the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Thyroid cancer is a common neck malignancy. Currently, total thyroidectomy or subtotal thyroidectomy is the main method for the treatment of thyroid cancer patients. However, some thyroid cancer may still have residual thyroid tissue after operation. Therefore, in the differentiated thyroid In the treatment of cancer, iodine 131 treatment is mainly used because iodine 131 can emit high-energy beta rays, destroying the residual tissue of thyroid cancer and achieving good therapeutic goals. However, in the treatment of iodine-131, certain salivary glands are inevitably damaged, and the patient will have dry mouth symptoms. After the same treatment with iodine-131, some patients will experience gastrointestinal reactions such as nausea and vomiting. The therapeutic efficacy of iodine-131 depends on the lesion's uptake of iodine-131, which requires an increase in serum TSH levels. All patients in this study had stopped taking thyroid hormone for 3-4 weeks before iodine 131 treatment, making serum The TSH level is greater than 30 mU/L. At this time, the patient is in hypothyroidism. People with hypothyroidism experience dry mouth, dry skin, constipation, pain, cold, poor memory, depression, and weight gain. Many studies have pointed out that some cancer treatments, such as chemotherapy and radiotherapy, also have an impact on the microbial flora. However, studies on the relationship between microecology, hypothyroidism and iodine-131 treatment, probiotics in the prevention of hypothyroidism and iodine-131 treatment The link between the effects of side effects remains unclear. Therefore, the team will conduct a correlation study between microbes and hypothyroidism, iodine-131 treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.

NCT06134830

Thyroid Cancer

NOT_YET_RECRUITING

Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients

NCT00435851

Thyroid Cancer

UNKNOWN PHASE3

Hyperthyroid Follow-Up Study

NCT02989103

All-Cause Mortality Circulatory and Other Disease Mortality Thyroid and Other Cancer Mortality

COMPLETED

The Oral Microbiota is Associated With Autoimmune Thyroiditis

NCT03447093

Microbiota

UNKNOWN

Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma

NCT00673010

Thyroid Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thyroid cancer is a common neck malignancy and it mainly affects thyroid follicular cells or parafollicular cells. Thyroid cancer in various tumors in the body, the ratio can reach 1.2% to 2.3%. Thyroid cancer can be divided into differentiated thyroid cancer, squamous cell carcinoma, undifferentiated carcinoma, and medullary carcinoma, among which the incidence of differentiated thyroid carcinoma is more than 90%. At present, total thyroidectomy or subtotal thyroidectomy is the main method for the treatment of thyroid cancer patients, but some thyroid cancer may still have residual thyroid tissue after operation. Therefore, in the treatment of differentiated thyroid cancer, iodine 131 is mainly used. Treatment, because iodine 131 can emit high-energy beta rays, destroying the residual tissue of thyroid cancer, to achieve good therapeutic purposes. However, due to the presence of sodium iodine symporter in salivary glands and thyroid, it is inevitable that certain salivary glands will be damaged in the treatment of iodine 131, and patients will have dry mouth symptoms. Some patients with nausea 131 will also experience nausea and vomiting. Gastrointestinal reaction. Iodine 131 treatment is divided into two steps: 1 removal of residual thyroid tissue; 2 removal of cancer lesions and metastases. The curative effect of 131I depends on the lesion's uptake of iodine-131, which requires an increase in serum TSH levels. All patients in this study had stopped taking thyroid hormone for 3 to 4 weeks before iodine-131 treatment. The TSH level is greater than 30 mU/L. At this time, the patient is in hypothyroidism. People with hypothyroidism experience dry mouth, dry skin, constipation, pain, cold, poor memory, depression, and weight gain. Many studies have pointed out that some cancer treatments, such as chemotherapy and radiotherapy, also have an impact on the microbial flora. However, studies on the relationship between microecology, hypothyroidism and iodine-131 treatment, probiotics in the prevention of hypothyroidism and iodine-131 treatment The link between the effects of side effects remains unclear. Therefore, the team will conduct a correlation study between microbes and hypothyroidism, iodine-131 treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microbiota

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic

Taking probiotics containing Bifidobacterium infantis, Lactobacillus acidophilus and Enterococcus faecalis for 30 days

Group Type EXPERIMENTAL

Probiotic

Intervention Type DRUG

Evaluate probiotics for preventing adverse effects of hypothyroidism and improvement of side effects caused by 131I treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic

Evaluate probiotics for preventing adverse effects of hypothyroidism and improvement of side effects caused by 131I treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Complex-probiotic-preparation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 years old, 65 years old, male and female;
* Histologically confirmed differentiated thyroid cancer;
* After total thyroidectomy, patients who have undergone 131I therapy for the second time or more after recurrence or regional lymph node metastasis after 131I treatment for the first time are required. Or after the first 131I treatment, patients with differentiated thyroid who were treated with 131I for more than 3 months.

Exclusion Criteria

* Use of various antibiotics within three months;
* Having a history of alcoholism for more than 2 years and a history of smoking throughout the year;
* pregnancy or lactation;
* having oral, respiratory and gastrointestinal diseases;
* has a variety of metabolic diseases, such as obesity, hypertension, diabetes, stones, various liver diseases, etc.;
* having other autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, etc.;
* History of gastrointestinal surgery or other recent surgical history;
* Has a family history of genetic disease, mental illness, etc.;
* Research subjects are participating in other research topics;
* The researchers believe that other reasons are not suitable for continuing clinical trials;
* Undifferentiated thyroid cancer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes