Depression Anxiety DisorderPhase 2/3NCT06765057
Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia
A Phase 2/3 study testing Winclove's Ecologic® Barrier Probiotics in people with Depression Anxiety Disorder, run by Roaa Ahmed Alkreadees at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Anxiety Disorder
- What is being tested?
- Winclove's Ecologic® Barrier Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Mar 2025to 30 Jan 2027
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depression Disorder (MDD) patients on antidepressants for at least 4 weeks or more.
- MDD patients with pre-metabolic syndrome (at least 2 of the MetS components) and metabolic syndrome (at least 3 of the following components: central obesity with WC for men ≥ 94 centimeters while for women ≥ 80 centimeter, increased FPG ≥ 100 mg/dl, increased BP to ≥ 130 / ≥ 85 mmHg, increased TGs equal or above 150 mg / dl, increased HDL cholesterol for men to < 40 mg / dl while for women < 50 mg / dl) (IDF., 2006).
- MDD patients with other comorbid diseases such as anxiety.
Who cannot join
- Patients using any other supplements to improve mood.
- Patients using pre/pro/symbiotics supplement or antibiotics during the last 3 weeks before the intervention.
- Patients with chronic diseases (cardiac, renal, or hepatic diseases)
- Patients with gastro intestinal diseases (Crohn's disease, ulcerative colitis).
- Patients with infectious diseases (HIV/AIDS).
- Cancer patients or those undergoing chemotherapy.
Show all 15Show fewer
- Patients with food allergies such as gluten intolerance or lactose intolerance.
- Pregnant and breastfeeding women.
- Patients with modified antidepressant dose during interventional period or receiving psychotherapy during the intervention.
- Patients with thyroid disorder.
- Patients following a diet to lose weight during the intervention.
- Diabetic patients who are insulin-dependent.
- patients receiving injections or medications to lose weight (Ozempic, Mounjaro …etc) either 3 weeks before or during the intervention.
- Patients using plasma-lipid lowering drug for less than 1 month before the intervention.
- Patients with substance abuse including alcohol addiction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud University Medical City
Riyadh, Riyadh Region
Roaa A. Alkreadees, MS, 966555527073, 442203635@student.ksu.edu.sa
About this study
Official title: Effect of Probiotics "Psychobiotics" on Depression in Adults With Pre-Metabolic Syndrome and Metabolic Syndrome in Riyadh City
The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The second goal is to explore the effect of commercial multi-strains psychobiotics supplementation on the anthropometric measurement (weight, body mass index (BMI)) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The main questions they aim to answer are:
- Will commercial multi-strains psychobiotics supplementation help to ease depressive symptoms as an ad-on therapy in patients with pre-metabolic syndrome and metabolic syndrome?
- Will commercial multi-strains psychobiotics supplementation improve anthropometric measurements and metabolic syndrome components (WC, FPG, BP, TGs, HDL-C) in depressed patients? Researchers will compare psychobiotics to a placebo (a look-alike substance that contains no drug) to see if psychobiotics work to improve depression and metabolic syndrome components.
Read more
Participants will:
- Be examined for depression, anxiety, and metabolic syndrome components (waist circumference, diabetes, blood pressure, triglycerides, and high-density lipoprotein).
- Be asked to conduct laboratory tests to determine the inclusion and exclusion criteria.
- Be given probiotics/ placebo to consume every day for 3 months (12 weeks).
- Repeat the examination and laboratory tests to determine the results.
- Be followed up weekly for adverse events and to insure their compliance with the study instructions.
- Be followed up after 4 weeks as an end-visit and will conduct the examination and the laboratory blood tests.
Read the detailed description
Recently, the United Nations (UN) announced depression as the leading cause of disability worldwide. According to the World Health Organization (WHO), depression can increase the risk of suicide and death. Its prevalence increased globally since 2005 from 4.4% and reached 18.4% in 2015 accounting for about 322 million of the population. Based on the study of the Global Burden of Disease (GBD) from 195 countries around the world including Saudi Arabia, depression incidence increased from 172.27 million to 258.16 million from 1990 to 2017 most of whom is from major depressive disorder (MDD).
