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OpenTrials
Completed

NCT Number: NCT04948346

Correlation Between Intestinal Microflora Metabolites and Amyotrophic Lateral Sclerosis

To verify the correlation between TMAO level and the pathogenesis and progression of ALS

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Key information

About this study

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with rapid progression, poor prognosis and unknown etiology. At present, there is no effective treatment. In recent years, with the deepening of the research on the interaction between intestinal flora and human health, many studies have found that intestinal flora is closely related to neurodegenerative diseases. In the field of neuroscience, there are more and more researches on the relationship between TMAO and its precursors (L-carnitine, etc.) and neurodegenerative diseases. Although there is no direct study on the relationship between TMAO and ALS, the relevant experiments suggest that intestinal flora, TMAO and its precursors (L-carnitine, etc.) may be involved in the pathogenesis and progression of ALS. The purpose of this study is to verify the important role of TMAO, a metabolite of intestinal flora, in ALS through human studies and animal model studies, and to obtain direct evidence that TMAO participates in the disease process of ALS.

Who can participate

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

Inclusion criteria

  • ① ALS patients in outpatient or ward voluntarily participated in the study and signed informed consent by themselves or their authorized family members; ② At the time of enrollment, the diagnostic grade of ALS patients met the criteria of the World Federation of Neurology (WFN) revised in 1998; ③ They were 18-75 years old; ④ Antibiotics, L-carnitine and intestinal flora regulation were not used within 3 months; ⑤ Can eat normally.

Exclusion criteria

  • ① electromyography detection found motor nerve block, sensory nerve conduction abnormalities, or imaging examination (CT or MRI) found lesions that could explain the clinical manifestations of patients, which did not support the diagnosis of ALS; ② The patients with dementia or mental disorder could not cooperate with the researchers; ③ Patients with severe heart, liver, kidney and other severe concomitant diseases; ④ Patients with gastrointestinal diseases or gastrointestinal surgery may affect gastrointestinal absorption; ⑤ The patients who were treated with antibiotics, L-carnitine and intestinal flora regulation in recent 3 months; ⑥ Breast feeding or pregnancy; ⑦ Patients with dysphagia, inability to eat normal food, or indwelling gastric tube or gastrostomy for enteral nutrition.

Treatment and study plan

diagnosed with ALS

Other

diagnosed with ALS

Primary outcomes

  1. Plasma TMAO levels

    Time frame: 6 month after inclusion into the study

    Plasma TMAO levels in ALS patients and their spouses

Secondary outcomes

  1. Change rate of frs-r score

    Time frame: 6 month after inclusion into the study

    Change rate of frs-r score in ALS patients

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Relationship Between N-trimethylamine Oxide, a Metabolite of Intestinal Flora, and Pathogenesis and Progression of Amyotrophic Lateral Sclerosis

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 1, 2021
Registry last updated
Jul 1, 2021

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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