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Correlation Between Intestinal Microflora Metabolites and Amyotrophic Lateral Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04948346
Enrollment
40
Registered
2021-07-01
Start date
2018-01-31
Completion date
2021-06-01
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

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

Detailed description

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.

Interventions

OTHERdiagnosed with ALS

diagnosed with ALS

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma TMAO levels6 month after inclusion into the studyPlasma TMAO levels in ALS patients and their spouses

Secondary

MeasureTime frameDescription
Change rate of frs-r score6 month after inclusion into the studyChange rate of frs-r score in ALS patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026