Nyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota

NCT03851159 | Active Not Recruiting

• 1 other identifier: N14_10_136
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This will be the first study to evaluate the use of Nyaditum resae® as a potential agent for reducing antibiotic-associated gut dysbiosis in patients with drug-susceptible TB, and potentially improving clinical and microbiological markers of outcome

Conditions

Tuberculosis

Keywords

Microbiome

Outcome Measures

Primary Outcomes (1)

• Gut microbiome composition in placebo versus experimental arm

  Gut microbial composition determined by next-generation sequencing of bacterial DNA in stool

  Up to 18 months

Secondary Outcomes (2)

• Cytokine and cluster of differentiation (CD)4+ T-cell response in placebo versus experimental arm

  Up to 18 months

• Time to sputum conversion and reduction in bacillary load

  Up to 6 months

Study Arms (4)

No Intervention: HIV-negative

PLACEBO COMPARATOR

HIV-negative patients are selected to receive the placebo for the first two weeks of first-line TB treatment.

Other: Mannitol

Intervention: HIV-

EXPERIMENTAL

HIV-negative patients are selected to receive the food supplement for the first two weeks of first-line TB treatment.

Dietary Supplement: Nyaditum resae®

No Intervention: HIV+

PLACEBO COMPARATOR

HIV-positive patients are selected to receive the placebo for the first two weeks of first-line TB treatment.

Other: Mannitol

Intervention: HIV+:

EXPERIMENTAL

HIV-positive patients are selected to receive the food supplement for the first two weeks of first-line TB treatment.

Dietary Supplement: Nyaditum resae®

Interventions

Nyaditum resae® DIETARY_SUPPLEMENT

Heat-killed Mycobacterium manresensis

Intervention: HIV+:; Intervention: HIV-

Mannitol OTHER

Placebo

No Intervention: HIV+; No Intervention: HIV-negative

Eligibility Criteria

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

You may qualify if:

• years
• New cases
• Sputum Xpert Ultra (Xpert) positive for Mycobacterium tuberculosis
• Have not initiated TB treatment
• If HIV-positive, are stable on antiretroviral therapy

You may not qualify if:

• Resistance to any of the first-line drugs (Xpert rifampicin-resistant)
• Previous TB
• Diabetes mellitus
• Taking immunomodulatory drugs (e.g. cancer chemotherapy, tumour necrosis factor (TNF) inhibitors or other anti-inflammatory medication, phosphodiesterase inhibitors, corticosteroids within the past 6 months, and cholesterol-lowering drugs)
• Pregnant or lactating women
• Chronic hepatitis

Sponsors & Collaborators

• University of Stellenbosch: lead
• Fundació Institut Germans Trias i Pujol: collaborator

Study Sites (2)

Scottsdene Clinic

Cape Town, Western Cape, 7570, South Africa

Location

Wallacedene Clinic

Cape Town, Western Cape, 7570, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Grant Theron, PHD

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 22, 2019
• Study Start: May 10, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

ZA (2)