Depression, AnxietyNCT03539263
Effects of Probiotics on Mood
A study testing Bifihappy in people with Depression, Anxiety, run by Probiotical S.p.A. at 1 site in Italy.
Trial summary
Recent demonstration that probiotics administration has positive effects on depressive feelings in healthy populations suggests its possible role as an adjuvant therapy for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Bifihappy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2016to 15 Jun 2017
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Famale subjects.
- Aged between 18 and 35.
- Already owing a smartphone with Android or iOS system.
Who cannot join
- Drug taking, smoking, coeliac disease, lactose intolerance.
- Disorders such as IBS (Irritable Bowel Syndrome), IBD (Irritable Bowel Disease), UC (Ulcerative Colitis) and other serious diseases, e.g. MS (Multiple Sclerosis) and diabetes (type 1/type 2).
- Oral intake of antibiotics and other medicines on a continuative basis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Experimental Trial Designed to Test the Effects of Probiotics on Mood
Recent demonstration that probiotics administration has positive effects on depressive feelings in healthy populations suggests its possible role as an adjuvant therapy for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. The present study extends current knowledge on the beneficial effects of probiotics on psychological well-being, as measured by changes in mood (e.g., depression, anxiety, cognitive reactivity to sad mood), personality dimensions, and quality of sleep, which have been considered as related to mood. For this double-blind, placebo-controlled study healthy volunteers pseudo-randomly assigned to an experimental or control group assumed a daily dose of probiotic or placebo, respectively, for 6 weeks. Mood, personality dimensions, and sleep quality were assessed four times (before the beginning of the study, at 3 and 6 weeks, and at 3 weeks of washout).
Read the detailed description
- THEORETICAL BACKGROUND The intestine and the brain are intimately connected with each other through the gut-brain axis, which involves bidirectional communication between the nervous, endocrine and immune systems. In the last years, it has become increasingly evident that this communication implies also interactions with the intestinal bacterial flora, which releases immune activation and other signalling molecules that may play a major role in the regulation of the brain and human behaviour. For instance, the microbiota produces neuroactive substances and their precursors (e.g. tryptophan) that may reach the brain through the endocrine and autonomous nervous system. Recently, the interest has been focused also on the cognitive field. Indeed, there is experimental evidence that bacterial products may positively influence cognitive functions, such as spatial memory and problem-solving abilities. Moreover, probiotics seem to exercise influence on mood, anxiety and depression, opening new therapeutic prospects. A recent trial showed that four weeks of taking probiotics (Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 e W58) led to an improvement in mood, fostering reduction in negative thoughts.
- THE PURPOSE OF THE RESEARCH PROJECT The primary goal of the trial is to investigate the effect of probiotics on depression. Moreover, it will assess also effects on anxiety and other personality traits in healthy young students. The trial intends also to investigate whether probiotics may influence the quality of sleep and bowel habits. The trial will be placebo-controlled, randomized, pre- and post-intervention, double-blind designed (investigator and participants). In the light of the several end-points examined, the statistical analysis will be of explorative type.
The collection of faecal samples will allow, in case of finding any effects of the administered product on mood, to go back to any microbial components that have changed in individuals following the treatment. Monitoring (see below) the normal feed and physical habits of the individuals will allow to check the possible effect of these confounding factors on the parameters measured in the trial.
- Conditions
- Depression, Anxiety
- Being tested
- Bifihappy, Placebo
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifihappyDietary supplement
During the six weeks of treatment, the experimental group will take daily doses of 2,5 g with a concentration of 4x109 CFU/sachet of a mixture of lyophilised probiotic strains of the following species:
- Lactobacillus fermentum
- Lactobacillus rhamnosus
- Lactobacillus plantarum
- Bifidobacterium longum
PlaceboOther
During the six weeks of treatment, the experimental group will take daily doses of 2,5 g of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | the subjects are treated with probiotics: Bifihappy Receives: Dietary Supplement: Bifihappy |
| Group 2 | Placebo comparator | the subjects are treated with a placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the psychological profile
The primary outcome is the difference in the scores at the Leiden Index of Depression Sensitivity-Revised test (LEIDS-R) standardized questionnaire between the experimental and control groups. The Leiden Index of Depression Sensitivity-Revised test, LEIDS-R, is a self-report questionnaire that tests cognitive reactivity to sad mood, which is an index of cognitive vulnerability to depression.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Secondary outcomes (8)
Evaluation of mood - State Trait Anxiety Inventory (STAI) standardized questionnarie.
