DepressionPAMNCT05343533
Probiotic Administration on Mood
A study testing Probiotic in people with Depression and Sleep, run by Lindenwood University at 1 site in United States.
Trial summary
Researchers are looking to examine the impact of probiotic administration on symptoms commonly associated with depression, anxiety, stress, sleep quality, and associated emotional responses in healthy men and women. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Sleep, Stress
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 1 Jan 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18 - 50 years
- has a body mass index between 18.5 - 30 kg/m2.
- Anyone with a body mass index between 30 - 32 kg/m2, but has a body composition <25% fat -for men and <35% for women will be accepted into the study
- has been weight stable for the past three months (defined as less than a 5% variation in body -mass over this time)
- is determined to be healthy through completion of a health history questionnaire
Who cannot join
- Are currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, - renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
- are currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
- report having used anabolic steroids within the past 30 days
- report have used any illicit or recreational drugs within the past 30 days
- report the intake of any prescription or over-the-counter medications (i.e., antibiotics) that may impact study outcomes
- report the current use of any dietary supplements known to impact digestion or sleep quality for the past 30 days
Show all 9Show fewer
- report already taking a probiotic within the past 30 days
- have been actively trying to lose weight
- are currently following a ketogenic or low carbohydrate diet within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindenwood University
Saint Charles, Missouri, 63301
About this study
Official title: Impact of Probiotic Administration on Mood, Psychological Traits, Physical Activity, Stress, and Sleep Quality
Researchers are looking to examine the impact of probiotic administration on symptoms commonly associated with depression, anxiety, stress, sleep quality, and associated emotional responses in healthy men and women.
Read the detailed description
In recent years, the presence and awareness of a connection between the intestines and the brain has expanded leading to the understanding of developed communication pathways between the nervous, endocrine, and immune systems. Intestinal bacterial flora are active contributors to this axis through cellular signaling pathways and the release of immune system components, which fundamentally impact the function and action of various physiological systems. Interest in this area evolved through the understanding that various microbiota can produce neuroactive substances and neurotransmitters involved with the endocrine and autonomic nervous system pathways. This research has expanded to state that various bacterial products can influence cognitive functions, involving types of memory and problem-solving. Recent findings have begun to report on the impact that probiotic administration may have on mood, anxiety, and depression. Finally, recent work by Marotta et al. provided some of the first preliminary evidence that probiotic use may also impact mood and sleep quality. While initial work has developed this foundation, very little controlled research is available to help understand key contributing factors. For example, many key questions remain that future research should address to help better understand any impact probiotics may have on mood, depression, and anxiety. Some of these questions include:
Do all forms (genus, strain, etc.) of probiotics exert these impacts? How quickly do they exert impact? How large is the impact? Are certain aspect of affect more impacted than others? Once supplemented, how long is the residual impact (if there is any)? To help provided more guidance towards some of these basic research questions, this study is being proposed. The purpose of the study is to expand upon the previous work of Marotta et al. and determine the impact of probiotic administration on mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a larger group of healthy men and women. This study will expand on the supplementation regimen and include a wider variety of hormonal assessments than what has previously been completed using this combination of probiotics.
- Conditions
- Depression, Sleep, Stress, Anxiety, Mood Disorders
- Being tested
- Probiotic
- Medical subject headings
- Depression, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
After baseline or initial testing, participants will be randomly assigned in a double-blind fashion to ingest on a daily basis for 6 weeks either a placebo or a probiotic supplement. Identical follow-up measurements will then occur each visit after taking their assigned supplement. After 6 weeks of administration, the supplementation protocol will stop and a final evaluation will be completed 3 weeks later (9 weeks after initial administration) to assess any residual impact of the assigned supplement after a 3-week washout.
| Study group | Role | What they receive |
|---|---|---|
| Active Probiotic | Experimental | A mixture of probiotic strains (2.5 gram daily doses of 4 x 109 CFU/packet) of the following species (Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium longum). Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Maltodextrin capsule Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Index II
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Total Score Levels of Depression 0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression
Measured: 6 Weeks
COPE Inventory
The COPE Inventory is a multidimensional coping inventory to assess the different ways in which people respond to stress. Five scales (of four items each) measure conceptually distinct aspects of problem-focused coping (active coping, planning, suppression of competing activities, restraint coping, seeking of instrumental social support); five scales measure aspects of what might be viewed as emotion-focused coping (seeking of emotional social support, positive reinterpretation, acceptance, denial, turning to religion); and three scales measuring coping responses that arguably are less useful (focus on and venting of emotions, behavioral disengagement, mental disengagement).
Measured: 6 weeks
Leiden Index of Depression Sensitivity - Revised
The Leiden Index of Depression Sensitivity (LEIDS) measures cognitive reactivity (CR) to sadness, an aspect of cognitive vulnerability to depression, conceptually similar to rumination. A higher total score on all the subscales except acceptance and coping shows higher CR.
Measured: 6 weeks
Pittsburgh Sleep Quality Index
A self-rated questionnaire to assess sleep quality and disturbances
19 self-reported items Minimum score: 0; Maximum score: 21 Higher scoring indicated worse sleep quality
Measured: 6 weeks
State-Trait Anxiety Inventory form Y1 and Y2
Measure of trait and state anxiety. All items on the scale are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level.
Measured: 6 weeks
Behavioral Avoidance/Inhibition Scale
A measure of motivation to approach goal-oriented outcomes. Higher scores correspond to higher motivation to avoid goal oriented outcomes, lower scores indicate lower motivation to avoid goal-oriented outcomes.
Measured: 6 weeks
Bowel Health Questionnaire
Measure of bowel health. Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances
Measured: 6 weeks
Secondary outcomes (16)
Hours Asleep
Total hours asleep each night as obtained through a fit bit activity monitor
Measured: 6 weeks
Minutes Awake
Total minutes awake each night as obtained through a fit bit activity monitor
Measured: 6 weeks
Number of awakenings
Number of times awakened each night as obtained through a FitBit activity monitor
Measured: 6 weeks
Minutes of restlessness
Total minutes of restlessness each night as obtained through a FitBit activity monitor
Measured: 6 weeks
Number of times Restless
Number of times restless each night as obtained through a FitBit activity monitor
Measured: 6 weeks
Total time Awake and Restless
Total minutes of time awake and restless each night as obtained through a FitBit activity monitor
Measured: 6 weeks
Total time in Bed
Total time in bed each night as obtained through a FitBit activity monitor
Measured: 6 weeks
Calories Burned
Total KCal burned on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Steps
Total number of steps on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Distance
Total distance traveled each day on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Minutes Sedentary
Total minutes sedentary on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Minutes Lightly Active
Total minutes Lightly active on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Minutes Fairly Active
Total minutes Fairly active on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Minutes Very Active
Total minutes Very active on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Active Calories
Total minutes of active calories expended on average each day as obtained through a FitBit activity monitor
Measured: 6 weeks
Body Composition
DEXA derived fat mass and fat free mass and bodyfat percentage
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start17 Jul 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- andomized, double-blind, placebo-controlled, parallel study design that will evaluate the ability of a probiotic to influence mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a group of healthy men and women
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Collaborators
- Increnovo LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343533
- Sponsor's protocol ID
- IRB-19-212
- Acronym
- PAM
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kerksick CM, Moon JM, Walden KE, Hagele AM, Allen LE, Gaige CJ, Krieger JM, Jager R, Pane M, Mumford P. Multi-strain probiotic improves subjective sleep quality with no impact on body composition, hemodynamics, and physical activity. Benef Microbes. 2024 Jan 31;15(2):179-194. doi: 10.1163/18762891-bja00002.
