이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Taurine Supplementation in Adolescents With Post-COVID Condition (TaurineLCPeds)

2026년 8월 11일 업데이트: University of Alberta

An Open-Label Study of Taurine Supplementation in Adolescents With Post-COVID Condition: Quantifying Taurine Plasma Levels and Evaluating Clinical and Biological Outcomes

The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19 (PASC), has emerged as a complex multisystemic condition and challenging public health issue.

Contrary to initial perceptions, pediatric Long COVID is a significant health concern, with studies suggesting its prevalence ranges from 10% to 25% following infection. Research in the pediatric population has largely been limited to observational studies based on self-reported symptoms or large electronic healthcare datasets. The long-term outcomes and predictors of LC in children remain poorly described, highlighting an urgent need for further mechanistic research to characterize this complex condition. While acute COVID-19 symptoms are often milder in children relative to adults, some go on to develop a range of chronic physical, immunological, psychological, and neurological symptoms persisting for weeks to years after initial infection. The most commonly reported symptoms are similar to those seen in adults and include debilitating fatigue, respiratory distress, headaches, gastrointestinal symptoms, and neurocognitive impairment. Other frequently reported symptoms include muscle pain, sleep disturbances, olfactory and gustatory disturbances, exercise intolerance, and heart palpitations/cardiovascular symptoms. These symptoms can be new, or they may persist or fluctuate from the initial illness. Additionally, many children with LC experience psychological symptoms such as anxiety, depression, and mood disturbances, which are thought to be exacerbated by experiencing prolonged illness and subsequent lifestyle disruptions.

Currently, effective treatments for LC remain elusive, leaving patients to contend with persistent symptoms that significantly impair their quality of life. For children and adolescents, these issues can profoundly impact their daily activities, academic performance, and social interactions/friendships. Symptoms like debilitating fatigue, cognitive impairment, and mood disturbances are especially disruptive by interfering with memory, energy levels, and overall development, often leading to school absenteeism, social withdrawal, and psychological distress. Therefore, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.

연구 개요

상태

아직 모집하지 않음

개입 / 치료

상세 설명

Purpose: The primary objective is to quantify the increase in plasma taurine concentrations in adolescents following three months of taurine supplementation and evaluate the efficacy and safety of taurine supplementation in treating and managing prolonged symptoms related to LC.

Hypothesis: Increasing taurine levels in the body through treatment with taurine supplements will have a beneficial effect on Long COVID symptoms particularly neurocognitive-associated symptoms and fatigue.

Justification: Previous studies have suggested a correlation between low plasma taurine levels and symptoms associated with Long COVID. The decreasing trajectory of taurine levels observed in long COVID could partly explain the fatigue, as taurine plays multiple roles in skeletal muscle function, the central nervous system, and energy metabolism. Furthermore, in various clinical and preclinical studies, including antioxidant, anti-aging, cytoprotective, and cardioprotective effects, taurine has demonstrated various therapeutic activities. Taurine also has a role in neuromodulation and the treatment of other central nervous system disorders, including depression. These findings suggest that taurine may be important in addressing the persistent symptoms and adverse outcomes in LC patients.

Given the robust association between taurine levels and symptoms and adverse outcomes of LC and the safety profile, there is a strong biological and clinical rationale for investigating taurine supplementation. There is a lack of effective treatments for LC in adolescents, and exploring taurine supplementation as a novel therapeutic approach is justified and holds the potential to significantly improve the lives of affected individuals with an excellent safety profile.

Objectives: The overall trial objectives are to to quantify the increase in plasma taurine concentrations in adolescents following three months of taurine supplementation and evaluate the efficacy and safety of taurine supplementation in treating and managing prolonged symptoms related to LC.

연구 유형

중재적

등록 (추정된)

30

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Subjects must be between 10 and 17 years of age at the time of study enrollment
  2. Positive COVID-19 test by nasopharyngeal swab RT-PCR test, antibody or antigen tests at least 3 months prior to trial; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019, and at least 3 months prior to trial enrollment.
  3. If participants have treatable symptoms, they should have had a stable regimen of treatment prior to entering the study (i.e. started treatment for at least 4 weeks).
  4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive testing or the date of first symptoms.
  5. Lingering symptoms from COVID-19 present at the time of trial enrollment.
  6. Individuals of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use at least one highly effective method of contraception while on study treatment. Highly effective methods of contraception must be discussed and approved by the overseeing Investigator.
  7. Medication(s) only available through a prescription for the purposes of treating fatigue or cognitive function have been discontinued for four weeks prior to randomization.
  8. Participants must be able to assent to their participation in the study and be both willing and able to comply with study requirements.
  9. Parents/caregivers/guardians must be able to provide informed consent for participation.
  10. Participants must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc.)

Exclusion Criteria:

  1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19.
  2. Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital.
  3. Contraindications to the study intervention.
  4. Currently already on the study intervention (Participants would be eligible if they stopped taking Taurine for a minimum of 4 weeks prior to enrollment).
  5. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted).
  6. Currently pregnant or breastfeeding.
  7. The participant is currently enrolled in another research trial to treat neurocognitive symptoms in LC.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Taurine Intervention
Participants will receive weight-based dosing of taurine capsules administered PO twice daily.
타우린은 신체에서 흔히 발견되는 자연 발생 아미노술폰산입니다. 이는 천연 건강 제품/보충제로 판매되며 신체에서 중요한 역할을 합니다.
다른 이름들:
  • 2-Aminoethanesulfonic acid

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Change in Plasma Taurine Levels from Baseline to Three Months
기간: Three months
This study will measure the plasma taurine levels at baseline and following three months of taurine supplementation.
Three months

2차 결과 측정

결과 측정
측정값 설명
기간
Fatigue
기간: Three months
This study will target detection of a change in the PROMIS Pediatric Fatigue Short Form from baseline to three months
Three months
Cognitive Function
기간: Three months
This study will target detection of a change in the PROMIS Pediatric Cognitive Function Short Form from baseline to three months
Three months
Cardiovascular
기간: Three months
This study will target detection of a change in heart rate and heart rate variability from baseline to three months
Three months
Core Outcome Symptoms
기간: Three months
Tracking of symptom trajectory from baseline to three months
Three months
Health Related Quality of Life
기간: Three months
Measurement of change in quality of life using the EQ-5D-Y-3L assessment tool.
Three months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Lawrence Richer, MD, MSc, University of Alberta

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 30일

기본 완료 (추정된)

2028년 3월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 26일

QC 기준을 충족하는 최초 제출

2026년 6월 26일

처음 게시됨 (실제)

2026년 7월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 11일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다