In addition, according to the Saudi National Mental Health Survey in 2016, 34% of Saudis were having psychiatric disorders and 80% of those with severe situations did not attempt any health care. Moreover, the prevalence of MDD among Saudis was 0.6% and it was one of the top-rated mental health cases in Saudi Arabia. Not only that but also, a cross-sectional study showed that the incidence of depression increased even more among Saudis during the pandemic of coronavirus disease-19 (COVID-19) to be 20.9%.
Depression is characterized by a persistent feeling of sadness, loss of interest, feeling of low self-esteem, loss of energy, decreased or increased appetite, trouble sleeping, and thoughts of suicide. Basically, depression is categorized into two main categories which are MDD and persistent depressive disorder (known as dysthymia). Depression can impair the quality of life and well-being. Unfortunately, it can also affect health negatively by causing comorbid diseases such as cancer, heart disease, inflammation, and neurological and metabolic disorders.
According to Al-Khatib et al (2022), one of the metabolic disorders associated with depression is metabolic syndrome (MetS). The International Diabetes Federation (IDF) defined the MetS as the occurrence of three or more symptoms of the following: central obesity with waist circumference (WC) for men ≥ 94 centimeters while for women ≥ 80 centimeters, increased fasting plasma glucose (FPG) ≥ 100 mg/dl, increased blood pressure (BP) to ≥ 130 /≥ 85 mmHg, increased triglycerides (TGs) to equal or above 150 mg/dl, reduced high-density lipoprotein cholesterol (HDL-C) for men to < 40 mg/dl while for women < 50 mg/dl. Yin et al., 2013 defined the pre-metabolic syndrome (Pre-MetS) as the occurrence of at least two components of MetS that do not reach the diagnostic of MetS. As a matter of fact, depression can lead to MetS and vice versa. About 30% of individuals with depression have MetS; meanwhile, about 41% of individuals with depression and MetS also have high levels of inflammation. Individuals with inflammation tend to have obesity and MetS. Thus, in 2007, it was proposed that the onset of depression with comorbid MetS is called "MetS type II" in which a combination of neuronal, psychological, and metabolic disorder happens. Furthermore, Gawlik-Kotelnicka and Strzelecki mentioned in their recent review the term "metabolic depression" to depict the relationship between depression, obesity, and MetS.
Recently, it has been suggested that gut microbiota modulation by a combination of probiotics and anti-depressant is an effective treatment. Since the bidirectional relationship between brain and gut health was confirmed, the accumulated body of evidence revealed that mental health is impacted by what is called the gut-brain axis (GBA) in which the gut microbiome can affect brain health through special microorganisms known as psychobiotics. Psychobiotics are special types of probiotics; they are specified to positively influence neurotransmitters, endocrinal hormones, and anti-inflammatory cytokines. They are a supporting therapy as an add-on therapy for mood disorders and depression with little or no side effects. To our knowledge, there are no clinical trials conducting in Saudi Arabia to investigate the impact of probiotics efficiency on depressive symptoms, anthropometric measurement, and MetS components in adult patients which is the aim of this experimental study.
- Conditions
- Depression Anxiety Disorder
- Being tested
- Winclove's Ecologic® Barrier Probiotics, Winclove's Ecologic® Barrier Probiotics Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winclove's Ecologic® Barrier ProbioticsDietary supplement
The investigational product is a multispecies probiotic formulation consisting of 9 selected probiotic strains: the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58.
