Evaluation of the possible effects in the intestine of two different pharmaceutical forms of L - Thyroxine in patients with primary acquired hypothyroidism

Phase 1

• Conditions: Primary acquired hypothyroidism; MedDRA version: 20.0Level: LLTClassification code 10000559Term: Acquired hypothyroidismSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-001248-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Children with primary acquired hypothyroidism that require Levothyroxine therapy (naïve patients, < 18 years)
2. Informed consent from parents and patient

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age < 3 years
2. Patients with secondary hypothiroidism, euthyroid sick syndrome or thyroid ormone resistant
3. Patients with celiac diasease, type I diabetes or other known autoimmune diseases
4. Patients with genetic diseases or syndromes, such as Down, Williams-Beuren, Turner
5. Assumption of antibiotics, probiotics, prebiotics, or other medications that could affect the gut microbiota in the month before the beginning of the study
6. Gastrointestinal infectious diaseases in the month before the beginning of the study
7. Hypersensitivity to levothyroxine or any of the ingredients contained in the two pharmaceutical formulations
8. Untreated adrenal insufficiency, untreated pituitary insufficiency and untreated thyrotoxicosis.
9. Patients with cardiovascular disease
10. Patients who show with impaired pancreatic function measured using the assay in faecal fat (steatocrit) at the screeening visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effect of two different pharmaceutical forms of L-Thyroxine on the gut in terms of inflammatory parameters, gut absorption;Secondary Objective: - Evaluate the effect of two different pharmaceutical forms of L-Thyroxine on the gut in terms of modification of gut microbiota<br>- Evaluate the effect of the disease (congenital Hypothyroidism) on the gut in terms of modification of gut microbiota, inflammatory parameters, gut absorption<br>- Evaluate the incidence of celiac disease in hypothyroid patients;Primary end point(s): Calculate the difference in gut inflammation parameters (calprotectin, osteoprotegerin, S100-A12 protein) and gut absorption parameters among the two groups of patients at T6-T0 and T12-T6;Timepoint(s) of evaluation of this end point: 6-12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Qualitative and quantitative (percentage) characterization of gut microbiota before the initiation of the therapy (T0); Difference in gut microbiota among hypothyroid patients (t0) and healthy patients (data from Human Microbiome Project); Estimate the incidence of positive patients to deamidated AGA T6, T12 e a T24 (follow-up); Evaluate gut inflammation (calprotectin, Osteoprotegerin and S100-A12 protein) and gut absorption (Steatocrit) parameters before the initiation of the therapy (T0); Calculate the difference in Shannon Index<br>(index of diversity), Chao I (Species richness estimator), percentage of different species (OTU, operational taxonomic unit) among the two groups of patients at T6-T0 and T12-T6;Timepoint(s) of evaluation of this end point: BASELINE; BASELINE; BASELINE; BASELINE; 6-12 months