difference in the scores between the experimental and control groups. The State Trait Anxiety Inventory, STAI, is a self-report questionnaire that measures the presence and severity of current symptoms of anxiety and the propensity to be anxious.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of mood - Beck Depression Inventory (BDI-2) standardized questionnarie.
difference in the scores between the experimental and control groups. The Beck Depression Inventory, BDI-2, is a self-report questionnaire that measures the occurrence and severity of current depressive symptoms.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of mood - Profile od Mood State (POMS) standardized questionnarie.
difference in the scores between the experimental and control groups. The Profile of Mood State, POMS, is a self-report questionnaire that assesses mood.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of the quality of sleep.
difference in the scores between the experimental and control groups in the standardized questionnaire Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index, PSQI, is a self-report questionnaire that assesses sleep quality for the majority of days and nights in the past months.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Temperament and Character Inventory (TCI) standardized questionnarie.
difference in the scores between the experimental and control groups. The Temperament and Character Inventory, TCI, is a self-report, true-false questionnaire that measures two components of personality: temperament and character.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Cope Orientation to Problem Experienced-New Italian Version (COPE-NIV) standardized questionnarie.
difference in the scores between the experimental and control groups. The Cope Orientation to Problem Experienced - New Italian Version, COPE-NIV, is a self-report questionnaire that measures coping strategies: the cognitive and behavioral strategies people use to manage stressful situations.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS) standardized questionnarie.
difference in the scores between the experimental and control groups. The Behavioral Inhibition and Behavioral Activation Scale, BIS/BAS, is a self-report questionnaire that measures an individual's sensitivity to behavioral inhibition and behavioral activation systems.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Life Orientation Test-revisited (LOT-R) standardized questionnarie.
difference in the scores between the experimental and control groups. The Life Orientation Test-revisited, LOT-R, is a self-report measure of dispositional optimism and pessimism.
Measured: four evaluation sessions at intervals of three weeks of probiotic intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start20 Dec 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Model description
- The trial design is parallel, with two groups (experimental group and control group) and four evaluation sessions at intervals of three weeks (T0wk = baseline, T3wk = intermediate, T6wk=final and T9wk = follow-up).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probiotical S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universita di Verona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539263
- Sponsor's protocol ID
- 766CESC
- Status last verified
- May 2018
- First submitted
- 6 Apr 2018
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Publications
Barrett E, Ross RP, O'Toole PW, Fitzgerald GF, Stanton C. gamma-Aminobutyric acid production by culturable bacteria from the human intestine. J Appl Microbiol. 2012 Aug;113(2):411-7. doi: 10.1111/j.1365-2672.2012.05344.x. Epub 2012 Jun 15.
PubMed 22612585Beck A, Steer R, Brown G (1996). Manual for Beck Depression Inventory II (BDI-II). San Antonio, TX: Psychology Corporation
Block J, Kremen AM. IQ and ego-resiliency: conceptual and empirical connections and separateness. J Pers Soc Psychol. 1996 Feb;70(2):349-61. doi: 10.1037//0022-3514.70.2.349.
PubMed 8636887Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
PubMed 21876150Bravo JA, Julio-Pieper M, Forsythe P, Kunze W, Dinan TG, Bienenstock J, Cryan JF. Communication between gastrointestinal bacteria and the nervous system. Curr Opin Pharmacol. 2012 Dec;12(6):667-72. doi: 10.1016/j.coph.2012.09.010. Epub 2012 Oct 4.
PubMed 23041079Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Cloninger CR, Przybeck TR, Svrakic DM, Wetzel RD (1994). The Temperament and Character Inventory (TCI): A Guide to Its Development and Use (St. Louis, MO: Center for Psychobiology of Personality, Washington University).
Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.
PubMed 22968153Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
PubMed 22526760Davis MH (1980). A multidimensional approach to individual differences in empathy. JSAS Catalog of Selected Documents in Psychology, 10, 85
Desbonnet L, Garrett L, Clarke G, Bienenstock J, Dinan TG. The probiotic Bifidobacteria infantis: An assessment of potential antidepressant properties in the rat. J Psychiatr Res. 2008 Dec;43(2):164-74. doi: 10.1016/j.jpsychires.2008.03.009. Epub 2008 May 5.