Winclove's Ecologic® Barrier Probiotics PlaceboDietary supplement
The placebo is composed of the carrier of the probiotic product that are identical in physical appearance, it includes maize starch and maltodextrins but contains no bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Winclove's Ecologic® Barrier Probiotics | Experimental | Patients in the interventional group will consume psychobiotics daily in addition to their antidepressant medication for 12 weeks. All patients will be instructed to take 1 sachet in the morning before breakfast, and 1 sachet at the end of the day before going to bed. The product is a multispecies probiotic formulation consisting of 9 selected probiotic strains by Winclove's Ecologic® Barrier, Amsterdam, The Netherlands. Each participant will receive 6 boxes of the probiotic supplement, each box contains 30 sachets of 3 grams (180 sachets in total). During the period of 12 weeks, each participant will consume 168 sachets. The probiotic supplement is a freeze-dried powder of probiotic mixture at a dose of 2,5 x 109 colony forming units (CFU) per gram. Since participants should consume 2 sachets/day, they will consume 6 grams in total which equals 1.5 × 10^10 CFU. Receives: Dietary Supplement: Winclove's Ecologic® Barrier Probiotics |
| Control | Placebo comparator | Patients in the control group will consume similar sachets that are identical in physical appearance. The placebo is composed of the carrier of the probiotic product, that is maize starch and maltodextrins but contains no bacteria. Receives: Dietary Supplement: Winclove's Ecologic® Barrier Probiotics Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Assessment (depression1)
- Depression will be diagnosed clinically using the validated Arabic translated Patient Health Questionary 9 (PHQ-9) in Saudi population to assess the severity of depression as a self-report scale for patients in both groups. The minimum score is 0 while the maximum score is 27; the higher the score the more severe the depression is. Scores 0-4 means no depression; scores 5-9 means mild depression; scores 10-14 means moderate depression; score 15-19 means moderately severe, and 20-27 means severe depression.
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Psychological Assessment (depression2)
- Hamilton Depression Rating Scale (HDRS) will be also used as a clinician-rated scale to evaluate the severity of depression symptoms. The most commonly used versions in are either a 17- or a 21-item scale, but this study uses the 21-item scale. The scoring of the severity of the depressive symptoms is based on 17 items. It is scored between 0 (not present) and 4 (severe) points using either a three-point or a five-point scale and summed up to obtain the total score. Scores 0-7 represent the absence or remission of depression; scores between 8-16 represent mild depression; scores between 17-23 represent moderate depression, and scores equal to 24 and above represent severe depression.
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Psychological Assessment (Anxiety)
- Generalized Anxiety Disorder-7 (GAD-7) scale will be added to assess anxiety. Each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21; the higher the score the more severe the anxiety is. Scores 0-4 means no anxiety; scores 5-9 means mild anxiety; scores 10-14 means moderate anxiety; score 15-21 means severe anxiety.
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Anthropometric Measurements
Height and weight will be combined to calculate the body mass index (BMI). BMI will be measured through dividing individual's weight in kilograms by height in square meter. Lower than 18.5 means underweight; 18.5 to lower than or equal 25 means normal weight; 25.0 to lower than or equal 30 means overweight; 30.0 or above means obese (Centers for Disease Control and Prevention (CDC), 2020).
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Metabolic Syndrome Components (Waist circumference)
Central obesity will be measured through waist circumference (WC) by placing non-stretchable meter around the waist above the bone of the hip equally; the tape should be tightened lightly without pressure on skin (Whitney \& Rolfes, 2020). WC for men is ≥ 94 centimeters while for women ≥ 80 centimeters (Alberti, Zimmet, \& Shaw, 2006).
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Metabolic Syndrome Components (Medical Assessments/ Laboratory Tests)
Blood samples will be collected out on venous blood after fasting for 12 h. Blood samples in each visit will be collected in 3 tubes and the value will be 3 ml in each tube.
- Fasting Plasma Glucose: pre-diabetic is more than 100 mg/dl to 125 mg/dl (Alberti, Zimmet, \& Shaw, 2006). ii. Hemoglobin A1C (HgA1C): pre-diabetic HbA1c is between 5.7 - 6.5% (Alberti, Zimmet, \& Shaw, 2006). iii. Triglycerides: more than 150 mg/dl (Alberti, Zimmet, \& Shaw, 2006). iv. High Density Lipoprotein-Cholesterol: less than 40 mg/dl in men and less than 50 mg/dl in women (Alberti, Zimmet, \& Shaw, 2006).
