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Effect of probiotics combined with HAART on improving intestinal mucosal barrier and immune inflammation in AIDS patients

Effect of probiotics combined with HAART on improving intestinal mucosal barrier and immune inflammation in AIDS patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053568
Enrollment
Unknown
Registered
2021-11-24
Start date
2021-11-12
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

HIV-infected patients with intestinal disease

Interventions

Control Group:Only ART
Bifidobacterium Group:ART combined with bifidobacteria and Lactobacillus triplex viable tablets
Bacillus Subtilis Group:ART combined with Bacillus subtilis erectile enteric-soluble capsule

Sponsors

Chongqing Public Health Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients who meet the diagnostic criteria of AIDS and are accompanied by diarrhea, abdominal distension, abdominal pain, abdominal belching, constipation, tenesmus and other intestinal-related symptoms; 2. Aged 18-70 years; no gender limit; 3. Have not received probiotics, prebiotics and other treatments recently; 4. Living and eating regularly, the condition is relatively stable; 5. No major comorbidities; 6. Communication is barrier-free and compliance is good; 7. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to the test drug or have serious side effects and cannot tolerate it; 2. Pregnant and lactating patients; 3. Those with severe heart, lung, liver, kidney and other diseases who are not suitable for colonoscopy and intestinal biopsy; 4. Combined with opportunistic infection, inflammatory bowel disease, intestinal Behcet's disease, intestinal tumor, etc.; 5. Participated in other clinical studies recently; 6. Taking drugs that have a significant impact on the intestinal barrier in the past four weeks, such as metformin, sulfonamides, antibiotics, antifungal drugs, etc.; 7. Other factors that may have a significant impact on the study.

Design outcomes

Primary

MeasureTime frame
The expression of tight junction related proteins Claudin-1, Occludin and ZO-1 in intestinal tissue before and after treatment ;

Secondary

MeasureTime frame
Expression of intestinal immune inflammatory factors before and after treatment;Comparison of safety before and after treatment;Plasma midgut mucosal injury/microbial translocation before and after treatment;

Countries

China

Contacts

Public ContactRong Li

Chongqing Public Health Medical Center

lirongcq@163.com+86 13883886491

Outcome results

None listed

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