, participants are instructed to maintain their usual lifestyle and diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Supplement | Experimental | Dietary Supplement: Probiotic capsulesFructooligosaccharides, selected probiotic strains, vitamins |
| Placebo | Placebo comparator | Other: PlaceboMaltodextrin, corn starch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer is healthy at the time of screening according to participant's own statements.
- TICS SSCS score ≥ 6.
- Male or female aged ≥18 and ≤65 years at the time of screening.
- BMI ≥18.5 and ≤29.9 kg/m².
- Volunteer is able and willing to comply with the study instructions.
Key exclusion criteria (12 listed)
- No command of local language.
- Currently diagnosed neurological or psychiatric disorders.
- Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
- Contraindication or allergy to any ingredient in the verum or Placebo product.
- Use of drugs in the previous 4 weeks before the beginning of intervention.
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 |
|---|---|---|
| Probiotic capsulesFructooligosaccharides, selected probiotic strains, vitamins | Dietary supplement | Probiotic Supplement |
| PlaceboMaltodextrin, corn starch | Other | Placebo |
Primary outcome
Gut barrier function
Time frame: During 8 week intake phase
Gut barrier function
Immune function
Time frame: During 8 week intake phase
Immune function
Well-being
Time frame: During 8 weeks intervention phase
Perceived (health-related) quality of life, stress, anxiety, depression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
Petra Scherenbacher, PhD study director
Orthomol pharmazeutische Vertriebs GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic capsules in people with Gut Microbiome and Immune Responses, run by Orthomol Pharmazeutische Vertiebs GmbH 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Aug 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliane Hellhammer, PhD (+49 651 9120 494, hellhammer@daacro.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut barrier function (time frame: During 8 week intake phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.