Renal TransplantationEarly Phase 1NCT06150287
Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
A Early Phase 1 study testing Florajen Digestion in people with Renal Transplantation, run by State University of New York - Upstate Medical University.
Trial summary
The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Florajen Digestion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received living or deceased donor kidney, subjects will be monitored peri-operatively
- Presence of mild to severe diarrhea (> 3 times loose stools/day); include type 6 and 7 in the Bristol Stool Chart.
- Has been on adjusted and/or maintenance dose of calcineurin inhibitors, antimetabolites and steroid regimen. Treatment of rejection including administration of steroids, intravenous immunoglobulin/plasmapheresis, rituximab and anti- thymocytes are also acceptable in this research.
Who cannot join
- Pregnant and lactating women
- Has been receiving probiotics treatment
- Recurrence of gastrointestinal diseases including inflammatory bowel diseases, diverticulosis, irritable bowel syndrome. Had past surgical history of gastric bypass.
- Diagnosed with cancer
- Presence of infectious diarrhea, fever and high white blood cells (WBC) count. Infectious diarrhea is defined by polymerase chain reaction (PCR) negative for community acquired diarrhea panel [positive for Sapo virus, Noro virus, Clostridium difficile (positive for toxin A and B), Yersinia enterocolitica [(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)].
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are:
- Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea?
- Does probiotics effective in reducing inflammation?
- Is there any connection between fecal microbiome and immunological markers?
Participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.
- Conditions
- Renal Transplantation
- Being tested
- Florajen Digestion
- Keywords
- Probiotics, Immunosuppressive Drugs, Renal Transplantation, Diarrhea, Living Donor, Deceased Donor
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florajen DigestionOther
Also called Placebo
Florajen Digestion is a probiotics. One probiotics capsule contains 15 billion Colony Forming Unit (CFU) of live microorganisms. No live microorganisms are present in the placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Group | Active comparator | Participants will receive one probiotics capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea. Receives: Other: Florajen Digestion |
| Placebo Group | Placebo comparator | Participants will receive one placebo capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea. Receives: Other: Florajen Digestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in immunosuppressive drugs-associated diarrhea
Gastrointestinal (GI) questionnaire and Bristol Stool Chart will be used to measure this outcome through Chi-Square test.
Measured: GI questionnaire and Bristol Stool Chart will be collected daily for six months from the onset of post-surgical, non-infectious diarrhea.
Analysis of inflammatory biomarkers
Inflammatory biomarkers including TNF (tumor necrosis factor) superfamily proteins, IFN (interferon) family proteins, Treg cytokines and matrix metalloproteinases (MMP) [processed through Bio-Rad's Multiplex System) will be analyzed through general linear model analysis of variance (GLM ANOVA).
Measured: Whole blood will be collected three times for six months: baseline (on the day of transplant), 3 month and six month from the onset of post-surgical, non-infectious diarrhea. three and six months
Association between inflammatory markers and fecal microbiome
Fecal microbial DNA will be analyzed through 16S PCR followed by Next-Gen sequencing. Pearson correlation analysis will be performed.
Measured: Stool samples will be collected seven times for six months: baseline (on the day of transplant), then monthly once from the onset of post-surgical, non-infectious diarrhea.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study startDec 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blinded, placebo-controlled, single-center pilot/exploratory trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Saidi, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150287
- Sponsor's protocol ID
- 2044457
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy M, Podolak T, Pankewycz O and Leftavi MR. Effect of Probiotics on Immunosuppressive Drugs Associated Diarrhea in Renal Transplant Recipients: A Practice-Based Observation. Renal Journal of Nutrition. 2018; 28:141.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT06150287
- Acronym / sponsor ID
- 2044457
- Conditions
- Renal Transplantation
- Keywords
- Probiotics, Immunosuppressive Drugs, Renal Transplantation, Diarrhea, Living Donor, Deceased Donor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are:
- Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea?
- Does probiotics effective in reducing inflammation?
- Is there any connection between fecal microbiome and immunological markers?
Participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blinded, placebo-controlled, single-center pilot/exploratory trial
| Arm | Type | Receives |
|---|---|---|
| Probiotics Group | Active comparator | Other: Florajen DigestionParticipants will receive one probiotics capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea. |
| Placebo Group | Placebo comparator | Other: Florajen DigestionParticipants will receive one placebo capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received living or deceased donor kidney, subjects will be monitored peri-operatively
- Presence of mild to severe diarrhea (> 3 times loose stools/day); include type 6 and 7 in the Bristol Stool Chart.
- Has been on adjusted and/or maintenance dose of calcineurin inhibitors, antimetabolites and steroid regimen. Treatment of rejection including administration of steroids, intravenous immunoglobulin/plasmapheresis, rituximab and anti- thymocytes are also acceptable in this research.
Key exclusion criteria (5 listed)
- Pregnant and lactating women
- Has been receiving probiotics treatment
- Recurrence of gastrointestinal diseases including inflammatory bowel diseases, diverticulosis, irritable bowel syndrome. Had past surgical history of gastric bypass.
- Diagnosed with cancer
- Presence of infectious diarrhea, fever and high white blood cells (WBC) count. Infectious diarrhea is defined by polymerase chain reaction (PCR) negative for community acquired diarrhea panel [positive for Sapo virus, Noro virus, Clostridium difficile (positive for toxin A and B), Yersinia enterocolitica [(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Florajen DigestionAlso: PlaceboFlorajen Digestion is a probiotics. One probiotics capsule contains 15 billion Colony Forming Unit (CFU) of live microorganisms. No live microorganisms are present in the placebo capsules. | Other | Placebo Group, Probiotics Group |
Primary outcome
Reduction in immunosuppressive drugs-associated diarrhea
Time frame: GI questionnaire and Bristol Stool Chart will be collected daily for six months from the onset of post-surgical, non-infectious diarrhea.
Gastrointestinal (GI) questionnaire and Bristol Stool Chart will be used to measure this outcome through Chi-Square test.
Analysis of inflammatory biomarkers
Time frame: Whole blood will be collected three times for six months: baseline (on the day of transplant), 3 month and six month from the onset of post-surgical, non-infectious diarrhea. three and six months
Inflammatory biomarkers including TNF (tumor necrosis factor) superfamily proteins, IFN (interferon) family proteins, Treg cytokines and matrix metalloproteinases (MMP) [processed through Bio-Rad's Multiplex System) will be analyzed through general linear model analysis of variance (GLM ANOVA).
Association between inflammatory markers and fecal microbiome
Time frame: Stool samples will be collected seven times for six months: baseline (on the day of transplant), then monthly once from the onset of post-surgical, non-infectious diarrhea.
Fecal microbial DNA will be analyzed through 16S PCR followed by Next-Gen sequencing. Pearson correlation analysis will be performed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- BackgroundRoy M, Podolak T, Pankewycz O and Leftavi MR. Effect of Probiotics on Immunosuppressive Drugs Associated Diarrhea in Renal Transplant Recipients: A Practice-Based Observation. Renal Journal of Nutrition. 2018; 28:141.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reza Saidi principal investigator
State University of New York - Upstate Medical University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Florajen Digestion in people with Renal Transplantation, run by State University of New York - Upstate Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minakshi Roy (315-464-5413, roym@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in immunosuppressive drugs-associated diarrhea (time frame: GI questionnaire and Bristol Stool Chart will be collected daily for six months from the onset of post-surgical, non-infectious diarrhea.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06150287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.