Bacterial VaginosisPhase 2/3NCT01258556
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
A Phase 2/3 study testing Yogurt supplemented with L. rhamnosus fiti and Yogurt not supplemented with a probiotic strain. in people with Bacterial Vaginosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Yogurt supplemented with L. rhamnosus fiti and Yogurt not supplemented with a probiotic strain.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTanzania
- Study dates
- Jun 2010to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV infection;
- Being treated with anti-retroviral medication for > 6 months.
Who cannot join
- Pregnancy;
- Hypersensitive to fermented milk;
- Intolerant for lactose;
- Complaints of bacterial vaginosis requiring treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bacterial Vaginosis
- Being tested
- Yogurt supplemented with L. rhamnosus fiti, Yogurt not supplemented with a probiotic strain.
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt supplemented with L. rhamnosus fitiDietary supplement
200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.
Yogurt not supplemented with a probiotic strain.Dietary supplement
200 ml yoghurt without L. rhamnosus fiti daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic yogurt | Experimental | Not described Receives: Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti |
| Placebo yogurt. | Placebo comparator | Not described Receives: Dietary Supplement: Yogurt not supplemented with a probiotic strain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal microbiota of HIV patients.
Measured: 30 days
Secondary outcomes (1)
Bacterial vaginosis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Investigators
- Nicodemus Butamanya, MD, Principal investigator, Sekou-Toure Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258556
- Sponsor's protocol ID
- 919
- Status last verified
- Dec 2010
- First submitted
- 10 Dec 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01258556
- Acronym / sponsor ID
- 919
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic yogurt | Experimental | Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti |
| Placebo yogurt. | Placebo comparator | Dietary Supplement: Yogurt not supplemented with a probiotic strain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed HIV infection;
- Being treated with anti-retroviral medication for > 6 months.
Key exclusion criteria (4 listed)
- Pregnancy;
- Hypersensitive to fermented milk;
- Intolerant for lactose;
- Complaints of bacterial vaginosis requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt supplemented with L. rhamnosus fiti200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days. | Dietary supplement | Probiotic yogurt |
| Yogurt not supplemented with a probiotic strain.200 ml yoghurt without L. rhamnosus fiti daily for 30 days. | Dietary supplement | Placebo yogurt. |
Primary outcome
Vaginal microbiota of HIV patients.
Time frame: 30 days
1 secondary outcome
Bacterial vaginosis.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2010.
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicodemus Butamanya, MD principal investigator
Sekou-Toure Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Yogurt supplemented with L. rhamnosus fiti and Yogurt not supplemented with a probiotic strain. in people with Bacterial Vaginosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal microbiota of HIV patients. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2010.