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the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

Primary Purpose

Microbiota

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Probiotic
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microbiota focused on measuring oral microbiota, 16S rRNA gene, thyroid cancer, iodine 131 treatment, fecal microbiota, radiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • First affiliated hospital of Harbin medical universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic

Arm Description

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

Outcomes

Primary Outcome Measures

The number of patients with improved side effects
Improved side-effects in patients, such as reduced diarrhea and improved dry mouth symptoms

Secondary Outcome Measures

Full Information

First Posted
June 19, 2018
Last Updated
July 12, 2018
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03574051
Brief Title
the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism
Official Title
Distinct Shifts in the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbiota
Keywords
oral microbiota, 16S rRNA gene, thyroid cancer, iodine 131 treatment, fecal microbiota, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Taking probiotics containing Bifidobacterium infantis, Lactobacillus acidophilus and Enterococcus faecalis for 30 days
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Complex-probiotic-preparation
Intervention Description
Evaluate probiotics for preventing adverse effects of hypothyroidism and improvement of side effects caused by 131I treatment
Primary Outcome Measure Information:
Title
The number of patients with improved side effects
Description
Improved side-effects in patients, such as reduced diarrhea and improved dry mouth symptoms
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunwei Wei
Phone
+86-0451-85553099
Email
hydwyw11@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunwei Wei
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Study Director
Facility Information:
Facility Name
First affiliated hospital of Harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunwei Wei
Phone
+86-0451-85553099
Email
hydwyw11@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28911724
Citation
Verburg FA, Hanscheid H, Luster M. Radioactive iodine (RAI) therapy for metastatic differentiated thyroid cancer. Best Pract Res Clin Endocrinol Metab. 2017 Jun;31(3):279-290. doi: 10.1016/j.beem.2017.04.010. Epub 2017 May 9.
Results Reference
background
PubMed Identifier
22027478
Citation
Ciorba MA, Riehl TE, Rao MS, Moon C, Ee X, Nava GM, Walker MR, Marinshaw JM, Stappenbeck TS, Stenson WF. Lactobacillus probiotic protects intestinal epithelium from radiation injury in a TLR-2/cyclo-oxygenase-2-dependent manner. Gut. 2012 Jun;61(6):829-38. doi: 10.1136/gutjnl-2011-300367. Epub 2011 Oct 24.
Results Reference
background
PubMed Identifier
29550911
Citation
Linn YH, Thu KK, Win NHH. Effect of Probiotics for the Prevention of Acute Radiation-Induced Diarrhoea Among Cervical Cancer Patients: a Randomized Double-Blind Placebo-Controlled Study. Probiotics Antimicrob Proteins. 2019 Jun;11(2):638-647. doi: 10.1007/s12602-018-9408-9.
Results Reference
background
PubMed Identifier
35350100
Citation
Lin B, Zhao F, Liu Y, Wu X, Feng J, Jin X, Yan W, Guo X, Shi S, Li Z, Liu L, Chen H, Wang H, Wang S, Lu Y, Wei Y. Randomized Clinical Trial: Probiotics Alleviated Oral-Gut Microbiota Dysbiosis and Thyroid Hormone Withdrawal-Related Complications in Thyroid Cancer Patients Before Radioiodine Therapy Following Thyroidectomy. Front Endocrinol (Lausanne). 2022 Mar 8;13:834674. doi: 10.3389/fendo.2022.834674. eCollection 2022.
Results Reference
derived

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the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

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