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Metabolic Syndrome Components (Medical Assessments/ Blood Pressure)
- Blood pressure for both groups will be measured three times sequentially at 1-min interval using the standardized method, the average between the three readings will be used as study variable (if more than 130 mmHg systolic BP/or more than 85 mmHg diastolic BP).
Measured: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start2 Mar 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Depression Anxiety DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roaa Ahmed Alkreadees
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Roaa Ahmed Alkreadees, King Saud Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765057
- Sponsor's protocol ID
- E-23-7867
- Status last verified
- Sep 2025
- First submitted
- 24 Dec 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with the probiotics company (Winclove's). KSUMC will provide Winclove with "raw data" a complete overview of the final results of the study after analysis and after anonymization to comply with applicable regulations, but not with patient identifying data.
Publications
Altwaijri YA, Al-Habeeb A, Al-Subaie AS, Bilal L, Al-Desouki M, Shahab MK, Hyder S, Sampson NA, King AJ, Kessler RC. Twelve-month prevalence and severity of mental disorders in the Saudi National Mental Health Survey. Int J Methods Psychiatr Res. 2020 Sep;29(3):e1831. doi: 10.1002/mpr.1831. Epub 2020 Aug 15.
PubMed 33245602Al-Khatib Y, Akhtar MA, Kanawati MA, Mucheke R, Mahfouz M, Al-Nufoury M. Depression and Metabolic Syndrome: A Narrative Review. Cureus. 2022 Feb 12;14(2):e22153. doi: 10.7759/cureus.22153. eCollection 2022 Feb.
PubMed 35308733AlHadi AN, Alarabi MA, AlMansoor KM. Mental health and its association with coping strategies and intolerance of uncertainty during the COVID-19 pandemic among the general population in Saudi Arabia: cross-sectional study. BMC Psychiatry. 2021 Jul 28;21(1):382. doi: 10.1186/s12888-021-03370-4.
PubMed 34320930Gawlik-Kotelnicka O, Strzelecki D. Probiotics as a Treatment for "Metabolic Depression"? A Rationale for Future Studies. Pharmaceuticals (Basel). 2021 Apr 20;14(4):384. doi: 10.3390/ph14040384.
PubMed 33924064Gold SM, Kohler-Forsberg O, Moss-Morris R, Mehnert A, Miranda JJ, Bullinger M, Steptoe A, Whooley MA, Otte C. Comorbid depression in medical diseases. Nat Rev Dis Primers. 2020 Aug 20;6(1):69. doi: 10.1038/s41572-020-0200-2.
PubMed 32820163Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006 May;23(5):469-80. doi: 10.1111/j.1464-5491.2006.01858.x.
PubMed 16681555Liu Q, He H, Yang J, Feng X, Zhao F, Lyu J. Changes in the global burden of depression from 1990 to 2017: Findings from the Global Burden of Disease study. J Psychiatr Res. 2020 Jul;126:134-140. doi: 10.1016/j.jpsychires.2019.08.002. Epub 2019 Aug 10.
PubMed 31439359Park C, Brietzke E, Rosenblat JD, Musial N, Zuckerman H, Ragguett RM, Pan Z, Rong C, Fus D, McIntyre RS. Probiotics for the treatment of depressive symptoms: An anti-inflammatory mechanism? Brain Behav Immun. 2018 Oct;73:115-124. doi: 10.1016/j.bbi.2018.07.006. Epub 2018 Jul 18.
PubMed 30009996Sharma R, Gupta D, Mehrotra R, Mago P. Psychobiotics: The Next-Generation Probiotics for the Brain. Curr Microbiol. 2021 Feb;78(2):449-463. doi: 10.1007/s00284-020-02289-5. Epub 2021 Jan 4.
