The Role of Probiotics in HIV Patients With Immunological Non-Responder

NCT03568812 | Completed Phase 2 Results

• 1 other identifier: 17-10-1001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will address HIV patients who are on antiretroviral treatment (ART) and experiencing immunological failure. The cause of immunological failure in HIV patients could be due to several factors such as age, gender, Cluster of Differentiation (CD4)+ count before started treatment and some inflammation in the gut. The C-C Chemokine Receptor 5 (CCR5) receptor on T lymphocyte CD4+ are abundantly found in the gut and attacked by HIV virus during acute infection causing irreversible damage. The disruption of gut integrity and chronic inflammation further causing translocation of bacteria in gut lumen to the blood. Thus resulting persistent low CD4+ or immunological failure. This evaluation plan is designed to establish the role of investigation product (probiotics) to improve gut inflammation in HIV patients.

Conditions

HIV Infections; Immunological Abnormality

Keywords

HIV; immunological non responder; gut inflammation

Outcome Measures

Primary Outcomes (1)

• CD4+ Level

  CD4 level in blood (cell/μL) indicate immune status of patient receiving probiotics or placebo, measure between baseline and at 12 weeks of intervention. Analysis will include CD4 T cell levels after intervention, adjusted with duration of ARV therapy and baseline CD4 levels, as well as unadjusted.

  12 weeks

Secondary Outcomes (4)

• Th17 Level Change

  12 weeks

• 16S Ribosomal RNA (rRNA) Total

  12 weeks

• Fecal Calprotectin Level Change

  12 weeks

• Amount of Participants With HIV Related Symptoms

  0,4,8,12 weeks

Other Outcomes (1)

• Change in Food Frequency

  0,4, 8, 12 weeks

Study Arms (2)

Probiotics Rillus®

EXPERIMENTAL

Rillus®, Chewing tablet containing viable cell 1.0 x 10\^9 colony forming unit (Lactobacillus plantarum 8.55 mg, Streptococcus thermophilus 8.55 mg, Bifidobacterium bifidum 2.55 mg, fructooligosaccharide 480 mg), isomalt, xylitol, milk flavour, vanilla flavour Dosage: 1 chewing tablet Frequency: once daily every night Duration: 12 weeks

Drug: Rillus®

Placebo

PLACEBO COMPARATOR

Placebo: Chewing tablet with identical flavour, colour, smell, and size as investigational drug Dosage: 1 chewing tablet Frequency: once daily every night Duration: 12 weeks

Other: Placebo

Interventions

Rillus® DRUG

Eligible subjects will be divided into 2 groups randomly (Rillus® or placebo). The colour, smell, flavour, and size of the chewing tablet are the same between active and placebo drugs. Subjects will consume the tablet once daily at night for 12 weeks.

Also known as: Rillus® Treatment group

Probiotics Rillus®

Placebo OTHER

Eligible subjects will be divided into 2 groups randomly (Rillus® or placebo). The colour, smell, flavour, and size of the chewing tablet are the same between active and placebo drugs. Subjects will consume the tablet once daily at night for 12 weeks.

Also known as: Control group

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV patient with immunological non-responder status which defined as:
• first line antiretroviral therapy (ART) treated for minimal 6 months
• CD4+ level between 200-410 cell/μL
• HIV viral load \<34 copies/mL
• giving consent to participate the study

You may not qualify if:

• being pregnant
• lactating
• known Lactobacillus allergy
• BMI \<16 kg/m2
• under Tuberculosis treatment or other acute illness
• acute diarrhea
• routinely taking selenium containing vitamin in last 1 month
• routinely consuming probiotics containing product in last 1 month

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

HIV Clinic, Cipto Mangunkusumo Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

This study did not assess the viability of probiotics which were administered through the evaluation of the storage during this study.

Results Point of Contact

• Title: Dr dr. Erni Juwita Nelwan, Ph.D, Sp.PD-KPTI
• Organization: Tropical and Infectious Disease Division, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia-Cipto Mangunkusumo Hospital, Indonesia

ejnelwan@yahoo.com

+62811961229

Study Officials

• Erni J Nelwan, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double blind placebo control study

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 26, 2018
• Study Start: May 7, 2018
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-05

Locations

ID (1)