PubMed 18456279Desbonnet L, Garrett L, Clarke G, Kiely B, Cryan JF, Dinan TG. Effects of the probiotic Bifidobacterium infantis in the maternal separation model of depression. Neuroscience. 2010 Nov 10;170(4):1179-88. doi: 10.1016/j.neuroscience.2010.08.005. Epub 2010 Aug 6.
PubMed 20696216Farma T & Cortinovis I (2001). Un questionario sul "Locus of Control": suo utilizzo nel contesto italiano. Ricerca in Psicoterapia, 1
Foster JA, McVey Neufeld KA. Gut-brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013 May;36(5):305-12. doi: 10.1016/j.tins.2013.01.005. Epub 2013 Feb 4.
PubMed 23384445Fraher MH, O'Toole PW, Quigley EM. Techniques used to characterize the gut microbiota: a guide for the clinician. Nat Rev Gastroenterol Hepatol. 2012 Mar 27;9(6):312-22. doi: 10.1038/nrgastro.2012.44.
PubMed 22450307
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Experimental Trial Designed to Test the Effects of Probiotics on Mood
- ClinicalTrials.gov ID
- NCT03539263
- Acronym / sponsor ID
- 766CESC
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Probiotical S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Universita di Verona
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 29 May 2018 (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.
Recent demonstration that probiotics administration has positive effects on depressive feelings in healthy populations suggests its possible role as an adjuvant therapy for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. The present study extends current knowledge on the beneficial effects of probiotics on psychological well-being, as measured by changes in mood (e.g., depression, anxiety, cognitive reactivity to sad mood), personality dimensions, and quality of sleep, which have been considered as related to mood. For this double-blind, placebo-controlled study healthy volunteers pseudo-randomly assigned to an experimental or control group assumed a daily dose of probiotic or placebo, respectively, for 6 weeks. Mood, personality dimensions, and sleep quality were assessed four times (before the beginning of the study, at 3 and 6 weeks, and at 3 weeks of washout).
Detailed description
- THEORETICAL BACKGROUND The intestine and the brain are intimately connected with each other through the gut-brain axis, which involves bidirectional communication between the nervous, endocrine and immune systems. In the last years, it has become increasingly evident that this communication implies also interactions with the intestinal bacterial flora, which releases immune activation and other signalling molecules that may play a major role in the regulation of the brain and human behaviour. For instance, the microbiota produces neuroactive substances and their precursors (e.g. tryptophan) that may reach the brain through the endocrine and autonomous nervous system. Recently, the interest has been focused also on the cognitive field. Indeed, there is experimental evidence that bacterial products may positively influence cognitive functions, such as spatial memory and problem-solving abilities. Moreover, probiotics seem to exercise influence on mood, anxiety and depression, opening new therapeutic prospects. A recent trial showed that four weeks of taking probiotics (Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 e W58) led to an improvement in mood, fostering reduction in negative thoughts.
- THE PURPOSE OF THE RESEARCH PROJECT The primary goal of the trial is to investigate the effect of probiotics on depression. Moreover, it will assess also effects on anxiety and other personality traits in healthy young students. The trial intends also to investigate whether probiotics may influence the quality of sleep and bowel habits. The trial will be placebo-controlled, randomized, pre- and post-intervention, double-blind designed (investigator and participants). In the light of the several end-points examined, the statistical analysis will be of explorative type.
The collection of faecal samples will allow, in case of finding any effects of the administered product on mood, to go back to any microbial components that have changed in individuals following the treatment. Monitoring (see below) the normal feed and physical habits of the individuals will allow to check the possible effect of these confounding factors on the parameters measured in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The trial design is parallel, with two groups (experimental group and control group) and four evaluation sessions at intervals of three weeks (T0wk = baseline, T3wk = intermediate, T6wk=final and T9wk = follow-up).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Bifihappythe subjects are treated with probiotics: Bifihappy |
| Group 2 | Placebo comparator | Other: Placebothe subjects are treated with a placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and Famale subjects.
- Aged between 18 and 35.
- Already owing a smartphone with Android or iOS system.
Key exclusion criteria (3 listed)
- Drug taking, smoking, coeliac disease, lactose intolerance.
- Disorders such as IBS (Irritable Bowel Syndrome), IBD (Irritable Bowel Disease), UC (Ulcerative Colitis) and other serious diseases, e.g. MS (Multiple Sclerosis) and diabetes (type 1/type 2).
