Correlation Between Intestinal Microflora Metabolites and Amyotrophic Lateral Sclerosis

NCT04948346 | Completed DMC

• 1 other identifier: M2017358
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Plasma TMAO levels

  Plasma TMAO levels in ALS patients and their spouses

  6 month after inclusion into the study

Secondary Outcomes (1)

• Change rate of frs-r score

  6 month after inclusion into the study

Study Arms (2)

patient with ALS

Other: diagnosed with ALS

patient'spouse(without ALS)

Interventions

diagnosed with ALS OTHER

diagnosed with ALS

patient with ALS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with Sporadic ALS

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lu Chen

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 1, 2021
• Study Start: January 31, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)