Major DepressionNCT07691749
Effect of Psychobiotics With Standard Antiddepressants in Treatment of Major Depressive Disorder
A study testing Lactobacillus Helveticus and bifidobacterium Longum in people with Major Depression, run by Dr Sadia yasir at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn whether adding psychobiotics (a combination of Lactobacillus helveticus and Bifidobacterium longum) to standard antidepressant treatment works better than antidepressants alone for adults with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Lactobacillus Helveticus and bifidobacterium Longum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with major depressive disorder (According to Diagnostic \& Statistical Manual-5 criteria (as per operational definition)
- Age 18 to 60 years
- Both genders
- Patients who are able to speak and understand Urdu/ English language.
- Patients who are on stable doses of oral selective serotonin reuptake inhibitors for at least two weeks prior to enrollment in the study
- Patients with cut off score of > 24 as assessed by 17 item clinician administered Hamilton depression rating scale.
Who cannot join
- Severe psychiatric comorbidities (schizophrenia, bipolar disorder, co morbid substance use)
- Individuals with weakened immune systems: This includes patients undergoing chemotherapy, transplant recipients, and people with conditions like HIV/AIDS.
- Individuals on chronic medication: People on chronic pharmacological therapy, especially with anti-inflammatory drugs or who have recently used antibiotics in last 2 weeks.
- Pregnant or lactating women
- Current use of probiotics or prebiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arooj Fatima Senior Registrar, Psychiatry Department, MBBS, MD Psychiatry contact
Pakistan1 site, 1 recruiting
- Recruiting
Allama Iqbal Medical College, Jinnah Hospital Lahore
Lahore, Punjab Province, 54550
Head Of Department, PSYCHIATRY DEPARTMENT, +923334746639, psychjhl@aimc.edu.pk
AROOJ FATIMA, MBBS, MD PSY
About this study
Official title: Effect of Psychobiotics (Combined Lactobacillus Helveticus and Bifidobacterium Longus) With Standard Antidepressants in Treatment of Major Depressive Disorder.
The goal of this clinical trial is to learn whether adding psychobiotics (a combination of Lactobacillus helveticus and Bifidobacterium longum) to standard antidepressant treatment works better than antidepressants alone for adults with major depressive disorder. The study will also learn about the safety of taking these psychobiotics with antidepressants.
The main questions it aims to answer are:
Read more
- Does adding psychobiotics lower depression symptoms more than a placebo (a look-alike capsule with no active ingredients)?
- Is it safe and well tolerated when taken with standard antidepressant treatment?
Researchers will compare psychobiotic capsules with placebo capsules to see whether psychobiotics improve depression symptoms when used together with standard antidepressants.
Participants will:
- Continue taking their prescribed antidepressant medicine. Be randomly assigned to receive either a psychobiotic capsule or a placebo capsule once daily for 6 weeks.
- Complete depression assessments at the start of the study and again at 3 and 6 weeks.
- Attend regular follow-up visits so researchers can monitor symptoms, side effects, and overall progress
Read the detailed description
Major depressive disorder (MDD) is a leading cause of disability worldwide, and many patients experience only partial improvement with antidepressant treatment alone. Increasing evidence suggests that the gut-brain axis plays an important role in the pathophysiology of depression. Psychobiotics, including Lactobacillus helveticus and Bifidobacterium longum, may improve depressive symptoms by modulating the gut microbiota, reducing inflammation, and influencing neurochemical pathways.
This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive psychobiotic therapy in adults with MDD receiving standard antidepressant treatment. Participants will continue their prescribed antidepressant medication and will be randomly assigned to receive either a psychobiotic capsule containing Lactobacillus helveticus and Bifidobacterium longum or a matching placebo once daily for 6 weeks.
Depression severity will be assessed at baseline, Week 3, and Week 6 using validated rating scales. Safety and tolerability will be evaluated through adverse event monitoring, treatment adherence, and regular follow-up visits.
