NCT03095963

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

March 15, 2017

Last Update Submit

March 24, 2017

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (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

    Through study completion, an average of 4 months

Secondary Outcomes (8)

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

    Through study completion, an average of 4 months

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

    Through study completion, an average of 4 months

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

    Through study completion, an average of 4 months

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

    Through study completion, an average of 4 months

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

    Through study completion, an average of 4 months

  • +3 more secondary outcomes

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

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

Other: a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®)Drug: levothyroxin

Levothyroxine

ACTIVE COMPARATOR

The control group took levothyroxine only

Drug: levothyroxin

Interventions

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

Probiotics
levothyroxinDRUG

replacement therapy for hypothyroidism

LevothyroxineProbiotics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29184537DERIVED

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Unit of Endocrinology, Department of Medicine, Endocrinology, Metabolism and Geriatrics, Azienda Ospedaliero-Universitaria of Modena, Modena, Italy

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 30, 2017

Study Start

January 1, 2014

Primary Completion

October 25, 2016

Study Completion

October 25, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03