PubMed 38350465Walden KE, Moon JM, Hagele AM, Allen LE, Gaige CJ, Krieger JM, Jager R, Mumford PW, Pane M, Kerksick CM. A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers. Front Nutr. 2023 Aug 31;10:1219313. doi: 10.3389/fnut.2023.1219313. eCollection 2023.
PubMed 37720373
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotic Administration on Mood, Psychological Traits, Physical Activity, Stress, and Sleep Quality
- ClinicalTrials.gov ID
- NCT05343533
- Acronym / sponsor ID
- PAM / IRB-19-212
- Conditions
- Depression, Sleep, Stress, Anxiety, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Collaborators
- Increnovo LLC
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Apr 2022 (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.
Researchers are looking to examine the impact of probiotic administration on symptoms commonly associated with depression, anxiety, stress, sleep quality, and associated emotional responses in healthy men and women.
Detailed description
In recent years, the presence and awareness of a connection between the intestines and the brain has expanded leading to the understanding of developed communication pathways between the nervous, endocrine, and immune systems. Intestinal bacterial flora are active contributors to this axis through cellular signaling pathways and the release of immune system components, which fundamentally impact the function and action of various physiological systems. Interest in this area evolved through the understanding that various microbiota can produce neuroactive substances and neurotransmitters involved with the endocrine and autonomic nervous system pathways. This research has expanded to state that various bacterial products can influence cognitive functions, involving types of memory and problem-solving. Recent findings have begun to report on the impact that probiotic administration may have on mood, anxiety, and depression. Finally, recent work by Marotta et al. provided some of the first preliminary evidence that probiotic use may also impact mood and sleep quality. While initial work has developed this foundation, very little controlled research is available to help understand key contributing factors. For example, many key questions remain that future research should address to help better understand any impact probiotics may have on mood, depression, and anxiety. Some of these questions include:
Do all forms (genus, strain, etc.) of probiotics exert these impacts? How quickly do they exert impact? How large is the impact? Are certain aspect of affect more impacted than others? Once supplemented, how long is the residual impact (if there is any)? To help provided more guidance towards some of these basic research questions, this study is being proposed. The purpose of the study is to expand upon the previous work of Marotta et al. and determine the impact of probiotic administration on mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a larger group of healthy men and women. This study will expand on the supplementation regimen and include a wider variety of hormonal assessments than what has previously been completed using this combination of probiotics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- andomized, double-blind, placebo-controlled, parallel study design that will evaluate the ability of a probiotic to influence mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a group of healthy men and women
| Arm | Type | Receives |
|---|---|---|
| Active Probiotic | Experimental | Dietary Supplement: ProbioticA mixture of probiotic strains (2.5 gram daily doses of 4 x 109 CFU/packet) of the following species (Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium longum). |
| Placebo | Placebo comparator | Dietary Supplement: ProbioticMaltodextrin capsule |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between the ages of 18 - 50 years
- has a body mass index between 18.5 - 30 kg/m2.
- Anyone with a body mass index between 30 - 32 kg/m2, but has a body composition <25% fat -for men and <35% for women will be accepted into the study
- has been weight stable for the past three months (defined as less than a 5% variation in body -mass over this time)
- is determined to be healthy through completion of a health history questionnaire
Key exclusion criteria (9 listed)
- Are currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, - renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
- are currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
- report having used anabolic steroids within the past 30 days
- report have used any illicit or recreational drugs within the past 30 days
- report the intake of any prescription or over-the-counter medications (i.e., antibiotics) that may impact study outcomes
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 |
|---|---|---|
| ProbioticAfter baseline or initial testing, participants will be randomly assigned in a double-blind fashion to ingest on a daily basis for 6 weeks either a placebo or a probiotic supplement. Identical follow-up measurements will then occur each visit after taking their assigned supplement. After 6 weeks of administration, the supplementation protocol will stop and a final evaluation will be completed 3 weeks later (9 weeks after initial administration) to assess any residual impact of the assigned supplement after a 3-week washout. | Dietary supplement | Active Probiotic, Placebo |
Primary outcome
Beck Depression Index II
Time frame: 6 Weeks
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Total Score Levels of Depression 0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression
COPE Inventory
Time frame: 6 weeks
The COPE Inventory is a multidimensional coping inventory to assess the different ways in which people respond to stress. Five scales (of four items each) measure conceptually distinct aspects of problem-focused coping (active coping, planning, suppression of competing activities, restraint coping, seeking of instrumental social support); five scales measure aspects of what might be viewed as emotion-focused coping (seeking of emotional social support, positive reinterpretation, acceptance, denial, turning to religion); and three scales measuring coping responses that arguably are less useful (focus on and venting of emotions, behavioral disengagement, mental disengagement).
