CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 132 target
Drug / intervention
Lactobacillus rhamnosus GG powder +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06390176
NCT06390176N/AUnknown

Lactobacillus Rhamnosus LGG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial

West China Hospital·interventional·Posted Apr 30, 2024·Updated Apr 30, 2024

In Brief

A clinical study evaluating Lactobacillus rhamnosus GG powder, Placebo-containing tablets, and 1 other intervention for Oral Mucositis. Targeting 132 participants across 1 site.

Detailed 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 3×10\^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Mucositis
CountriesChina
Collaborators--

Timeline

N/AUnknownOverdue
202420252026
First PostedApr 30, 2024
Enrollment StartNov 10, 2023
Primary CompletionMar 31, 2025
TodayJul 1, 2026
Enrollment to primary: 1.4 yearsPosted 2.2 years ago

Interventions

Lactobacillus rhamnosus GG powderdietary

Lactobacillus rhamnosus GG powder (PROBIOTICS Powder, USA) contained no less than 5×10\^8 CFU viable cells of Lactobacillus rhamnosus GG as the active ingredient.

Placebo-containing tabletsdietary

Starch preparations that look and taste like Lactobacillus rhamnosus GG powder

Radiotherapyradiation

One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy, with radiotherapy using intensity-modulated radiotherapy techniques.