Interaction Between Levothyroxine and Probiotics in Hypothyroid Patients

NCT ID: NCT03095963

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2016-10-25

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Probiotics

The study group took a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®) in addition to levothyroxine

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

levothyroxin

Intervention Type: DRUG

replacement therapy for hypothyroidism

Levothyroxine

The control group took levothyroxine only

Group Type: ACTIVE_COMPARATOR

levothyroxin

Intervention Type: DRUG

replacement therapy for hypothyroidism

Interventions

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

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

Intervention Type: OTHER

levothyroxin

replacement therapy for hypothyroidism

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Modena

OTHER

Sponsor Role: lead

Responsible Party

Manuela Simoni

Director of Unit of Endocrinology, Department of Medicine, Endocrinology, Metabolism and Geriatrics, Azienda Ospedaliero-Universitaria of Modena, Modena, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 29184537 (View on PubMed)

Other Identifiers

Levothyroxine and Probiotics

Identifier Type: -

Identifier Source: org_study_id