Anxiety DepressionEarly Phase 1NCT07640490
Influence of Oral Probiotics on Anxiety and Depression in Adolescents After Non-cardiac and Non-gastrointestinal Surgeries: A Prospective, Double-blind, Placebo-controlled Study
A Early Phase 1 study testing C Group and P Group in people with Anxiety Depression, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 12-17 years old and American Society of Anesthesiologists (ASA) physical status I and II are selected as subjects. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- C Group and P Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2025to 2 May 2026
- Phase
- Early Phase 1
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8 years ≤ age ≤17 years;
- Patients who plan to undergo elective surgery under general anesthesia, and the operation time is 1-2 hours;
- ASA grade I-II
- The body mass index falls within the normal range, which is 18.5 - 23.9 kg/m2.
Who cannot join
- The patient has psychological disorders, including but not limited to bipolar affective disorder.
- Eating disorder
- No informed consent form
- Due to certain serious diseases, one needs to take medication for a long period of time.
- Personality disorder
- Has undergone or needs to undergo gastrointestinal surgery
- Have taken antibiotics or probiotics within the past 8 weeks
- Pure vegetarian diet
Trial locations and contacts
1 site in 1 country.
About this study
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 12-17 years old and American Society of Anesthesiologists (ASA) physical status I and II are selected as subjects. Oral probiotics is used as intervention before surgery, vital signs data, serum IL-1, IL-6, BDNF,5-HT and other inflammatory indicators are collected before surgery and after non-cardiac and non-gastrointestinal surgeries, and the incidence and degree of anxiety and depression are evaluated after non-cardiac and non-gastrointestinal surgeries. To determine the effect of esketamine on reducing anxiety and depression in adolescents after non-cardiac and non-gastrointestinal surgeries, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after non-cardiac and non-gastrointestinal surgeries.
- Conditions
- Anxiety Depression
- Being tested
- C Group, P Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C GroupDrug
Continuous oral administration of probiotics
P GroupDrug
Take a placebo, which looks no different from a probiotic agent
| Study group | Role | What they receive |
|---|---|---|
| Continuous oral administration of probiotics（Bifidobacterium Tetra-Strain Live Bacteria Tablets） | Experimental | Selincon Receives: Drug: C Group |
| Take a placebo, which looks no different from a probiotic agent | Placebo comparator | Not described Receives: Drug: P Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety scale scores after surgery during 2 month
Hamilton Anxiety Rating Scale (HAMA)：The lower the score, the better the result
Measured: 2 months
Depression scale scores after surgery during 2 month
Beck Depression Inventory (BDI)：The lower the score, the better the result
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start2 Aug 2025
- Primary completion2 May 2026
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640490
- Sponsor's protocol ID
- HenanGY
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Probiotics on Anxiety and Depression in Adolescents After Non-cardiac and Non-gastrointestinal Surgeries: A Prospective, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07640490
- Acronym / sponsor ID
- HenanGY
- Conditions
- Anxiety Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 10 Jun 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.
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 12-17 years old and American Society of Anesthesiologists (ASA) physical status I and II are selected as subjects. Oral probiotics is used as intervention before surgery, vital signs data, serum IL-1, IL-6, BDNF,5-HT and other inflammatory indicators are collected before surgery and after non-cardiac and non-gastrointestinal surgeries, and the incidence and degree of anxiety and depression are evaluated after non-cardiac and non-gastrointestinal surgeries. To determine the effect of esketamine on reducing anxiety and depression in adolescents after non-cardiac and non-gastrointestinal surgeries, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after non-cardiac and non-gastrointestinal surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous oral administration of probiotics（Bifidobacterium Tetra-Strain Live Bacteria Tablets） | Experimental | Drug: C GroupSelincon |
| Take a placebo, which looks no different from a probiotic agent | Placebo comparator | Drug: P Group |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8 years ≤ age ≤17 years;
- Patients who plan to undergo elective surgery under general anesthesia, and the operation time is 1-2 hours;
- ASA grade I-II
- The body mass index falls within the normal range, which is 18.5 - 23.9 kg/m2.
Key exclusion criteria (8 listed)
- The patient has psychological disorders, including but not limited to bipolar affective disorder.
- Eating disorder
- No informed consent form
- Due to certain serious diseases, one needs to take medication for a long period of time.
- Personality disorder
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 |
|---|---|---|
| C GroupContinuous oral administration of probiotics | Drug | Continuous oral administration of probiotics（Bifidobacterium Tetra-Strain Live Bacteria Tablets） |
| P GroupTake a placebo, which looks no different from a probiotic agent | Drug | Take a placebo, which looks no different from a probiotic agent |
Primary outcome
Anxiety scale scores after surgery during 2 month
Time frame: 2 months
Hamilton Anxiety Rating Scale (HAMA)：The lower the score, the better the result
Depression scale scores after surgery during 2 month
Time frame: 2 months
Beck Depression Inventory (BDI)：The lower the score, the better the result
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 10 Jun 2026.
Related trials for Anxiety Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 Early Phase 1 study testing C Group and P Group in people with Anxiety Depression, run by Henan Provincial People's Hospital at 1 site in China.
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 4 inclusion and 8 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 10 Jun 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 China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anxiety scale scores after surgery during 2 month (time frame: 2 months). The study lists 2 primary outcomes in all. 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 10 Jun 2026.