Leiden Index of Depression Sensitivity - Revised
Time frame: 6 weeks
The Leiden Index of Depression Sensitivity (LEIDS) measures cognitive reactivity (CR) to sadness, an aspect of cognitive vulnerability to depression, conceptually similar to rumination. A higher total score on all the subscales except acceptance and coping shows higher CR.
Pittsburgh Sleep Quality Index
Time frame: 6 weeks
A self-rated questionnaire to assess sleep quality and disturbances 19 self-reported items Minimum score: 0; Maximum score: 21 Higher scoring indicated worse sleep quality
State-Trait Anxiety Inventory form Y1 and Y2
Time frame: 6 weeks
Measure of trait and state anxiety. All items on the scale are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level.
Behavioral Avoidance/Inhibition Scale
Time frame: 6 weeks
A measure of motivation to approach goal-oriented outcomes. Higher scores correspond to higher motivation to avoid goal oriented outcomes, lower scores indicate lower motivation to avoid goal-oriented outcomes.
Bowel Health Questionnaire
Time frame: 6 weeks
Measure of bowel health. Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances
16 secondary outcomes
Hours Asleep
Time frame: 6 weeks
Minutes Awake
Time frame: 6 weeks
Number of awakenings
Time frame: 6 weeks
Minutes of restlessness
Time frame: 6 weeks
Number of times Restless
Time frame: 6 weeks
Total time Awake and Restless
Time frame: 6 weeks
Total time in Bed
Time frame: 6 weeks
Calories Burned
Time frame: 6 weeks
Steps
Time frame: 6 weeks
Distance
Time frame: 6 weeks
Minutes Sedentary
Time frame: 6 weeks
Minutes Lightly Active
Time frame: 6 weeks
Minutes Fairly Active
Time frame: 6 weeks
Minutes Very Active
Time frame: 6 weeks
Active Calories
Time frame: 6 weeks
Body Composition
Time frame: 6 weeks
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 25 Apr 2022.
- Derived from this study: PubMed 38350465Kerksick CM, Moon JM, Walden KE, Hagele AM, Allen LE, Gaige CJ, Krieger JM, Jager R, Pane M, Mumford P. Multi-strain probiotic improves subjective sleep quality with no impact on body composition, hemodynamics, and physical activity. Benef Microbes. 2024 Jan 31;15(2):179-194. doi: 10.1163/18762891-bja00002.
- Derived from this study: PubMed 37720373Walden KE, Moon JM, Hagele AM, Allen LE, Gaige CJ, Krieger JM, Jager R, Mumford PW, Pane M, Kerksick CM. A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers. Front Nutr. 2023 Aug 31;10:1219313. doi: 10.3389/fnut.2023.1219313. eCollection 2023.
- Individual participant dataSharing planned: No
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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 Probiotic in people with Depression and Sleep, run by Lindenwood University at 1 site in United States.
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 5 inclusion and 9 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 25 Apr 2022. 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 United States. 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?
Beck Depression Index II (time frame: 6 Weeks). The study lists 7 primary outcomes in all. 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 NCT05343533, which also lists 2 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 25 Apr 2022.