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Status unknownNCT05196594AMIATUpdated Jan 19, 2022

Analysis of the Instestinal Microbiome of Patients With Transthyretin Amyloidosis

An observational study in Amyloidosis, Hereditary, Transthyretin-Related and Microbial Colonization, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by University of Sao Paulo General Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

Amyloidosis is a serious systemic disease. Cardiac involvement has a great impact on prognosis and can occur in its three main forms: acquired monoclonal light chain, hereditary transthyretinal and senile form. The physiopathogenesis basically results from the deposition of an abnormal protein (amyloid) with toxic properties to the myocyte. The scope of this study will be a hereditary transthyretinal amyloidosis (hATTR). It is known that amyloidotic cardiomyopathy due to transthyretin deposit is an underdiagnosed cause of heart failure in adults, being an important differential diagnosis of diseases that manifest with increased myocardial thickness, such as hypertrophic cardiomyopathy or myocardial hypertrophy that accompanies the different degrees of aortic valve stenosis.

The human gut microbiota is immensely diverse. It is estimated at around 100 trillion microorganisms, including bacteria, fungi and viruses. The microbiota of each individual is unique and determined by genetic factors such as age, type of delivery, use of antibiotics and diet. Recent data point to the hypothesis that the resilience of the intestinal microbiota plays a role in the process of disease development and health restoration.

Read the detailed description

The scope of this study will be hereditary transthyretinal amyloidosis (hATTR). It is known that amyloidotic cardiomyopathy due to transthyretin deposition is an underdiagnosed cause of heart failure in adults, being an important differential diagnosis of diseases that manifest with increased myocardial thickness, such as hypertrophic cardiomyopathy or the myocardial hypertrophy that accompanies the different degrees of aortic valve stenosis.

The transthyretin protein is synthesized and secreted into the bloodstream mainly by the liver. Other organic sites also produce and secrete it in smaller amounts. The choroid plexus produces and releases transthyretin in the cerebrospinal fluid, while the cells of the pigmented retinal epithelium are also capable of producing and releasing it into the vitreous body. Formerly called prealbumin, transthyretin is composed of four monomers that circulate in tetrameric form. It has the main function of carrying retinol and thyroxine . The degeneration of the protein tetramer and its deposition in the different fluids in which it is present determine the clinical dysfunction and the specific phenotypes of ATTR.

The gene that decodes the transthyretin protein (TTR) is located on chromosome 18. In ATTRh, alterations in the amino acid sequence destabilize the tetramer. It is conventional to designate genetic variants by the initials of the normal amino acid followed by their position in the gene and the amino acid that replaces it. Thus, the Val30Met variant translates that methionine is in place of valine at position 30.

The cuminal event of the pathophysiology is the degeneration of the tetramer into monomers that, once denatured, infiltrate several structures in the form of amyloid fibrils. In the myocardium, this process causes rigidity and varying degrees of dysfunction secondary to the intrinsic toxicity of these fibrils and to the occupation of the interstitium.

Clinically, ATTR can manifest itself as an autonomic polyneuropathy or as a cardiomyopathy. Eventually, the phenotype can involve both manifestations . Changes in the cardiac conduction system and arrhythmias usually precede heart failure by years.

Within the spectrum of alterations resulting from autonomic neuropathy, different degrees of intestinal transit disorders may occur, manifested as diarrhea, constipation, nausea or even asymptomatically.

Digestive symptoms are one of the most relevant and early clinical aspects of amyloidotic polyneuropathy, due to their frequency and intensity and the negative influence they have on the well-being of patients. Important changes in gastrointestinal motility are the main justification for these manifestations, being an expression of neurovegetative dysautonomia. Occurs: diarrhea, constipation, nausea, vomiting and feeling of gastric fullness.

Weight loss is a progressive and important feature, usually early and constant. It may be linked to gastrointestinal manifestations, malabsorption or renal and digestive protein losses. It is one of the worst prognosis manifestations of the disease.

The human gut microbiota is immensely diverse. It is estimated at around 100 trillion microorganisms, including bacteria, fungi and viruses. The microbiota of each individual is unique and determined both by genetic factors and by age, type of delivery, use of antibiotics and diet. There is evidence that such microorganisms play a fundamental role in food digestion, vitamin synthesis, production of short-chain fatty acids, modulation of the immune system and protection against infections. In healthy individuals, bacteria of the phyla Firmicutes and Bacterioidetes usually predominate, followed by Verrucromicrobia and Actinobacteria. However, the relative proportions and species present can vary widely between individuals and fluctuate over time, particularly during the early stages of life and during the evolution of certain diseases. Recent data point to the hypothesis that the resilience of the intestinal microbiota plays a role in the process of disease development and health restoration.

02

Conditions studied

  • Amyloidosis, Hereditary, Transthyretin-Related
  • Microbial Colonization

Keywords

  • gut microbiome
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In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 60 is below the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Three groups of patients: a group affected by transthyretinal amyloidosis with cardiac involvement, another group affected by transthyretinal amyloidosis but without cardiac involvement, and a third healthy control group who live and share eating habits similar to those of the patients.

Inclusion criteria

  • Diagnosis of transthyretin amyloidosis documented by pathogenic transthyretin mutation;
  • evidence of cardiac involvement on echocardiogram or MRI; amyloid deposit confirmed by Congo red staining or presence of myocardial scintigraphy with grade 2 or 3 uptake (with distant monoclonal gammopathy of uncertain significance (MGUS);
  • in the presence of MGUS it is necessary to confirm the TTR protein in the tissue by immunohistochemistry or mass spectrometry. Non-consanguineous living with patients;
  • Sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Inflammatory bowel disease or persistent diarrhea for more than two weeks;
  • Use of antibiotics and/or prebiotic or probiotic supplements in the two months prior to collection;
  • Concurrent participation in other clinical studies.
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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Affected group by transthyretinal amyloidosis with cardiac involvement

    collection of stools

    Diagnostic Test: collection of stools for genetic analysis

  • Affected group by transthyretinal amyloidosis without cardiac involvement

    collection of stools

    Diagnostic Test: collection of stools for genetic analysis

  • healthy control group

    collection of stools

    Diagnostic Test: collection of stools for genetic analysis

Interventions

  • Diagnostic testcollection of stools for genetic analysis

    Intestinal microbiome analysis

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What researchers measure

Primary outcomes

  1. Gut Microbiome

    Gene number (diversity index)

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • University of Sao Paulo Medical School - The Heart Institute
    Sao Paulo, 05403-000, Brazil
    • Fabio Fernandes, MD, PhD · Contact · fabio.fernandes@incor.usp.br · +551126615057
    • Aristoteles C. Neto, Bachelor · Contact · aristotelesalencar@gmail.com · +5511960993262
    • Fabio Fernandes, MD, PhD · Principal investigator
    • Aristoteles C. Neto, B.S. · Sub investigator
    • Caio Cafezeiro, B.S. · Sub investigator
    • Joao H. Rissato, B.S. · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05196594
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Sponsor
First posted
Jan 19, 2022
Start date
May 1, 2021
Primary completion
May 2023 (estimated)
Completion
May 31, 2023 (estimated)
Last update
Jan 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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