PubMed 33394083Vlainic JV, Suran J, Vlainic T, Vukorep AL. Probiotics as an Adjuvant Therapy in Major Depressive Disorder. Curr Neuropharmacol. 2016;14(8):952-958. doi: 10.2174/1570159x14666160526120928.
PubMed 27226112
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics "Psychobiotics" on Depression in Adults With Pre-Metabolic Syndrome and Metabolic Syndrome in Riyadh City
- ClinicalTrials.gov ID
- NCT06765057
- Acronym / sponsor ID
- E-23-7867
- Conditions
- Depression Anxiety Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Roaa Ahmed AlkreadeesOther government
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The second goal is to explore the effect of commercial multi-strains psychobiotics supplementation on the anthropometric measurement (weight, body mass index (BMI)) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The main questions they aim to answer are:
- Will commercial multi-strains psychobiotics supplementation help to ease depressive symptoms as an ad-on therapy in patients with pre-metabolic syndrome and metabolic syndrome?
- Will commercial multi-strains psychobiotics supplementation improve anthropometric measurements and metabolic syndrome components (WC, FPG, BP, TGs, HDL-C) in depressed patients? Researchers will compare psychobiotics to a placebo (a look-alike substance that contains no drug) to see if psychobiotics work to improve depression and metabolic syndrome components.
Participants will:
- Be examined for depression, anxiety, and metabolic syndrome components (waist circumference, diabetes, blood pressure, triglycerides, and high-density lipoprotein).
- Be asked to conduct laboratory tests to determine the inclusion and exclusion criteria.
- Be given probiotics/ placebo to consume every day for 3 months (12 weeks).
- Repeat the examination and laboratory tests to determine the results.
- Be followed up weekly for adverse events and to insure their compliance with the study instructions.
- Be followed up after 4 weeks as an end-visit and will conduct the examination and the laboratory blood tests.
Detailed description
Recently, the United Nations (UN) announced depression as the leading cause of disability worldwide. According to the World Health Organization (WHO), depression can increase the risk of suicide and death. Its prevalence increased globally since 2005 from 4.4% and reached 18.4% in 2015 accounting for about 322 million of the population. Based on the study of the Global Burden of Disease (GBD) from 195 countries around the world including Saudi Arabia, depression incidence increased from 172.27 million to 258.16 million from 1990 to 2017 most of whom is from major depressive disorder (MDD).
In addition, according to the Saudi National Mental Health Survey in 2016, 34% of Saudis were having psychiatric disorders and 80% of those with severe situations did not attempt any health care. Moreover, the prevalence of MDD among Saudis was 0.6% and it was one of the top-rated mental health cases in Saudi Arabia. Not only that but also, a cross-sectional study showed that the incidence of depression increased even more among Saudis during the pandemic of coronavirus disease-19 (COVID-19) to be 20.9%.
Depression is characterized by a persistent feeling of sadness, loss of interest, feeling of low self-esteem, loss of energy, decreased or increased appetite, trouble sleeping, and thoughts of suicide. Basically, depression is categorized into two main categories which are MDD and persistent depressive disorder (known as dysthymia). Depression can impair the quality of life and well-being. Unfortunately, it can also affect health negatively by causing comorbid diseases such as cancer, heart disease, inflammation, and neurological and metabolic disorders.
According to Al-Khatib et al (2022), one of the metabolic disorders associated with depression is metabolic syndrome (MetS). The International Diabetes Federation (IDF) defined the MetS as the occurrence of three or more symptoms of the following: central obesity with waist circumference (WC) for men ≥ 94 centimeters while for women ≥ 80 centimeters, increased fasting plasma glucose (FPG) ≥ 100 mg/dl, increased blood pressure (BP) to ≥ 130 /≥ 85 mmHg, increased triglycerides (TGs) to equal or above 150 mg/dl, reduced high-density lipoprotein cholesterol (HDL-C) for men to < 40 mg/dl while for women < 50 mg/dl. Yin et al., 2013 defined the pre-metabolic syndrome (Pre-MetS) as the occurrence of at least two components of MetS that do not reach the diagnostic of MetS. As a matter of fact, depression can lead to MetS and vice versa. About 30% of individuals with depression have MetS; meanwhile, about 41% of individuals with depression and MetS also have high levels of inflammation. Individuals with inflammation tend to have obesity and MetS. Thus, in 2007, it was proposed that the onset of depression with comorbid MetS is called "MetS type II" in which a combination of neuronal, psychological, and metabolic disorder happens. Furthermore, Gawlik-Kotelnicka and Strzelecki mentioned in their recent review the term "metabolic depression" to depict the relationship between depression, obesity, and MetS.
