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the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

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ClinicalTrials.gov Identifier: NCT03574051
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Microbiota Drug: Probiotic Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Distinct Shifts in the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Arm Intervention/treatment
Experimental: Probiotic
Taking probiotics containing Bifidobacterium infantis, Lactobacillus acidophilus and Enterococcus faecalis for 30 days
Drug: Probiotic
Evaluate probiotics for preventing adverse effects of hypothyroidism and improvement of side effects caused by 131I treatment
Other Name: Complex-probiotic-preparation




Primary Outcome Measures :
  1. The number of patients with improved side effects [ Time Frame: 4 weeks ]
    Improved side-effects in patients, such as reduced diarrhea and improved dry mouth symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574051


Contacts
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Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com

Locations
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China, Heilongjiang
First affiliated hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Yunwei Wei    +86-0451-85553099    hydwyw11@hotmail.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Study Director: Yunwei Wei First Affiliated Hospital of Harbin Medical University

Publications:
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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03574051     History of Changes
Other Study ID Numbers: Yunwei Wei 2018 -05-21
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:
oral microbiota
16S rRNA gene
thyroid cancer
iodine 131 treatment
fecal microbiota
radiotherapy

Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs