The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258556

Enrollment

150

Registered

2010-12-13

Start date

2010-06-30

Completion date

Unknown

Last updated

2010-12-13

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

Conditions

Bacterial Vaginosis

Brief summary

Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.

Interventions

DIETARY_SUPPLEMENTYogurt supplemented with L. rhamnosus fiti

200 ml of L. rhamnosus fiti at 10\*9 cfu/ml daily for 30 days.

DIETARY_SUPPLEMENTYogurt not supplemented with a probiotic strain.

200 ml yoghurt without L. rhamnosus fiti daily for 30 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Confirmed HIV infection; * Being treated with anti-retroviral medication for \> 6 months.

Exclusion criteria

* Pregnancy; * Hypersensitive to fermented milk; * Intolerant for lactose; * Complaints of bacterial vaginosis requiring treatment

Design outcomes

Primary

Measure	Time frame
Vaginal microbiota of HIV patients.	30 days

Secondary

Measure	Time frame
Bacterial vaginosis.	30 days

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026