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HypothyroidismNCT03095963

Interaction Between Levothyroxine and Probiotics in Hypothyroid Patients

A study testing a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®) and levothyroxin in people with Hypothyroidism, run by Azienda USL Modena.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective, randomized, single-blind, controlled, investigator-started clinical trial was carried out. Patients with primary hypothyroidism were randomly assigned to the study (VSL#3®+ LT4) and the control group (LT4). A two months treatment phase was followed by two months of follow-up. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypothyroidism
What is being tested?
a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®) and levothyroxin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Jan 2014to 25 Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Effects of Probiotics Assumption on Serum Thyroid Hormone and TSH Levels in Hypothyroid Patients on Levothyroxine Treatment

A prospective, randomized, single-blind, controlled, investigator-started clinical trial was carried out. Patients with primary hypothyroidism were randomly assigned to the study (VSL#3®+ LT4) and the control group (LT4). A two months treatment phase was followed by two months of follow-up. Clinical examination, blood tests for thyroid function and for peripheral tissue markers of thyroid hormones effect were performed monthly for 4 months. LT4 dose adjustments were performed during the study when necessary.

Read the 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.

Conditions
Hypothyroidism
Being tested
a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®), levothyroxin
Medical subject headings
Hypothyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®)Other

    Patients assigned to the study group took the probiotic supplement VSL#3® for two months, in addition to levothyroxine

  • levothyroxinDrug

    replacement therapy for hypothyroidism

Study groups in NCT03095963
Study groupRoleWhat they receive
ProbioticsActive comparatorThe study group took a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®) in addition to levothyroxine
Receives: Other: a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®); Drug: levothyroxin
LevothyroxineActive comparatorThe control group took levothyroxine only
Receives: Drug: levothyroxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. differences in thyroid-stimulating hormone (TSH) serum levels comparing study group and controls

    measurement of serum levels of thyroid-stimulating hormone (TSH) - unit of measure: microIU/mL, normal range: 0.35-4.94

    Measured: Through study completion, an average of 4 months

Secondary outcomes (8)

  1. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    measurement of serum levels of total cholesterol (CH) - unit of measure: mg/dL, normal range: <200

    Measured: Through study completion, an average of 4 months

  2. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    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

    Measured: Through study completion, an average of 4 months

  3. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    measurement of serum levels of ferritin - unit of measure: ng/mL, normal range: 25-400

    Measured: Through study completion, an average of 4 months

  4. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    measurement of serum levels of creatine phosphokinase (CPK) - unit of measure: U/L, normal range: 10-71

    Measured: Through study completion, an average of 4 months

  5. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    measurement of serum levels of myoglobin - unit of measure: ng/mL, normal range: 15-106

    Measured: Through study completion, an average of 4 months

  6. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    measurement of serum levels of osteocalcin - unit of measure: ng/mL, normal range: 4.6-65.4

    Measured: Through study completion, an average of 4 months

  7. differences in peripheral tissue markers of thyroid hormones by biochemical assays comparing study group and controls

    measurement of serum levels of angiotensin-converting enzyme (ACE) - unit of measure: U/L, normal range: 8-52

    Measured: Through study completion, an average of 4 months

  8. differences in thyroid hormones by biochemical assays comparing study group and controls

    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

    Measured: Through study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start1 Jan 2014
  3. Primary completion25 Oct 2016
  4. Study completion25 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03095963
Sponsor's protocol ID
Levothyroxine and Probiotics
Status last verified
Mar 2017
First submitted
15 Mar 2017
Last updated
30 Mar 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Spaggiari G, Brigante G, De Vincentis S, Cattini U, Roli L, De Santis MC, Baraldi E, Tagliavini S, Varani M, Trenti T, Rochira V, Simoni M, Santi D. Probiotics Ingestion Does Not Directly Affect Thyroid Hormonal Parameters in Hypothyroid Patients on Levothyroxine Treatment. Front Endocrinol (Lausanne). 2017 Nov 14;8:316. doi: 10.3389/fendo.2017.00316. eCollection 2017.

    PubMed 29184537

Questions about this trial

What is this clinical trial studying?

A study testing a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®) and levothyroxin in people with Hypothyroidism, run by Azienda USL Modena.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

differences in thyroid-stimulating hormone (TSH) serum levels comparing study group and controls (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03095963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.

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