Clinical trial NCT04948346: Correlation Between Intestinal Microflora Metabolites and Amyotrophic Lateral Sclerosis
Official title: Relationship Between N-trimethylamine Oxide, a Metabolite of Intestinal Flora, and Pathogenesis and Progression of Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with Sporadic ALS

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma TMAO levels
timeFrame: 6 month after inclusion into the study
Secondary outcomes:
measure: Change rate of frs-r score
timeFrame: 6 month after inclusion into the study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Lu Chen
role: PRINCIPAL_INVESTIGATOR
References: