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Randomized controlled trial of a postbiotic’s ability to affect microbiome diversity and composition

Randomized controlled trial of PBP-GP-22 to affect microbiome composition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30327931
Enrollment
25
Registered
2021-09-14
Start date
2018-05-17
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut microbiome diversity loss in patients who receive antibiotics Other

Interventions

Patients are asked to take one capsule per day of PBPGP22 or a placebo alongside their prescribed antibiotic for approximately 20 days (variability arises because the intervention is given alongside a

Sponsors

Postbiotics Plus Research LLC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Otherwise healthy adults with a body mass index (BMI) (18-28 kg/m²) 2. Patients prescribed a course of antibiotics for 5 days or longer 3. Patients have not had another course of antibiotics in the past 6 months 4. Patients are willing to cease taking any other supplements or probiotics

Exclusion criteria

Exclusion criteria: 1. History of regular and severe constipation, diarrhea, inflammatory bowel disorder or Crohn’s disease 2. Usually experience severe diarrhea (e.g. for more than 3 days) following antibiotic treatment 3. Have a compromised immune system 4. Are taking any immune modulators 5. Have an autoimmune disorder 6. Are diabetic 7. Are taking blood pressure medication 8. Have allergies to the ingredients of T or C 9. Are pregnant 10. Are nursing

Design outcomes

Primary

MeasureTime frame
Bacterial alpha diversity measured by 16S rRNA gene sequencing of DNA in stool samples collected at three timepoints relative to the antibiotic treatment course and quantified by the inverse Simpson diversity index: on the final day of antibiotics, the first day after completing the antibiotics course, and the second day after completing the antibiotics course

Secondary

MeasureTime frame
1. Bacterial alpha diversity measured by 16S rRNA gene sequencing of DNA in stool samples collected at three timepoints relative to the antibiotic treatment course and quantified by the Shannon diversity index: on the final day of antibiotics, the first day after completing the antibiotics course, and the second day after completing the antibiotics course 2. Bacterial alpha diversity measured by 16S rRNA gene sequencing of DNA in stool samples collected at two timepoints relative to the antibiotic treatment course and quantified by the inverse Simpson diversity index: on the third and tenth day after completing the antibiotics course 3. Blood inflammation markers measured using C-reactive protein test at the end of antibiotic treatment course

Countries

United States of America

Contacts

Public ContactAubrey Levitt
research@postbioticsplus.com+1 (0)832 238 1781

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026