A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System

NCT01184456 | Completed Phase 2 Results DMC

• 1 other identifier: AHF-GAN01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Improvement in the rate of bacterial translocation may lead to a decrease in a chronic inflammatory response thereby decreasing CD4 destruction and HIV proliferation. By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in chronic inflammation and therefore an improvement in immune markers.

Conditions

HIV Infection; Gastrointestinal Symptoms

Keywords

AIDS; Acquired Immunodeficiency Syndrome; HIV; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues

  The primary endpoint measurement of safety is measured based on the number of adverse events reported relative to the expected number adverse events prior to the start of the study based on a risk analysis. The primary endpoint measurement of immune function is measured based on biological markers including CRP, IL-8 and TNF-alpha between the two groups. The primary endpoint measurement of gastro-intestinal issues is measured based on the number of reported symptoms relative to the expected number of gastro-intestinal issues prior to the start of the study based on a risk analysis.

  30, 60, and 90 days.

Study Arms (2)

GanedenBC30, GBI-30, PTA-6086

EXPERIMENTAL

Dietary Supplement: GanedenBC30, GBI-30, PTA-6086

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GanedenBC30, GBI-30, PTA-6086 DIETARY_SUPPLEMENT

1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.

Also known as: Bacillus coagulans, Probiotics

GanedenBC30, GBI-30, PTA-6086

Placebo DRUG

1 capsule per day for 90 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or non-pregnant, non-lactating female.
• Adults 18 years or older.
• Is able to provide written, informed consent to participate in the study.
• Serological documentation of HIV infection at any time prior to study entry and is clinically stable.
• Stable CD4 count greater than or equal to 250 cells/cubic mm for six months prior to study entry (+/- 50 cells/cubic mm).
• HIV-1 RNA ≤50 copies/mL for six months prior to study entry.
• Karnofsky performance status - 60%.
• Adequate laboratory parameters within the last 30 days:
• absolute neutrophil count \>1000 cells/cubic mm
• hemoglobin \>9.0 g/dL
• platelets \>75,000/cubic mm
• creatinine \<1.5 x upper limit of normal
• SGOT/SGPT \<3.0 x upper limit of normal
• bilirubin \<2.0 mg/dL
• Patients with documented GI symptoms to include but are not limited to: flatulence, diarrhea, bloating, gastroesophageal reflux disease, nausea, and constipation.

You may not qualify if:

• Active opportunistic infection, which is progressive, or imminently disabling or life threatening, in the judgment of the Principal Investigator with exception of Kaposi Sarcoma.
• Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks (subjects who have received intralesional chemotherapy will not be excluded, however).
• Any antibiotic therapy within 30 days of enrollment
• Any probiotic formulation within 30 days of enrollment
• Any immunization within 30 days of enrollment
• Known history of allergic reactions to any of the investigational products or their ingredients.
• Chronic treatment with immunosuppressant drugs, including corticosteroids, except for the treatment of adrenal insufficiency. Topical steroids are permitted.
• History of or known current malabsorption syndrome.
• Any grade 3 or 4 lab abnormalities as defined by a standardized grading scheme based on the DAIDS table (see Appendix B) with the following exceptions:
• Pre-existing diabetes with glucose toxicity elevations ≥ grade 3
• Triglyceride or total cholesterol elevations ≥ grade 3
• Clinical or laboratory evidence of clinically significant liver impairment/ dysfunction, disease or cirrhosis.
• Life expectancy \< 6 months in the opinion of the investigator.
• Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance.
• Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.

Sponsors & Collaborators

• AIDS Healthcare Foundation: lead
• Ganeden Biotech, Inc.: collaborator

Study Sites (1)

AHF Research Center

Beverly Hills, California, 90211, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

exopolysaccharide biopolymer, Bacillus coagulans; Probiotics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; 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; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Adam Sukhija-Cohen
• Organization: AIDS Healthcare Foundation - Public Health Division

adam.cohen@aidshealth.org

(323) 436-8900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 13, 2021
• Results First Posted: September 11, 2019

Record last verified: 2021-01

Locations

US (1)