Recently, it has been suggested that gut microbiota modulation by a combination of probiotics and anti-depressant is an effective treatment. Since the bidirectional relationship between brain and gut health was confirmed, the accumulated body of evidence revealed that mental health is impacted by what is called the gut-brain axis (GBA) in which the gut microbiome can affect brain health through special microorganisms known as psychobiotics. Psychobiotics are special types of probiotics; they are specified to positively influence neurotransmitters, endocrinal hormones, and anti-inflammatory cytokines. They are a supporting therapy as an add-on therapy for mood disorders and depression with little or no side effects. To our knowledge, there are no clinical trials conducting in Saudi Arabia to investigate the impact of probiotics efficiency on depressive symptoms, anthropometric measurement, and MetS components in adult patients which is the aim of this experimental study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Winclove's Ecologic® Barrier Probiotics | Experimental | Dietary Supplement: Winclove's Ecologic® Barrier ProbioticsPatients in the interventional group will consume psychobiotics daily in addition to their antidepressant medication for 12 weeks. All patients will be instructed to take 1 sachet in the morning before breakfast, and 1 sachet at the end of the day before going to bed. The product is a multispecies probiotic formulation consisting of 9 selected probiotic strains by Winclove's Ecologic® Barrier, Amsterdam, The Netherlands. Each participant will receive 6 boxes of the probiotic supplement, each box contains 30 sachets of 3 grams (180 sachets in total). During the period of 12 weeks, each participant will consume 168 sachets. The probiotic supplement is a freeze-dried powder of probiotic mixture at a dose of 2,5 x 109 colony forming units (CFU) per gram. Since participants should consume 2 sachets/day, they will consume 6 grams in total which equals 1.5 × 10^10 CFU. |
| Control | Placebo comparator | Dietary Supplement: Winclove's Ecologic® Barrier Probiotics PlaceboPatients in the control group will consume similar sachets that are identical in physical appearance. The placebo is composed of the carrier of the probiotic product, that is maize starch and maltodextrins but contains no bacteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major Depression Disorder (MDD) patients on antidepressants for at least 4 weeks or more.
- MDD patients with pre-metabolic syndrome (at least 2 of the MetS components) and metabolic syndrome (at least 3 of the following components: central obesity with WC for men ≥ 94 centimeters while for women ≥ 80 centimeter, increased FPG ≥ 100 mg/dl, increased BP to ≥ 130 / ≥ 85 mmHg, increased TGs equal or above 150 mg / dl, increased HDL cholesterol for men to < 40 mg / dl while for women < 50 mg / dl) (IDF., 2006).
- MDD patients with other comorbid diseases such as anxiety.
Key exclusion criteria (15 listed)
- Patients using any other supplements to improve mood.
- Patients using pre/pro/symbiotics supplement or antibiotics during the last 3 weeks before the intervention.
- Patients with chronic diseases (cardiac, renal, or hepatic diseases)
- Patients with gastro intestinal diseases (Crohn's disease, ulcerative colitis).
- Patients with infectious diseases (HIV/AIDS).
