the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

NCT03574051 | Unknown Early Phase 1

• 1 other identifier: Yunwei Wei 2018 -05-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Keywords

oral microbiota; 16S rRNA gene; thyroid cancer; iodine 131 treatment; fecal microbiota; radiotherapy

Outcome Measures

Primary Outcomes (1)

• The number of patients with improved side effects

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

  4 weeks

Study Arms (1)

Probiotic

EXPERIMENTAL

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

Drug: Probiotic

Interventions

Probiotic DRUG

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

Also known as: Complex-probiotic-preparation

Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 28911724 BACKGROUND

• 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.

  PMID: 22027478 BACKGROUND

• 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.

  PMID: 29550911 BACKGROUND

• 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.

  PMID: 35350100 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yunwei Wei

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Yunwei Wei

CONTACT

+86-0451-85553099; hydwyw11@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2022
• Last Updated: July 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)