The primary objective is to determine whether adjunctive psychobiotic therapy produces a greater reduction in depressive symptoms compared with placebo. Secondary objectives include evaluating safety, tolerability, treatment adherence, patient satisfaction, and quality of life. The findings will provide evidence on whether psychobiotics are an effective and safe adjunct to antidepressant therapy in adults with major depressive disorder.
- Conditions
- Major Depression
- Being tested
- Lactobacillus Helveticus and bifidobacterium Longum, Placebo Capsule(s)
- Keywords
- Psychobiotics, Major Depressive Disorder, Lactobacillus Helveticus, Bifidobacterium longum, Gut-Brain Axis, Selective Serotonin Reuptake Inhibitors (SSRIs), Adjunctive Therapy, Placebo-Controlled Trial, Hamilton Depression Rating Scale (HDRS-17)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Helveticus and bifidobacterium LongumDietary supplement
Also called psychobiotics
This study uses a specific combination of two well-studied psychobiotic strains-Lactobacillus helveticus R0052 (1.8 billion CFU) and Bifidobacterium longum R0175 (1.2 billion CFU). These strains have been selected because they may support communication between the gut and the brain and help improve mood when used alongside standard antidepressant treatment.
Placebo Capsule(s)Other
A placebo capsule is an orally administered capsule formulated with inert gelatin and no active ingredients. It has no psychobiotic potential and is pharmacologically inactive. The capsule is not expected to affect study outcomes or interact with oral selective serotonin reuptake inhibitors (SSRIs)
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Active comparator | People who are recieving Psychobiotics as an adjunct to the standard treatment. Receives: Dietary Supplement: Lactobacillus Helveticus and bifidobacterium Longum |
| Placebo Comparator | Placebo comparator | people who will be given placebo capsules along with standard treatment Receives: Other: Placebo Capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score
The primary outcome is the difference in the mean change in the 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to Week 6 between participants receiving psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) plus standard antidepressant treatment and those receiving placebo plus standard antidepressant treatment. Higher reductions in HDRS-17 scores indicate greater improvement in depressive symptoms.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start31 Jan 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Sadia yasir
- Sponsor type
- University, hospital or other
- Collaborators
- Allama Iqbal Medical College, Jinnah Hospital
- Responsible party
- Sponsor-investigator, Dr Sadia yasir, Jinnah Hospital
- Investigators
- Sadia Yasir, MBBS FCPS, Study chair, Jinnah hospital lahore/ Allama Iqbal Medical college lahore, PakistanArooj Fatima, Principal investigator, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691749
- Sponsor's protocol ID
- ERB 198/06/01-01-2026/AIMC/JHL
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychobiotics (Combined Lactobacillus Helveticus and Bifidobacterium Longus) With Standard Antidepressants in Treatment of Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT07691749
- Acronym / sponsor ID
- ERB 198/06/01-01-2026/AIMC/JHL
- Conditions
- Major Depression
- Keywords
- Psychobiotics, Major Depressive Disorder, Lactobacillus Helveticus, Bifidobacterium longum, Gut-Brain Axis, Selective Serotonin Reuptake Inhibitors (SSRIs), Adjunctive Therapy, Placebo-Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Dr Sadia yasirUniversity, hospital or other
- Collaborators
- Allama Iqbal Medical College, Jinnah Hospital
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether adding psychobiotics (a combination of Lactobacillus helveticus and Bifidobacterium longum) to standard antidepressant treatment works better than antidepressants alone for adults with major depressive disorder. The study will also learn about the safety of taking these psychobiotics with antidepressants.
The main questions it aims to answer are:
- Does adding psychobiotics lower depression symptoms more than a placebo (a look-alike capsule with no active ingredients)?
- Is it safe and well tolerated when taken with standard antidepressant treatment?
Researchers will compare psychobiotic capsules with placebo capsules to see whether psychobiotics improve depression symptoms when used together with standard antidepressants.
Participants will:
- Continue taking their prescribed antidepressant medicine. Be randomly assigned to receive either a psychobiotic capsule or a placebo capsule once daily for 6 weeks.
