Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496438
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-30
Brief Title:
Probiotics for Depression in Cancer Patients
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anxiety and depressive disorders are quite prevalent in the general population In 2015 it was estimated that 36 of the world population around 264 million individuals live with depression and 44 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 Parkinsons 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
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 Parkinsons 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
Detailed Description:
Based on the assumption that 1 at least one third of digestive cancer patients operated on - and probably more when surgery is followed by chemotherapy sessions - suffer from anxiety and depression 2 psychobiotics can beneficially modify the gut microbiome 3 psychobiotics can improve the mental health of patients suffering from depression and 4 there is no other study on the use of psychobiotics in anxiety andor depression symptoms in patients operated on for digestive tract malignancies and subjected to chemotherapy thereafter the present study was designed to investigate the ability of a probiotic formulation containing bacteria with known psychobiotic properties to change the depression and anxiety status of digestive cancer patients undergoing chemotherapy postoperatively
This study will be a prospective double-blind randomized study against placebo in patients operated on for digestive cancer and undergoing chemotherapy The study will be conducted in the 1st Surgical Department of the Aristotle University of Thessaloniki at the AHEPA University Hospital of Thessaloniki Greece in collaboration with the Outpatient Surgical Oncology Unit Permission has already been obtained from the Scientific Council of the AHEPA Hospital Approval Number 313472023
The oncologist involved in the study protocol will be responsible for randomization She will inform the patients who meet the study entry criteria of the purpose of the study and receiving their written consent after detailed information Patients having signed the informed consent will then be assigned at random in a 11 ratio to receive placebo or probiotic regime treatment according to a computer-based table randomizedcom The randomization will be blinded to the study statistician as well as to the physicians in contact with patients for interviews to facilitate the collection of answers to the questionnaires Sealed envelops will be used to ensure blinding Only the study coordinator will be aware of the content having no further involvement with the patients Each patient having signed the consent will then receive a unique code-number being a combination of the anatomical location of the tumor the patients serial number a capital letter A or B - blindly indicating the treatment groups - and a small letter abc indicating the physician who contacts each patient
After patient aggrees to be included in the study the demographic data that will be obtained in relation to each patient are gender age body weight in kilograms and height in meters to calculate BMI reported weight loss in kilograms since the disease diagnosis marital status smoking habits no smoking or number of cigarettesday alcohol consumption type and volume and the possible use of tranquilizers mg of active substance Optionally patients will give information as to their educational level 1st 2nd or 3rd grade annual income 10000 10001-30000 30001year and health care insurance public private both From their medical records cancer type and anatomical localization cancer stage TNM classification type of surgical intervention and co-morbidity indices Charlson Comorbidity Index will be obtained Additional information will be collated relating to the time lapse since diagnosis in days the time lapse from hospital discharge to starting chemotherapy in days and the time from starting chemotherapy to study entry in days
The probiotic regime under testing is a combination of 4 psychobiotics Lactobacillus rhamnosus Bifidobacterium animalis subsp lactis Bifidobacterium breve and Bifidobacterium longum at a dose of 1000000000CFU These for psychobiotics are the main ingredients of the commercially available formula LactoLevure ProbioMood UniPharma Athens Greece which also contains saffron and magnesium This formula is marketed for people with an anxious lifestyle who often suffer from symptoms such as low mood or fatigue as a result of stress
The placebo regime containing powdered glucose polymer will be identical in packaging appearance consistency and solubility in drinking water thus making it impossible to recognize which are placebo and which the therapeutic formulation Both will be identically standardized by the same pharmaceutical company Uni-Pharma Greece
Patients will be administered the treatment or the placebo daily - one sachet twice a day two hours after breakfast for 30 consecutive days At the follow-up appointment after treatment termination patients will be required to return any remaining sachets which they forgot to take Patients will be telephoned to remind a day before appointment Fifteen days after the start of treatment there will be telephone contact or a face-to-face contact if the new chemotherapy appointment coincides for the purpose of a rough out of the protocol assessment of the patients condition by the same physician who conducted the initial interview the purpose being to confirm that the patient is receiving the treatment and to un-officially obtain information on whether heshe is generally feeling better than previously
