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NCT06279819

Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients

Status unknown NA Last updated 28 February 2024
What this trial tests

NA trial testing gut microbiota-targeted dietary intervention in Hiv in 106 participants. Status unknown.

Timeline
1 March 2024
Primary endpoint
31 December 2024
31 December 2024

Quick facts

Lead sponsorFudan University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment106
Start date1 March 2024
Primary completion31 December 2024
Estimated completion31 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Fudan University

Who can join

18 and older, any sex, with Hiv or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are: * Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease. * Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients. * Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease. Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of gut microbiota-targeted dietary intervention

Trials testing the same drug.

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Other Fudan University trials

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