Completed

Serum-derived Bovine Immunoglobulin Protein Isolate Impact on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy

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Study Aim

This study aims to evaluate the impact of Serum-derived Bovine Immunoglobulin Protein Isolate on the nutritional status of HIV positive individuals with HIV-associated enteropathy, specifically focusing on the frequency of daily unformed bowel movements.

What is being tested

Placebo

+ Serum-derived bovine immunoglobulin protein isolate (SBI)

+ Serum-derived bovine immunoglobulin protein isolate (SBI)

Other
Who is being recruted

Blood-Borne Infections+15

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorEntera Health, Inc
Last updated: June 21, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.

NCT01828593
Principal SponsorEntera Health, Inc
Last updated: June 21, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

103 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDigestive System DiseasesGastrointestinal DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsIntestinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsHIV Enteropathy

Criteria

5 inclusion criteria required to participate
History of HIV-1 infection
History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration
Maintained virologic suppression for 1 year
Plasma HIV viral load <= 40 copies/mL
Show More Criteria
3 exclusion criteria prevent from participating
Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
Conditions that require chronic therapy that is known to alter gut microbiota
Positive stool test for pathogenic bacteria, C. difficile or ova and parasites

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Matching Placebo

Group II

Active Comparator
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g

Group III

Active Comparator
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

AIDS Research Alliance

Los Angeles, United StatesOpen AIDS Research Alliance in Google Maps

Univ of California Davis CARES Clinic

Sacramento, United States

Univ of California SF

San Francisco, United States

Therafirst

Fort Lauderdale, United States
Completed10 Study Centers