An interventional study of Vivomixx® powder and Placebo powder in Depressive Symptoms, Anxiety and Stress, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Basic science
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Among 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf — 2 open to participants now, 3 under way, none of them phase 3. Depression · Universitätsklinikum Hamburg-Eppendorf.
Among the 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf, this one is the 19th largest by enrollment of the 23 interventional ones that give a count, is one of 4 that started in 2018, is one of 23 with no phase, and was the 13th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →2 of the 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf are open now, in 1 country. Recruiting first, the newest first:
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 60+ · Healthy volunteers
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 12–17
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · healthy volunteers too.
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24 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2018.
This study's enrollment of 59 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 127 across the 23 interventional studies, 300 across the 1 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
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Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
1 of the studies in Depression by Universitätsklinikum Hamburg-Eppendorf that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06831994Universitätsklinikum Hamburg-EppendorfDigital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity | 2027-02-28 |
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Among the 24 studies in Depression by Universitätsklinikum Hamburg-Eppendorf, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Theory and research on the gut-brain-axis emphasize complex interactions between the gut microbiota, immunological and hormonal responses, brain function, brain structure, as well as resulting behavioral manifestations, such as cognitive functions and mental illness. Probiotics are living micro-organisms that change the composition of the gut microbiota and hypothetically have a positive effect on the host's general health and well-being. Probiotic bacteria naturally occur in foods such as Sauerkraut, olives, and dark chocolate, and are currently also added to industrial products such as yogurt.
Regarding the effect of probiotics on brain structure and function, animal studies have shown that the administration of probiotics in mice and rats was linked to neurogenesis in the hippocampus and an improvement of associated cognitive functions. The majority of these studies applied probiotics for 4 weeks. The substances used in these studies were often composed of several bacterial strains, suggesting that the neurogenic effect may not be reducible to a specific type of probiotic bacteria.
Probiotics seem to be effective in improving memory abilities, including spatial and non-spatial memory, both in rodents and humans. Moreover, specifically regarding the beneficial effect of probiotics on anxiety, depression and stress, preliminary evidence in humans is compelling. However methodologically sound (randomized-controlled trial [RCT], 'blind') studies are still lacking.
To sum up, the present study is going to be the first RCT with human participants that investigates structural and functional changes of the hippocampus through probiotic bacteria, using Magnet Resonance Imaging (MRI). In addition, the study aims at advancing research in the field by investigating the effects of probiotics on a broad spectrum of cognitive functions, particularly those associated with hippocampal activity (e.g. spatial memory, verbal memory). Furthermore, effects on several types of mental illness (e.g. anxiety, depression, stress) will be studied. Potential translatory mechanisms that may promote the aforementioned effects will be examined, i.e. changes in immunological parameters, 'brain derived neurotrophic factor' (BDNF), and oxytocin.
A double-blind RCT intervention study will be conducted to investigate the effect of a probiotic dietary supplement vs. a placebo, taken by healthy human participants (N = 60) for 28 consecutive days. Both substances are administered in doses of 4.4g (powder) per day.
The probiotic dietary supplement used in the present study is a freely available product (in powder form) sold under the name of Vivomixx®. Per 4.4g the powder contains 450 billion bacteria, composed of eight bacterial strains: Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L.delbrueckii subsp. bulgaricus), Bifidobacteria (B. longum, B. infantis, B. breve), and Streptococcus thermophiles.
This product was chosen, because a similar supplement with an identical composition of bacteria as Vivomixx® was found to be linked to hippocampal neurogenesis in mice. The placebo powder has a similar taste and consistency as the verum (Vivomixx®) powder, but contains no probiotic bacteria.
First, participants will be screened online for eligibility (T0). Before and after the 28-day intake period, participants are asked to perform several cognitive tests and fill out questionnaires (T1, T2) at our laboratory (ca. 2 - 2.5 hours). Afterwards, blood samples will be drawn (ca. 5 minutes) and a magnet resonance tomography (MRT) session (ca. 1 - 1.5 hours) will be conducted, where participants will perform an object pattern separation task in the scanner (T1, T2). Furthermore, a follow-up after 2 months (T3), including the same assessments as at T1 and T2, will be conducted.
During the intake period participants will fill out a brief questionnaire on a weekly basis, which includes an assessment of state depression and anxiety, defecation (control item to rule out adverse effects), recent (start of) intake of medication, recent (onset of) intake of antibiotics, and recent inter-current illness (e.g. influenza). In addition, participants will record their food intake (protocol) for one week (7 consecutive days) during the intake period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The verum condition probiotics in the present study is a freely available product, Vivomixx® powder (dietary supplement). Each dose (4.4g) contains 450 billion bacteria, composed of eight bacterial strains: Lactobacilli (L. paracasei, L. plantarum, L. acidophilus, L.delbrueckii subsp. bulgaricus), Bifidobacteria (B. longum, B. infantis, B. breve), and Streptococcus thermophiles. 30 Participants will be randomly assigned to this condition. The intake period is 28 days, daily dose = 4.4g.
Dietary Supplement: Vivomixx® powder
In the placebo condition participants will receive a placebo powder (comparable in taste and consistency to Vivomixx® = verum condition probiotics) that contains no probiotic bacteria. 30 Participants will be randomly assigned to that condition. The intake period is 28 days, daily dose = 4.4g.
Other: Placebo powder
Participants will take in a daily dose of 4.4g for 28 consecutive days
Also known as: probiotic dietary supplement
Participants will take in a daily dose of 4.4g for 28 consecutive days
Changes in hippocampal volume, assessed via Magnet Resonance Imaging (MRI)
changes in hippocampal volume in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in functional brain activation during fMRI task
changes in functional connectivity (using BOLD signal) in hippocampal regions in verum experimental group (in comparison to placebo control) during pattern separation fMRI task
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in depression
changes in levels of depression, assessed with Beck's Depression Inventory - II Revised (BDI-II-R) sum score in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in spatial navigation
changes in test performance scores (number of correct responses, degree of accuracy measured as position hits) in the Tunnel task in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Interleukin-6 (IL-6)
changes in IL-6 blood serum concentration levels in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in IL-1ß
changes in IL-1ß blood serum concentration levels in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Tumor Necrosis Factor alpha (TNF-alpha)
changes in TNF-alpha blood serum concentration levels in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Brain Derived Neurotrophic Factor (BDNF)
changes in blood serum level concentration of BDNF in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in verbal learning test performance
changes in verbal learning performance score, assessed with the Verbal Learning Memory Test (VLMT) in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in pattern separation fMRI task
changes in the pattern separation task performance (no. of correct responses to picture stimuli) in in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Oxytocin (OXT)
changes in blood serum concentration levels of OXT in verum experimental group (in comparison to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Processing speed or performance IQ
changes in processing speed assessed by a digit-symbol test (BIS; Berliner Intelligenzskala) in verum experimental group (as compared to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in cognitive emotion regulation - functional emotion regulation
changes in functional emotion regulation questionnaire sum score (as assessed with the Cognitive Emotion Regulation Questionnaire; CERQ) in verum experimental group (as compared to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Sleepiness
changes in sleepiness questionnaire sum score (ESS; Epworth Sleepiness Scale) scores in verum experimental group (as compared to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in cognitive emotion regulation - dysfunctional emotion regulation
changes in dysfunctional emotion regulation questionnaire sum score (as assessed with the Cognitive Emotion Regulation Questionnaire; CERQ) in verum experimental group (as compared to placebo control)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Plan to share: No
Ran from Jan 2018 to primary completion in Nov 2019, 22 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 22 months is close to that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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