Two follow up evaluations will be held 1 month and 3 months after treatment begins
Patients will be evaluated by means of standardized questionnaires - officially translated and validated in the Greek language - for the quantification of depression emotional state anxiety quality of life physical weakness and pain
This study will be a prospective double-blind randomized study against placebo in patients operated on for digestive cancer and undergoing chemotherapy The study will be conducted in the 1st Surgical Department of the Aristotle University of Thessaloniki at the AHEPA University Hospital of Thessaloniki Greece in collaboration with the Outpatient Surgical Oncology Unit Permission has already been obtained from the Scientific Council of the AHEPA Hospital Approval Number 313472023
The oncologist involved in the study protocol will be responsible for randomization She will inform the patients who meet the study entry criteria of the purpose of the study and receiving their written consent after detailed information Patients having signed the informed consent will then be assigned at random in a 11 ratio to receive placebo or probiotic regime treatment according to a computer-based table randomizedcom The randomization will be blinded to the study statistician as well as to the physicians in contact with patients for interviews to facilitate the collection of answers to the questionnaires Sealed envelops will be used to ensure blinding Only the study coordinator will be aware of the content having no further involvement with the patients Each patient having signed the consent will then receive a unique code-number being a combination of the anatomical location of the tumor the patients serial number a capital letter A or B - blindly indicating the treatment groups - and a small letter abc indicating the physician who contacts each patient
After patient aggrees to be included in the study the demographic data that will be obtained in relation to each patient are gender age body weight in kilograms and height in meters to calculate BMI reported weight loss in kilograms since the disease diagnosis marital status smoking habits no smoking or number of cigarettesday alcohol consumption type and volume and the possible use of tranquilizers mg of active substance Optionally patients will give information as to their educational level 1st 2nd or 3rd grade annual income 10000 10001-30000 30001year and health care insurance public private both From their medical records cancer type and anatomical localization cancer stage TNM classification type of surgical intervention and co-morbidity indices Charlson Comorbidity Index will be obtained Additional information will be collated relating to the time lapse since diagnosis in days the time lapse from hospital discharge to starting chemotherapy in days and the time from starting chemotherapy to study entry in days
The probiotic regime under testing is a combination of 4 psychobiotics Lactobacillus rhamnosus Bifidobacterium animalis subsp lactis Bifidobacterium breve and Bifidobacterium longum at a dose of 1000000000CFU These for psychobiotics are the main ingredients of the commercially available formula LactoLevure ProbioMood UniPharma Athens Greece which also contains saffron and magnesium This formula is marketed for people with an anxious lifestyle who often suffer from symptoms such as low mood or fatigue as a result of stress
The placebo regime containing powdered glucose polymer will be identical in packaging appearance consistency and solubility in drinking water thus making it impossible to recognize which are placebo and which the therapeutic formulation Both will be identically standardized by the same pharmaceutical company Uni-Pharma Greece
Patients will be administered the treatment or the placebo daily - one sachet twice a day two hours after breakfast for 30 consecutive days At the follow-up appointment after treatment termination patients will be required to return any remaining sachets which they forgot to take Patients will be telephoned to remind a day before appointment Fifteen days after the start of treatment there will be telephone contact or a face-to-face contact if the new chemotherapy appointment coincides for the purpose of a rough out of the protocol assessment of the patients condition by the same physician who conducted the initial interview the purpose being to confirm that the patient is receiving the treatment and to un-officially obtain information on whether heshe is generally feeling better than previously
Two follow up evaluations will be held 1 month and 3 months after treatment begins
Patients will be evaluated by means of standardized questionnaires - officially translated and validated in the Greek language - for the quantification of depression emotional state anxiety quality of life physical weakness and pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None