- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095963
Interaction Between Levothyroxine and Probiotics in Hypothyroid Patients
Effects of Probiotics Assumption on Serum Thyroid Hormone and TSH Levels in Hypothyroid Patients on Levothyroxine Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Consecutive patients on LT4 replacement therapy attending the Endocrinology Unit of Modena (Italy) were screened. According to inclusion and exclusion criteria, eighty participants were enrolled and randomized in study or control group. The random allocation sequence was generated using 'Statistical Package for the Social Sciences' software for Macintosh (SPSS) considering a 1:1 ratio by the statistician of the Unit. Clinicians evaluating and enrolling patients were blinded to the randomization list. The study design provided a monthly visit for a 4 months overall time-frame. Patients assigned to the study group took the probiotic supplement VSL#3® for two months, followed by a two months period of follow-up. Study group patients were taught to assume the probiotic supplement at least two hours after LT4 administration, to dissolve it in a cold beverage and to store it in a refrigerator (2°-8°C) in order to preserve bacteria load. The study design was single-blind since only the clinician was aware of the allocation. The VSL#3® administration was provided by nurses. Participants were invited to return all used and unused sachets to count the number of opened sachets per the number of treatment days.
All patients underwent five visits (baseline, visit 1, 2, 3 and 4) in which anthropometrical evaluation (weight and height) and hormonal function assessment were performed. A blood sample was taken in the morning at each visit, on empty stomach and before LT4 ingestion. In occurrence of hormonal alteration, LT4 daily dose was adjusted according to clinical guidelines. At baseline, visit 2 and visit 4, patients underwent clinical examination with heart rate and blood pressure evaluation. During each visit, the following data were collected: probiotic assumption, sex, age, hypothyroidism aetiology, LT4 formulation dose and brand, body mass index (BMI), body surface area (BSA), systolic blood pressure, diastolic blood pressure, heart rate, TSH, fT4, fT3 and any possible LT4 posology adjustment. All the clinical data have been further databased.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary hypothyroidism on LT4 replacement therapy
- TSH, fT3 and fT4 in the normal range
- stable LT4 dosage during the previous six months before enrolment
- Caucasian ethnicity
Exclusion Criteria:
- total thyroidectomy for thyroid carcinoma
- high fiber diet
- intestinal malabsorption (e.g. bariatric surgery, inflammatory bowel diseases, coeliac disease)
- ongoing therapies interfering with LT4 absorption and/or metabolism (i.e. aluminium-containing antacids, sucralfate, proton pump inhibitors, calcium carbonate, raloxifene, bile acids sequestrants and ferrous sulfate)
- antibiotics treatment in the previous six months before enrolment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Probiotics
The study group took a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®) in addition to levothyroxine
|
Patients assigned to the study group took the probiotic supplement VSL#3® for two months, in addition to levothyroxine
replacement therapy for hypothyroidism
|
Active Comparator: Levothyroxine
The control group took levothyroxine only
|
replacement therapy for hypothyroidism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
differences in thyroid-stimulating hormone (TSH) serum levels comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of thyroid-stimulating hormone (TSH) - unit of measure: microIU/mL, normal range: 0.35-4.94
|
Through study completion, an average of 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of total cholesterol (CH) - unit of measure: mg/dL, normal range: <200
|
Through study completion, an average of 4 months
|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of sex hormone-binding globulin (SHBG) - unit of measure: nmol/L, normal range: males 13.5-71.4,
females 19.8-155.2
|
Through study completion, an average of 4 months
|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of ferritin - unit of measure: ng/mL, normal range: 25-400
|
Through study completion, an average of 4 months
|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of creatine phosphokinase (CPK) - unit of measure: U/L, normal range: 10-71
|
Through study completion, an average of 4 months
|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of myoglobin - unit of measure: ng/mL, normal range: 15-106
|
Through study completion, an average of 4 months
|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of osteocalcin - unit of measure: ng/mL, normal range: 4.6-65.4
|
Through study completion, an average of 4 months
|
differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of angiotensin-converting enzyme (ACE) - unit of measure: U/L, normal range: 8-52
|
Through study completion, an average of 4 months
|
differences in thyroid hormones by biochemical assays comparing study group and controls
Time Frame: Through study completion, an average of 4 months
|
measurement of serum levels of free triiodothyronine (fT3) - unit of measure: pg/mL, normal range: 1.7-3.7;
measurement of serum levels of free thyroxine (fT4) - unit of measure: pg/mL, normal range: 7-15
|
Through study completion, an average of 4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Levothyroxine and Probiotics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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