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 |
|---|---|---|
| Winclove's Ecologic® Barrier ProbioticsThe investigational product is a multispecies probiotic formulation consisting of 9 selected probiotic strains: the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58. | Dietary supplement | Winclove's Ecologic® Barrier Probiotics |
| Winclove's Ecologic® Barrier Probiotics PlaceboThe placebo is composed of the carrier of the probiotic product that are identical in physical appearance, it includes maize starch and maltodextrins but contains no bacteria. | Dietary supplement | Control |
Primary outcome
Psychological Assessment (depression1)
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
• Depression will be diagnosed clinically using the validated Arabic translated Patient Health Questionary 9 (PHQ-9) in Saudi population to assess the severity of depression as a self-report scale for patients in both groups. The minimum score is 0 while the maximum score is 27; the higher the score the more severe the depression is. Scores 0-4 means no depression; scores 5-9 means mild depression; scores 10-14 means moderate depression; score 15-19 means moderately severe, and 20-27 means severe depression.
Psychological Assessment (depression2)
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
• Hamilton Depression Rating Scale (HDRS) will be also used as a clinician-rated scale to evaluate the severity of depression symptoms. The most commonly used versions in are either a 17- or a 21-item scale, but this study uses the 21-item scale. The scoring of the severity of the depressive symptoms is based on 17 items. It is scored between 0 (not present) and 4 (severe) points using either a three-point or a five-point scale and summed up to obtain the total score. Scores 0-7 represent the absence or remission of depression; scores between 8-16 represent mild depression; scores between 17-23 represent moderate depression, and scores equal to 24 and above represent severe depression.
Psychological Assessment (Anxiety)
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
• Generalized Anxiety Disorder-7 (GAD-7) scale will be added to assess anxiety. Each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21; the higher the score the more severe the anxiety is. Scores 0-4 means no anxiety; scores 5-9 means mild anxiety; scores 10-14 means moderate anxiety; score 15-21 means severe anxiety.
Anthropometric Measurements
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Height and weight will be combined to calculate the body mass index (BMI). BMI will be measured through dividing individual's weight in kilograms by height in square meter. Lower than 18.5 means underweight; 18.5 to lower than or equal 25 means normal weight; 25.0 to lower than or equal 30 means overweight; 30.0 or above means obese (Centers for Disease Control and Prevention (CDC), 2020).
Metabolic Syndrome Components (Waist circumference)
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Central obesity will be measured through waist circumference (WC) by placing non-stretchable meter around the waist above the bone of the hip equally; the tape should be tightened lightly without pressure on skin (Whitney \& Rolfes, 2020). WC for men is ≥ 94 centimeters while for women ≥ 80 centimeters (Alberti, Zimmet, \& Shaw, 2006).
Metabolic Syndrome Components (Medical Assessments/ Laboratory Tests)
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
Blood samples will be collected out on venous blood after fasting for 12 h. Blood samples in each visit will be collected in 3 tubes and the value will be 3 ml in each tube. i. Fasting Plasma Glucose: pre-diabetic is more than 100 mg/dl to 125 mg/dl (Alberti, Zimmet, \& Shaw, 2006). ii. Hemoglobin A1C (HgA1C): pre-diabetic HbA1c is between 5.7 - 6.5% (Alberti, Zimmet, \& Shaw, 2006). iii. Triglycerides: more than 150 mg/dl (Alberti, Zimmet, \& Shaw, 2006). iv. High Density Lipoprotein-Cholesterol: less than 40 mg/dl in men and less than 50 mg/dl in women (Alberti, Zimmet, \& Shaw, 2006).
Metabolic Syndrome Components (Medical Assessments/ Blood Pressure)
Time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).
• Blood pressure for both groups will be measured three times sequentially at 1-min interval using the standardized method, the average between the three readings will be used as study variable (if more than 130 mmHg systolic BP/or more than 85 mmHg diastolic BP).
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 22 Sep 2025.
- Background: PubMed 33245602Altwaijri YA, Al-Habeeb A, Al-Subaie AS, Bilal L, Al-Desouki M, Shahab MK, Hyder S, Sampson NA, King AJ, Kessler RC. Twelve-month prevalence and severity of mental disorders in the Saudi National Mental Health Survey. Int J Methods Psychiatr Res. 2020 Sep;29(3):e1831. doi: 10.1002/mpr.1831. Epub 2020 Aug 15.
