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Intestinal bacteria transplantation promotes immune reconstitution in HIV patients with poor immune reconstitution: a prospective, multicenter, controlled clinical study

Intestinal bacteria transplantation promotes immune reconstitution in HIV patients with poor immune reconstitution: a prospective, multicenter, controlled clinical study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090820
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

HIV

Interventions

Intestinal bacteria transplantation group :Intestinal bacteria transplantation
blank control group:Blank treatment
probiotics:probiotics capsule

Sponsors

The Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: Age =18 years old, male or female 2: Line with the People's Republic of China health industry standard (WS293-2008) - "AIDS and HIV infection diagnostic criteria", confirmed as HIV-1 infection 3: After 2 years of ART treatment, ART regimen is not limited, HIV viral load <50 copies /ml, CD4+T cell count < 350 /uL for 2 consecutive times, defined as poor immune reconstitution

Exclusion criteria

Exclusion criteria: 1: Have participated in HIV vaccine clinical trials or other drug trials within the last three months 2: In the past 1 month, there is evidence of fever, acute infection or history of antibiotic use; 3: Evidence of drug addiction (including excessive alcohol consumption) in the year prior to joining the trial 4: A history of serious mental illness, especially depression 5: Pregnant women or breastfeeding women 6: Intestinal obstruction, intestinal perforation or gastrointestinal bleeding 7: Important organ failure 8: Have a history of severe epilepsy or are currently receiving sedatives 9: Evidence of immune-mediated disease, or other malignant disease, or other conditions of the patient that the investigator deems unsuitable for participation in the study 10: The investigator judged that the patient was unable to complete the scheduled follow-up (e.g., weak health, poor compliance, etc.) 11: Inability or unwillingness to provide informed consent or comply with trial requirements

Design outcomes

Primary

MeasureTime frame
CD4 lymphocyte count;

Secondary

MeasureTime frame
Intestinal flora changes;

Countries

China

Contacts

Public ContactJinyu Xia

The Fifth Affiliated Hospital of Sun Yat-sen University

313108094@qq.com+86 138 2307 8064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026