NCT01258556

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

1 month

First QC Date

December 10, 2010

Last Update Submit

December 10, 2010

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Vaginal microbiota of HIV patients.

    30 days

Secondary Outcomes (1)

  • Bacterial vaginosis.

    30 days

Study Arms (2)

Probiotic yogurt

EXPERIMENTAL
Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti

Placebo yogurt.

PLACEBO COMPARATOR
Dietary Supplement: Yogurt not supplemented with a probiotic strain.

Interventions

Yogurt supplemented with L. rhamnosus fitiDIETARY_SUPPLEMENT

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

Probiotic yogurt
Yogurt not supplemented with a probiotic strain.DIETARY_SUPPLEMENT

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

Placebo yogurt.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sekou-Toure Regional Hospital

Mwanza, Tanzania

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nicodemus Butamanya, MD

    Sekou-Toure Regional Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 13, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations

TA(1)