- Background: PubMed 35308733Al-Khatib Y, Akhtar MA, Kanawati MA, Mucheke R, Mahfouz M, Al-Nufoury M. Depression and Metabolic Syndrome: A Narrative Review. Cureus. 2022 Feb 12;14(2):e22153. doi: 10.7759/cureus.22153. eCollection 2022 Feb.
- Background: PubMed 34320930AlHadi AN, Alarabi MA, AlMansoor KM. Mental health and its association with coping strategies and intolerance of uncertainty during the COVID-19 pandemic among the general population in Saudi Arabia: cross-sectional study. BMC Psychiatry. 2021 Jul 28;21(1):382. doi: 10.1186/s12888-021-03370-4.
- Background: PubMed 33924064Gawlik-Kotelnicka O, Strzelecki D. Probiotics as a Treatment for "Metabolic Depression"? A Rationale for Future Studies. Pharmaceuticals (Basel). 2021 Apr 20;14(4):384. doi: 10.3390/ph14040384.
- Background: PubMed 32820163Gold SM, Kohler-Forsberg O, Moss-Morris R, Mehnert A, Miranda JJ, Bullinger M, Steptoe A, Whooley MA, Otte C. Comorbid depression in medical diseases. Nat Rev Dis Primers. 2020 Aug 20;6(1):69. doi: 10.1038/s41572-020-0200-2.
- Background: PubMed 16681555Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006 May;23(5):469-80. doi: 10.1111/j.1464-5491.2006.01858.x.
- Background: PubMed 31439359Liu Q, He H, Yang J, Feng X, Zhao F, Lyu J. Changes in the global burden of depression from 1990 to 2017: Findings from the Global Burden of Disease study. J Psychiatr Res. 2020 Jul;126:134-140. doi: 10.1016/j.jpsychires.2019.08.002. Epub 2019 Aug 10.
- Background: PubMed 30009996Park C, Brietzke E, Rosenblat JD, Musial N, Zuckerman H, Ragguett RM, Pan Z, Rong C, Fus D, McIntyre RS. Probiotics for the treatment of depressive symptoms: An anti-inflammatory mechanism? Brain Behav Immun. 2018 Oct;73:115-124. doi: 10.1016/j.bbi.2018.07.006. Epub 2018 Jul 18.
- Background: PubMed 33394083Sharma R, Gupta D, Mehrotra R, Mago P. Psychobiotics: The Next-Generation Probiotics for the Brain. Curr Microbiol. 2021 Feb;78(2):449-463. doi: 10.1007/s00284-020-02289-5. Epub 2021 Jan 4.
- Background: PubMed 27226112Vlainic JV, Suran J, Vlainic T, Vukorep AL. Probiotics as an Adjuvant Therapy in Major Depressive Disorder. Curr Neuropharmacol. 2016;14(8):952-958. doi: 10.2174/1570159x14666160526120928.
- Major Depressive DisorderLink provided by the sponsor.
- UN health agency reports depression now 'leading cause of disability worldwide'Link provided by the sponsor.
- Depression and Other Common Mental Disorders: Global Health EstimatesLink provided by the sponsor.
- Apolipoprotein B/apolipoprotein A1 ratio is a good predictive marker of metabolic syndrome and pre-metabolic syndrome in Chinese adolescent women with polycystic ovary syndromeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared with the probiotics company (Winclove's). KSUMC will provide Winclove with "raw data" a complete overview of the final results of the study after analysis and after anonymization to comply with applicable regulations, but not with patient identifying data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Winclove's Ecologic® Barrier Probiotics in people with Depression Anxiety Disorder, run by Roaa Ahmed Alkreadees at 1 site in Saudi Arabia.
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 15 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 22 Sep 2025. 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 Saudi Arabia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Roaa A Alkreadees (00966555527073, 442203635@student.ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Assessment (depression1) (time frame: at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).). 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 NCT06765057, which also lists 10 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 22 Sep 2025.