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Interaction Between Levothyroxine and Probiotics in Hypothyroid Patients

NCT03095963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-03-30

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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

DRUG

levothyroxin

replacement therapy for hypothyroidism

Sponsors & Collaborators

  • Azienda USL Modena

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2016-10-25
Completion
2016-10-25

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095963 on ClinicalTrials.gov