Using probiotics to help manage depression in cancer patients
Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies
This study is testing whether a special probiotic can help improve mood and reduce anxiety in cancer patients who have had surgery and are getting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT06496438 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a probiotic formulation with psychobiotic properties on depression and anxiety in patients who have undergone surgery for digestive cancer and are currently receiving chemotherapy. It is a double-blind, randomized, placebo-controlled trial conducted at the AHEPA University Hospital in Thessaloniki, Greece. The trial aims to determine whether these probiotics can improve mental health outcomes in this vulnerable patient population. Participants will be monitored for changes in their depression and anxiety levels throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a confirmed diagnosis of digestive tract cancer who have undergone surgery and are currently receiving chemotherapy.
Not a fit: Patients with pre-existing psychiatric disorders or those currently taking probiotic supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-pharmacological treatment option for improving mental health in cancer patients undergoing chemotherapy.
How similar studies have performed: While the use of psychobiotics in mental health is a relatively novel approach, preliminary studies have shown promise in similar contexts, though this specific application in cancer patients is untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 and \<85 * Histologically confirmed diagnosis of digestive tract malignancy, the tumor having been surgically resected and the patient currently undergoing chemotherapy sessions * Informed consent obtained to participate in the study Exclusion Criteria: * Not understanding the Greek language * Dementia * Pre-existing psychiatric disorders * Already receiving probiotic supplements (apart from yoghurt) * Participation in another clinical trial * Consumption of less than the 90% of treatment sachets/doses (verified by the sachets returned) * Those having received during hospitalization other probiotic formulations
Where this trial is running
Thessaloniki
- AHEPA University Hospital — Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Katerina Kotzampassi, Dr.
- Email: kakothe@yahoo.com
- Phone: +306944434107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.