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Completed

NCT Number: NCT02038504

Investigating the Role of EN in NTIS Among Fistula Patients

The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

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Key information

Conditions

Gastrointestinal Fistula Digestive System Diseases Digestive System Fistula Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Surgery, Jinling Hospital

Nanjing, Jiangsu, 210000, China

About this study

Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of gastrointestinal fistula
  • Clinical diagnosis of nonthyroidal illness syndrome
  • Using enteral nutrition for fistula management

Exclusion criteria

  • patients who were prescribed drug which may affect thyroid function before or in our study
  • patients who were diagnosed as primary thyroid disease

Treatment and study plan

Primary outcomes

  1. Thyroid function

    Time frame: Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.

    Thyroid function assessment includes level of free triiodothyronine,total triiodothyronine,free thyroxin,total thyroxin,thyroid stimulating hormone,thyroid stimulating hormone index,and standard thyroid stimulating hormone index

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients

Acronym: EN;NTIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2014
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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