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The effect of probiotic in HIV patients

The effect of probiotic supplementation Lactobacillus Rhamnosus (RC-14) and Lactobacillus Reuteri ( GR-1) on increasing the number of CD4 in HIV patients, A double blind randomized clinical trial with a placebo control.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016092228308N1
Enrollment
50
Registered
2016-09-22
Start date
2016-08-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

HIV. Unspecified human immunodeficiency virus [HIV] disease

Interventions

Intervention 1: Zist Takhmir Company probiotic capsules containing ( Lactobacillus Rhamnosus GR-1 and Lactobacil lus Reuteri RC-14 10 ^ 9 colony forming units ), one capsule every 12 hours for 24 we
Treatment - Drugs
Placebo
Zist Takhmir Company probiotic capsules containing ( Lactobacillus Rhamnosus GR-1 and Lactobacil lus Reuteri RC-14 10 ^ 9 colony forming units ), one capsule every 12 hours for 24 weeks.
One Placebo capsule every 12 hours for 4 weeks

Sponsors

Vice chancellor for research Tehran University of Medical Sciences
Lead Sponsor
Zist Takhmir Company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Confirm HIV infection by Western blot analysis; lack of criteria for initiating treatment according to national HIV guideline; no use of probiotic supplements in the past 6 months ; have a consent to conduct research Exclusion criteria:On Highly Active Anti Retroviral Therapy (HAART) regimens; active addiction; opportunistic infection in the past; Liver or Kidney failure; inflammatory bowel disease and other well known Gastrointestinal pathology; active infection and fever; younger than 18 and older than 65 years; have a cancer, pregnancy and breastfeeding; being dependent on alcohol; a history of allergy or sensitivity to the probiotic or lactose intolerance; use of other supplement drugs, and multivitamins; Use of growth hormone, testosterone or anabolic agent during the last 6 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
CD4. Timepoint: At baseline ,three months later, and after 6 months. Method of measurement: Based on the number per microliter by laboratory blood tests.

Secondary

MeasureTime frame
CRP. Timepoint: At baseline ,three months later, and after 6 months. Method of measurement: Based on the number per microliter by laboratory blood tests.;Side effects. Timepoint: every 4 week after intervention. Method of measurement: Based on side effects checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Asadollahi Amin

Tehran University of Medical Science

amiyaneh@gmail.com+98 21 7752 0856

Outcome results

None listed

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