- Oral intake of antibiotics and other medicines on a continuative basis.
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 |
|---|---|---|
| BifihappyDuring the six weeks of treatment, the experimental group will take daily doses of 2,5 g with a concentration of 4x109 CFU/sachet of a mixture of lyophilised probiotic strains of the following species: * Lactobacillus fermentum * Lactobacillus rhamnosus * Lactobacillus plantarum * Bifidobacterium longum | Dietary supplement | Group 1 |
| PlaceboDuring the six weeks of treatment, the experimental group will take daily doses of 2,5 g of maltodextrin | Other | Group 2 |
Primary outcome
Change in the psychological profile
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
The primary outcome is the difference in the scores at the Leiden Index of Depression Sensitivity-Revised test (LEIDS-R) standardized questionnaire between the experimental and control groups. The Leiden Index of Depression Sensitivity-Revised test, LEIDS-R, is a self-report questionnaire that tests cognitive reactivity to sad mood, which is an index of cognitive vulnerability to depression.
8 secondary outcomes
Evaluation of mood - State Trait Anxiety Inventory (STAI) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of mood - Beck Depression Inventory (BDI-2) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of mood - Profile od Mood State (POMS) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of the quality of sleep.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Temperament and Character Inventory (TCI) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Cope Orientation to Problem Experienced-New Italian Version (COPE-NIV) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
Evaluation of personality - Life Orientation Test-revisited (LOT-R) standardized questionnarie.
Time frame: four evaluation sessions at intervals of three weeks of probiotic intervention
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 29 May 2018.
- Background: PubMed 22612585Barrett E, Ross RP, O'Toole PW, Fitzgerald GF, Stanton C. gamma-Aminobutyric acid production by culturable bacteria from the human intestine. J Appl Microbiol. 2012 Aug;113(2):411-7. doi: 10.1111/j.1365-2672.2012.05344.x. Epub 2012 Jun 15.
- BackgroundBeck A, Steer R, Brown G (1996). Manual for Beck Depression Inventory II (BDI-II). San Antonio, TX: Psychology Corporation
- Background: PubMed 8636887Block J, Kremen AM. IQ and ego-resiliency: conceptual and empirical connections and separateness. J Pers Soc Psychol. 1996 Feb;70(2):349-61. doi: 10.1037//0022-3514.70.2.349.
- Background: PubMed 21876150Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
- Background: PubMed 23041079Bravo JA, Julio-Pieper M, Forsythe P, Kunze W, Dinan TG, Bienenstock J, Cryan JF. Communication between gastrointestinal bacteria and the nervous system. Curr Opin Pharmacol. 2012 Dec;12(6):667-72. doi: 10.1016/j.coph.2012.09.010. Epub 2012 Oct 4.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- BackgroundCloninger CR, Przybeck TR, Svrakic DM, Wetzel RD (1994). The Temperament and Character Inventory (TCI): A Guide to Its Development and Use (St. Louis, MO: Center for Psychobiology of Personality, Washington University).
- Background: PubMed 22968153Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.
- Background: PubMed 22526760Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
- BackgroundDavis MH (1980). A multidimensional approach to individual differences in empathy. JSAS Catalog of Selected Documents in Psychology, 10, 85
- Background: PubMed 18456279Desbonnet L, Garrett L, Clarke G, Bienenstock J, Dinan TG. The probiotic Bifidobacteria infantis: An assessment of potential antidepressant properties in the rat. J Psychiatr Res. 2008 Dec;43(2):164-74. doi: 10.1016/j.jpsychires.2008.03.009. Epub 2008 May 5.
- Background: PubMed 20696216Desbonnet L, Garrett L, Clarke G, Kiely B, Cryan JF, Dinan TG. Effects of the probiotic Bifidobacterium infantis in the maternal separation model of depression. Neuroscience. 2010 Nov 10;170(4):1179-88. doi: 10.1016/j.neuroscience.2010.08.005. Epub 2010 Aug 6.
- Individual participant dataSharing planned: Yes. Study Protocol
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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. 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 Bifihappy in people with Depression, Anxiety, run by Probiotical S.p.A. at 1 site in Italy.
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 3 inclusion and 3 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 29 May 2018. 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 Italy. 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?
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?
Change in the psychological profile (time frame: four evaluation sessions at intervals of three weeks of probiotic intervention). 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 NCT03539263, which also lists 45 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 29 May 2018.