Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390176
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-21
Brief Title:
Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Lactobacillus Rhamnosus LGG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Radiation therapy is a common treatment modality in the management of head and neck malignancies However head and neck tumors often have some adverse reactions when receiving radiation therapy such as dry mouth change of taste oral mucositis etc Among them the incidence of oral mucositis is more than 90 and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50 Severe oral mucositis seriously affects the quality of survival of patients
Lactobacillus rhamnosus GG LGG is a type of lactic acid bacterium which is an important component of the microbiota in many parts of the human body
Lactobacillus rhamnosus GG LGG is a lactic acid bacterium found in the human body extensively researched for its probiotic properties It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma LGG adheres well to epithelial layers produces a protective biofilm and modulates immune responses It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula Additionally a daily dosage of 3109 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects
Lactobacillus rhamnosus GG LGG is a type of lactic acid bacterium which is an important component of the microbiota in many parts of the human body
Lactobacillus rhamnosus GG LGG is a lactic acid bacterium found in the human body extensively researched for its probiotic properties It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma LGG adheres well to epithelial layers produces a protective biofilm and modulates immune responses It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula Additionally a daily dosage of 3109 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects
Detailed Description:
Radiotherapy RT is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy Despite improvements in RT equipment and techniques there are still a variety of acute oral complications including oral mucositis OM xerostomia taste dysfunction and oral infection OM is one of the most common acute radiation-related toxicity in head and neck malignant tumor patients receiving RT and approximately 5070 of patients experience severe oral mucositis SOM The painful inflammation and ulceration associated with OM not only profoundly affect patients ability to eat swallow and speak but also decrease patients tolerance to anti-cancer treatment seriously impairing patients quality of life QoL and causing interruptions and cancellations of cancer treatment Standard treatment for OM focuses on pain control rehydration and good oral hygiene For patients with hematopoietic stem cell transplantation palifermin keratinocyte growth factor-1 is recommended Although some clinical strategies for OM such as non-steroidal anti-inflammatory drugs mucosal protective agents growth factors and cytokines antibacterial and pain relief drugs have been recommended by the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology MASCCISOO the therapeutic benefit is limited6 Thus it is crucial to develop effective drugs or treatment strategies to decrease radiation-induced mucosal toxicity
LGG has been used in clinical trials for the prevention and treatment of oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma including nasopharyngeal carcinoma It was isolated from a healthy adults fecal sample and possesses good growth characteristics and the ability to adhere to epithelial layers It has long been one of the most extensively researched and applied probiotic strains utilized in various commercially available probiotic products Its beneficial effects have been extensively studied in clinical trials and human intervention studies including its role in preventing and treating gastrointestinal infections and diarrhea stimulating immune responses and even preventing certain allergic symptoms
In addition to producing a biofilm that mechanically protects the mucosa reduces epithelial cell apoptosis and maintains cell cytoskeleton integrity LGG also exhibits immunomodulatory properties It protects the epithelium from radiation damage by reducing TLR-2COX-2 activation and regulates the protein levels of pro-inflammatory cytokines tumor necrosis factor-alpha interleukin-6 and monocyte chemotactic protein-1 in tissues actively participating in host defense processes It can also reduce the number of pathogenic bacteria and regulate colony distribution
The occurrence and development of radiation-induced oral mucositis are closely related to cellular immunity A series of pro-inflammatory cytokines produced by immune cells such as tumor necrosis factor-alpha and interleukin-6 will positively feedback to amplify the inflammatory response of radiation-induced oral mucositis
Regarding safety LGG can be added to infant formula as a probiotic Furthermore studies have shown that a dosage of 3109 CFU of LGG per day can be used to treat irritable bowel syndrome IBS without causing disease or toxicity in the body Therefore Lactobacillus rhamnosus GG holds promise as a potential approach for preventing and treating radiation-induced oral mucositis
LGG has been used in clinical trials for the prevention and treatment of oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma including nasopharyngeal carcinoma It was isolated from a healthy adults fecal sample and possesses good growth characteristics and the ability to adhere to epithelial layers It has long been one of the most extensively researched and applied probiotic strains utilized in various commercially available probiotic products Its beneficial effects have been extensively studied in clinical trials and human intervention studies including its role in preventing and treating gastrointestinal infections and diarrhea stimulating immune responses and even preventing certain allergic symptoms
In addition to producing a biofilm that mechanically protects the mucosa reduces epithelial cell apoptosis and maintains cell cytoskeleton integrity LGG also exhibits immunomodulatory properties It protects the epithelium from radiation damage by reducing TLR-2COX-2 activation and regulates the protein levels of pro-inflammatory cytokines tumor necrosis factor-alpha interleukin-6 and monocyte chemotactic protein-1 in tissues actively participating in host defense processes It can also reduce the number of pathogenic bacteria and regulate colony distribution
The occurrence and development of radiation-induced oral mucositis are closely related to cellular immunity A series of pro-inflammatory cytokines produced by immune cells such as tumor necrosis factor-alpha and interleukin-6 will positively feedback to amplify the inflammatory response of radiation-induced oral mucositis
Regarding safety LGG can be added to infant formula as a probiotic Furthermore studies have shown that a dosage of 3109 CFU of LGG per day can be used to treat irritable bowel syndrome IBS without causing disease or toxicity in the body Therefore Lactobacillus rhamnosus GG holds promise as a potential approach for preventing and treating radiation-induced oral mucositis
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