- Complete depression assessments at the start of the study and again at 3 and 6 weeks.
- Attend regular follow-up visits so researchers can monitor symptoms, side effects, and overall progress
Detailed description
Major depressive disorder (MDD) is a leading cause of disability worldwide, and many patients experience only partial improvement with antidepressant treatment alone. Increasing evidence suggests that the gut-brain axis plays an important role in the pathophysiology of depression. Psychobiotics, including Lactobacillus helveticus and Bifidobacterium longum, may improve depressive symptoms by modulating the gut microbiota, reducing inflammation, and influencing neurochemical pathways.
This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive psychobiotic therapy in adults with MDD receiving standard antidepressant treatment. Participants will continue their prescribed antidepressant medication and will be randomly assigned to receive either a psychobiotic capsule containing Lactobacillus helveticus and Bifidobacterium longum or a matching placebo once daily for 6 weeks.
Depression severity will be assessed at baseline, Week 3, and Week 6 using validated rating scales. Safety and tolerability will be evaluated through adverse event monitoring, treatment adherence, and regular follow-up visits.
The primary objective is to determine whether adjunctive psychobiotic therapy produces a greater reduction in depressive symptoms compared with placebo. Secondary objectives include evaluating safety, tolerability, treatment adherence, patient satisfaction, and quality of life. The findings will provide evidence on whether psychobiotics are an effective and safe adjunct to antidepressant therapy in adults with major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Active comparator | Dietary Supplement: Lactobacillus Helveticus and bifidobacterium LongumPeople who are recieving Psychobiotics as an adjunct to the standard treatment. |
| Placebo Comparator | Placebo comparator | Other: Placebo Capsule(s)people who will be given placebo capsules along with standard treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed with major depressive disorder (According to Diagnostic \& Statistical Manual-5 criteria (as per operational definition)
- Age 18 to 60 years
- Both genders
- Patients who are able to speak and understand Urdu/ English language.
- Patients who are on stable doses of oral selective serotonin reuptake inhibitors for at least two weeks prior to enrollment in the study
Key exclusion criteria (5 listed)
- Severe psychiatric comorbidities (schizophrenia, bipolar disorder, co morbid substance use)
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 |
|---|---|---|
| Lactobacillus Helveticus and bifidobacterium LongumAlso: psychobioticsThis study uses a specific combination of two well-studied psychobiotic strains-Lactobacillus helveticus R0052 (1.8 billion CFU) and Bifidobacterium longum R0175 (1.2 billion CFU). These strains have been selected because they may support communication between the gut and the brain and help improve mood when used alongside standard antidepressant treatment. | Dietary supplement | Interventional Arm |
| Placebo Capsule(s)A placebo capsule is an orally administered capsule formulated with inert gelatin and no active ingredients. It has no psychobiotic potential and is pharmacologically inactive. The capsule is not expected to affect study outcomes or interact with oral selective serotonin reuptake inhibitors (SSRIs) | Other | Placebo Comparator |
Primary outcome
Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score
Time frame: Baseline to Week 6
The primary outcome is the difference in the mean change in the 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to Week 6 between participants receiving psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) plus standard antidepressant treatment and those receiving placebo plus standard antidepressant treatment. Higher reductions in HDRS-17 scores indicate greater improvement in depressive symptoms.
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 30 Sep 2026.
- 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.
Arooj Fatima Senior Registrar, Psychiatry Department, MBBS, MD Psychiatry contact
Sadia Yasir, MBBS FCPS study chair
Jinnah hospital lahore/ Allama Iqbal Medical college lahore, Pakistan
Arooj Fatima principal investigator
Jinnah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Helveticus and bifidobacterium Longum in people with Major Depression, run by Dr Sadia yasir at 1 site in Pakistan.
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 6 inclusion and 5 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arooj Fatima Senior Registrar, Psychiatry Department, MBBS, MD Psychiatry (+923314567690, aroojfatima47@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.