HIV InfectionsPhase 2/3NCT00536848
The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients
A Phase 2/3 study testing Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 and Metronidazole in people with HIV Infections and Diarrhea, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial summary
The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and prevent and/or cure bacterial vaginosis among HIV patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV Infections, Diarrhea, Bacterial Vaginosis
- What is being tested?
- Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 and Metronidazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteTanzania
- Study dates
- Oct 2007to Aug 2008
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed HIV infection.
- Participant does not meet the criteria for ARV therapy, CD4 count > 200, no clinical stage 3 or 4 [National guidelines, 2005].
- Having an intermediate Nugent score (4-6), or a positive Nugent score (7-10).
Who cannot join
- Pregnancy or lactating.
- Menstruation at time of diagnosis.
- Hypersensitive to metronidazole/warfarin/lithium/disulfiram.
- Not willing to avoid alcohol use during the metronidazole treatment of 10 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotic Supplementation With Lactobacillus GR-1 and RC-14,on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients; a Randomised, Placebo Controlled Trial
The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and prevent and/or cure bacterial vaginosis among HIV patients.
Read the detailed description
Background: Two third of all people infected with HIV live in Sub-Saharan Africa. A region also affected with a great burden of other infectious diseases. Relatively few patients have access to anti-retroviral treatment and many suffer from debilitating diarrhea that causes their immune system to deteriorate. Prevention of infectious diseases among HIV patients is of great importance and makes the immune system deteriorate less rapidly. The track record for probiotics to prevent and alleviate infectious diarrhea is impressive. So, the use of probiotics among HIV patients is a logical step and could be an adjunctive tool for physicians to halt the decline of the CD4 count.
Another important application for the use of probiotics is in the treatment of bacterial vaginosis (BV). BV is a vaginal infection, caused by a group of pathogens, which is extremely common, and estimated to occur in 50% of black African women. In the US, the prevalence is 29%, which again is extremely high. This infection makes a woman more vulnerable to contracting sexually transmitted infections, including HIV. Having BV is also a risk factor to transmit HIV to a partner or a newborn. Conventional antibiotic treatment of BV has a cure rate of 40% among black African women. A recent study shows that combining the probiotic strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 with an antibiotic has a cure rate of 88%.
- Conditions
- HIV Infections, Diarrhea, Bacterial Vaginosis
- Being tested
- Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14, Placebo, Metronidazole
- Keywords
- Probiotics, HIV, AIDS, Diarrhea, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Immune system, Infectious Diseases, Complementary Therapies, Treatment Naive
- Medical subject headings
- HIV Infections, Diarrhea, Vaginosis, Bacterial, Acquired Immunodeficiency Syndrome, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14Dietary supplement
PlaceboDietary supplement
MetronidazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Metronidazole for 10 days, probiotics for 6 months Receives: Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14; Drug: Metronidazole |
| B | Placebo comparator | Metronidazole for 10 days, placebo for 6 months Receives: Dietary Supplement: Placebo; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 count
Measured: assessed at 10 and 25 weeks
Secondary outcomes (4)
Bacterial vaginosis cure rate
Measured: assesed at week 2, 5, 15, 25
Total serum IgE levels
Measured: baseline and at 10 weeks
Serum cytokine levels
Measured: baseline and at 10 weeks
Diarrhea incidence and length of episodes
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- University of Western Ontario, Canada, Erasmus Medical Center, Sekou-Toure Regional Hosipital, Mwanza, Tanzania, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Danone Institute International
- Investigators
- John Changalucha, MSc, Principal investigator, National Institute for Medical Research, Mwanza Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536848
- Sponsor's protocol ID
- MRRC HIV-Probiotics15
- Status last verified
- Jan 2009
- First submitted
- 27 Sep 2007
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hummelen R, Changalucha J, Butamanya NL, Cook A, Habbema JD, Reid G. Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 to prevent or cure bacterial vaginosis among women with HIV. Int J Gynaecol Obstet. 2010 Dec;111(3):245-8. doi: 10.1016/j.ijgo.2010.07.008.
PubMed 20801446
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supplementation With Lactobacillus GR-1 and RC-14,on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients; a Randomised, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00536848
- Acronym / sponsor ID
- MRRC HIV-Probiotics15
- Conditions
- HIV Infections, Diarrhea, Bacterial Vaginosis
- Keywords
- Probiotics, HIV, AIDS, Diarrhea, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Immune system, Infectious Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- University of Western Ontario, Canada, Erasmus Medical Center, Sekou-Toure Regional Hosipital, Mwanza, Tanzania, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Danone Institute International
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 28 Sep 2007 (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.
The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and prevent and/or cure bacterial vaginosis among HIV patients.
Detailed description
Background: Two third of all people infected with HIV live in Sub-Saharan Africa. A region also affected with a great burden of other infectious diseases. Relatively few patients have access to anti-retroviral treatment and many suffer from debilitating diarrhea that causes their immune system to deteriorate. Prevention of infectious diseases among HIV patients is of great importance and makes the immune system deteriorate less rapidly. The track record for probiotics to prevent and alleviate infectious diarrhea is impressive. So, the use of probiotics among HIV patients is a logical step and could be an adjunctive tool for physicians to halt the decline of the CD4 count.
Another important application for the use of probiotics is in the treatment of bacterial vaginosis (BV). BV is a vaginal infection, caused by a group of pathogens, which is extremely common, and estimated to occur in 50% of black African women. In the US, the prevalence is 29%, which again is extremely high. This infection makes a woman more vulnerable to contracting sexually transmitted infections, including HIV. Having BV is also a risk factor to transmit HIV to a partner or a newborn. Conventional antibiotic treatment of BV has a cure rate of 40% among black African women. A recent study shows that combining the probiotic strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 with an antibiotic has a cure rate of 88%.
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 |
|---|---|---|
| A | Experimental | Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14, Drug: MetronidazoleMetronidazole for 10 days, probiotics for 6 months |
| B | Placebo comparator | Dietary Supplement: Placebo, Drug: MetronidazoleMetronidazole for 10 days, placebo for 6 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirmed HIV infection.
- Participant does not meet the criteria for ARV therapy, CD4 count > 200, no clinical stage 3 or 4 [National guidelines, 2005].
- Having an intermediate Nugent score (4-6), or a positive Nugent score (7-10).
Key exclusion criteria (4 listed)
- Pregnancy or lactating.
- Menstruation at time of diagnosis.
- Hypersensitive to metronidazole/warfarin/lithium/disulfiram.
- Not willing to avoid alcohol use during the metronidazole treatment of 10 days.
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 |
|---|---|---|
| Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 | Dietary supplement | A |
| Placebo | Dietary supplement | B |
| Metronidazole | Drug | A, B |
Primary outcome
CD4 count
Time frame: assessed at 10 and 25 weeks
4 secondary outcomes
Bacterial vaginosis cure rate
Time frame: assesed at week 2, 5, 15, 25
Total serum IgE levels
Time frame: baseline and at 10 weeks
Serum cytokine levels
Time frame: baseline and at 10 weeks
Diarrhea incidence and length of episodes
Time frame: 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Derived from this study: PubMed 20801446Hummelen R, Changalucha J, Butamanya NL, Cook A, Habbema JD, Reid G. Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 to prevent or cure bacterial vaginosis among women with HIV. Int J Gynaecol Obstet. 2010 Dec;111(3):245-8. doi: 10.1016/j.ijgo.2010.07.008.
- a project of the University of Western Ontario to bring probiotics to the developing worldLink provided by the sponsor.
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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.
John Changalucha, MSc principal investigator
National Institute for Medical Research, Mwanza Research Centre
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 Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 and Metronidazole in people with HIV Infections and Diarrhea, run by National Institute for Medical Research, Tanzania 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 3 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: status not confirmed, as of the sponsor's last update on 30 Jan 2009. 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?
Results are not available in the source record.
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?
CD4 count (time frame: assessed at 10 and 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536848, which also lists 1 linked publication.
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 30 Jan 2009.