Correlation Between Intestinal Microflora Metabolites and Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948346
• Other study ID #: M2017358
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• ? 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; ? The patients with dementia or mental disorder could not cooperate with the researchers; ? Patients with severe heart, liver, kidney and other severe concomitant diseases; ? Patients with gastrointestinal diseases or gastrointestinal surgery may affect gastrointestinal absorption; ? The patients who were treated with antibiotics, L-carnitine and intestinal flora regulation in recent 3 months; ? Breast feeding or pregnancy; ? Patients with dysphagia, inability to eat normal food, or indwelling gastric tube or gastrostomy for enteral nutrition.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• diagnosed with ALS
diagnosed with ALS

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma TMAO levels	Plasma TMAO levels in ALS patients and their spouses	6 month after inclusion into the study
Secondary	Change rate of frs-r score	Change rate of frs-r score in ALS patients	6 month after inclusion into the study