The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients

NCT00536848 | Unknown Phase 2

• 1 other identifier: MRRC HIV-Probiotics15
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Diarrhea; Bacterial Vaginosis

Keywords

Probiotics; HIV; AIDS; Diarrhea; Lactobacillus rhamnosus GR-1; Lactobacillus reuteri RC-14; Immune system; Infectious Diseases; Complementary Therapies; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• CD4 count

  assessed at 10 and 25 weeks

Secondary Outcomes (4)

• Bacterial vaginosis cure rate

  assesed at week 2, 5, 15, 25

• Total serum IgE levels

  baseline and at 10 weeks

• Serum cytokine levels

  baseline and at 10 weeks

• Diarrhea incidence and length of episodes

  25 weeks

Study Arms (2)

A

EXPERIMENTAL

Metronidazole for 10 days, probiotics for 6 months

Dietary Supplement: Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14; Drug: Metronidazole

B

PLACEBO COMPARATOR

Metronidazole for 10 days, placebo for 6 months

Dietary Supplement: Placebo; Drug: Metronidazole

Interventions

Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14 DIETARY_SUPPLEMENT

A

Placebo DIETARY_SUPPLEMENT

B

Metronidazole DRUG

A; B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute for Medical Research, Tanzania: lead
• University of Western Ontario, Canada: collaborator
• Erasmus Medical Center: collaborator
• Sekou-Toure Regional Hosipital, Mwanza, Tanzania: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• Danone Institute International: collaborator

Study Sites (1)

Sekou-Toure Regional Hospital

Mwanza, p.o. box 1663, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 20801446 DERIVED

Related Links

• a project of the University of Western Ontario to bring probiotics to the developing world

MeSH Terms

Conditions

HIV Infections; Diarrhea; Vaginosis, Bacterial; Acquired Immunodeficiency Syndrome; Communicable Diseases

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Slow Virus Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John Changalucha, MSc

  National Institute for Medical Research, Mwanza Research Centre

  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 GOV

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

TA (1)