Clinical trial · Interventional
Probiotics for Depression in Cancer Patients
Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Anxiety and depressive disorders are quite prevalent in the general population. In 2015, it was estimated that 3.6% of the world population (around 264 million individuals) live with depression and 4.4% (around 322 million) with anxiety, while in the recent years of the COVID-19 pandemic, the prevalence of these disorders has significantly increased. According to the American Psychiatric Association, in 2013 depression was defined as a serious mental illness characterized by decreased mood lasting more than 15 days, a lack of interest, and (even) apathy to normal daily activities. Depression, particularly in its severe form - the major depressive disorder (MDD), is the second leading cause of disability and the most common emotional disorder. Recent research data indicate that this psychiatric disorder, as also similar neuropsychological conditions (Parkinson's, autism, etc.) have, as their main substrate, a disturbance in the diversity of the gut microbiome. More specifically, it has been shown that there is a direct and bidirectional communication between gut and brain - the "gut-brain-axis". The gut, through its microbiome, communicates with the brain by means of neural, immunological, and metabolic pathways, either directly, through the vagus nerve or indirectly, either through the microbiome immunomodulation or the tryptophan pathway, or by the production of various neuroactive molecules. The disturbance in the diversity of the gut microbiome, termed dysbiosis, involves changes in the composition and the number of bacteria genera; and is causatively related to depression via the gut-brain axis. The transmission of nerve impulses, both via the hypothalamic-pituitary-adrenal axis and via the vagus nerve is disrupted by dysbiosis, leading to anxiety and depression, or, conversely, stressful conditions, more particularly emotional stress, which triggers an imbalance in the hypothalamic-pituitary-adrenal axis, leading to systemic immune responses and intestinal dysbiosis. This imbalance can clinically manifest with alterations in digestive tract function, knowledge accepted since the beginning of the previous century. Nowadays, there is considerable evidence that the gut microbiome represents a novel anti-depressant and the term "psychobiotics" has been used to describe those species of probiotic bacteria excreting mental health benefits. Certain Bifidobacterium and Lactobacillus species have already demonstrated, both experimentally and in clinical studies, their capability to improve mood, reduce anxiety, and enhance cognitive function. On these grounds, it is reasonable to raise the hypothesis that, by restoring the diversity of the gut microbiome, and thus enhancing the population of these specific probiotic species - termed 'psychobiotics', due to their specified functions, - could at least lead to an improvement in neuro-psychological disorders through gut-brain-axis remodeling.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Probiotics | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Psychobiotics | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Psychobiotics
- description
- Patients operated on for gastrointestinal cancer and currently undergoing chemotherapy will be randomized to receive a probiotic regime "therapy" with four psychobiotics \[one sachet twice daily for a month\].
- interventionNames
- Dietary Supplement: Psychobiotics
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients operated on for gastrointestinal cancer and currently undergoing chemotherapy will be randomized to receive placebo sachets which will be identical to the probiotic regime.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Depression changes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDGrassi L, Caruso R, Riba MB, Lloyd-Williams M, Kissane D, Rodin G, McFarland D, Campos-Rodenas R, Zachariae R, Santini D, Ripamonti CI; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Anxiety and depression in adult cancer patients: ESMO Clinical Practice Guideline. ESMO Open. 2023 Apr;8(2):101155. doi: 10.1016/j.esmoop.2023.101155. Epub 2023 Mar 14. PMID 37087199
- BACKGROUNDSonali S, Ray B, Ahmed Tousif H, Rathipriya AG, Sunanda T, Mahalakshmi AM, Rungratanawanich W, Essa MM, Qoronfleh MW, Chidambaram SB, Song BJ. Mechanistic Insights into the Link between Gut Dysbiosis and Major Depression: An Extensive Review. Cells. 2022 Apr 16;11(8):1362. doi: 10.3390/cells11081362. PMID 35456041
- BACKGROUNDButler MI, Sandhu K, Cryan JF, Dinan TG. From isoniazid to psychobiotics: the gut microbiome as a new antidepressant target. Br J Hosp Med (Lond). 2019 Mar 2;80(3):139-145. doi: 10.12968/hmed.2019.80.3.139. PMID 30860919
- BACKGROUNDMisra S, Mohanty D. Psychobiotics: A new approach for treating mental illness? Crit Rev Food Sci Nutr. 2019;59(8):1230-1236. doi: 10.1080/10408398.2017.1399860. Epub 2017 Nov 30. PMID 29190117
- BACKGROUNDChidambaram SB, Essa MM, Rathipriya AG, Bishir M, Ray B, Mahalakshmi AM, Tousif AH, Sakharkar MK, Kashyap RS, Friedland RP, Monaghan TM. Gut dysbiosis, defective autophagy and altered immune responses in neurodegenerative diseases: Tales of a vicious cycle. Pharmacol Ther. 2022 Mar;231:107988. doi: 10.1016/j.pharmthera.2021.107988. Epub 2021 Sep 16. PMID 34536490
- BACKGROUNDKim JK, Han SK, Joo MK, Kim DH. Buspirone alleviates anxiety, depression, and colitis; and modulates gut microbiota in mice. Sci Rep. 2021 Mar 17;11(1):6094. doi: 10.1038/s41598-021-85681-w. PMID 33731795
- BACKGROUNDZhou L, Foster JA. Psychobiotics and the gut-brain axis: in the pursuit of happiness. Neuropsychiatr Dis Treat. 2015 Mar 16;11:715-23. doi: 10.2147/NDT.S61997. eCollection 2015.