SafetyNCT07660107
Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study
A study testing Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly) in people with Safety and Tolerability, run by Kioga Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) is safe and well tolerated for healthy… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability
- What is being tested?
- Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals between the ages of 18 and 65
- Able to provide informed consent
- Willing to take a daily supplement
- Willing to complete at-home finger prick - blood spot samples on three occasions
- English speaking
Who cannot join
- Inability to adequately respond to questions regarding the informed consent procedure
- Currently involved in the criminal justice system as a prisoner or ward of the state
- Non-English speaking
- Current (past month) alcohol or substance abuse or dependence
- Lifetime history of bipolar disorder or psychosis
- Receiving intravenous, intramuscular, or oral antibiotics within the last month
Show all 22Show fewer
- Receiving medications that interfere with gut motility (opiates, loperamide, stool softeners)
- Presence of central venous catheters (CVCs)
- Gastrointestinal (GI) barriers as identified by the 2-week run-in period as determined by the study team (e.g., daily GI discomfort with frequent diarrhea prior to supplementation)
- Participation in conflicting interventional research protocol
- Vital signs outside of acceptable range (i.e., blood pressure >160/100, oral temperature >100°F, pulse >100)
- Use of any of the following drugs within the last 6 months: systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines or cytokine inhibitors; methotrexate or immunosuppressive cytotoxic agents
- Acute disease at the time of enrollment (defer sampling until the participant recovers-acute disease is defined as the presence of a moderate or severe illness with or without fever)
- Chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality
- History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
- Positive test for human immunodeficiency virus (HIV), Hepatitis B virus, or Hepatitis C virus
- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection
- Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
- Regular urinary incontinence necessitating use of incontinence protection garments
- Female who is pregnant or lactating
- Treatment for or suspicion of ever having had toxic shock syndrome
- Those receiving immunosuppressive drugs or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Boulder - WILD campus
Boulder, Colorado, 80301
About this study
Official title: Clinical Trial of Oral Supplementation With Novel Mycolicibacterium (KGA-10)
The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) is safe and well tolerated for healthy adults. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects and 2) is KGA-10 well tolerated.
Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to examine any adverse side effects and tolerability of KGA-10 relative to placebo.
Read more
Participants will take KGA-10 or a placebo everyday for 1 week and keep a daily log of their supplement intake that includes the time of day. Participants will complete the Generic Assessment of Side Effects - Probiotics (GASE-P)* survey to assess side effects experienced during the trial both related and not related to the supplement at baseline, 2 hrs following their first dose, 24 hrs following their first dose, and on day-7. Participants will complete the Treatment Satisfaction Questionnaire for Medication (TSQM) survey to assess tolerability/satisfaction of the supplement at 2 hrs following their first dose, 24 hrs following their first dose, and on day-7.
*Survey was modified by replacing the work "probiotic" with "postbiotic" for accuracy.
Read the detailed description
Enrolled participants reported to the study site to complete onboarding, which included baseline surveys, receipt of their 1-week supply of study supplement, and ingest their first dose of their supplement. The active treatment group received capsules containing 1 mg of KGA-10 and excipient (microcrystalline cellulose) while the placebo group received capsules of excipient only. Participants remained at the study site for two hours to be under the supervision of a medical professional to evaluate and respond to any anaphylactic, allergic, or adverse events (AE). Following the two-hour observation period, participants were cleared for release by the medical professional and provided with the 24 hr contact information (mobile phone number and email address) to reach the study principal investigator (PI) and medical professional. They were then released from the study site with the remaining 1-week supply of their supplement and completed the rest of the trial remotely via the data capture platform. Participants were instructed to seek immediate medical attention for any serious adverse events and to report any additional concerns to the study PI and/or medical professional. Additionally, participants had 24 hr access to an AE reporting mechanism on the data capture platform dashboard. Participants were informed that missed doses were not to be replaced with a double dose the following day.
- Conditions
- Safety, Tolerability
- Being tested
- Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly), Placebo (microcrystalline cellulose)
- Keywords
- KGA-10, Mycolicibacterium petrae, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)Dietary supplement
Also called NeuroAlly, KGA-10, Mycolicibacterium petrae, Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10
Heat-killed bacteria are considered postbiotics. At the time of registering this clinical trial, Mycolicibacterium petrae KGA-10 is being consider by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain therefore the proper nomenclature is "Candidatus Mycolicibacterium petrae" KGA-10.
Placebo (microcrystalline cellulose)Dietary supplement
Also called Microcrystalline Cellulose
Microcrystalline cellulose in size 1 capsule
| Study group | Role | What they receive |
|---|---|---|
| KGA-10 | Experimental | 1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule Receives: Dietary Supplement: Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly) |
| Placebo | Placebo comparator | Microcrystalline cellulose in size 1 capsule Receives: Dietary Supplement: Placebo (microcrystalline cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P)
A symptom endorsement on the GASE-P was evaluated as an adverse event if it was "Severe", endorsed as related to the supplement, and not present in the baseline GASE-P evaluation. A serious adverse event was defined as any unexpected event resulting in death, life threatening illness, suicide attempt, hospitalization or prolonged hospitalization, and/or persistent/significant disability resulting from participation in the study.
Measured: From the first dose to the end of treatment at day 7.
Secondary outcomes (1)
Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).
Secondary outcome was supplement satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM; score range: 0 to 100). This metric measures ease of administration of the supplement and participant satisfaction with the supplement with higher scores being attributed to higher tolerability/satisfaction.
Measured: From the first dose to end of the treatment period at day-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start7 Jul 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kioga Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660107
- Sponsor's protocol ID
- 13830-1_KGA-10- Safety
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie the results will be made available upon request after signing NDA.
Publications
Rief W, Barsky AJ, Glombiewski JA, Nestoriuc Y, Glaesmer H, Braehler E. Assessing general side effects in clinical trials: reference data from the general population. Pharmacoepidemiol Drug Saf. 2011 Apr;20(4):405-15. doi: 10.1002/pds.2067. Epub 2010 Nov 8.
PubMed 21442687Franzen PL, Buysse DJ, Rabinovitz M, Pollock BG, Lotrich FE. Poor sleep quality predicts onset of either major depression or subsyndromal depression with irritability during interferon-alpha treatment. Psychiatry Res. 2010 May 15;177(1-2):240-5. doi: 10.1016/j.psychres.2009.02.011. Epub 2010 Apr 9.
PubMed 20381876Farivar SS, Cunningham WE, Hays RD. Correlated physical and mental health summary scores for the SF-36 and SF-12 Health Survey, V.I. Health Qual Life Outcomes. 2007 Sep 7;5:54. doi: 10.1186/1477-7525-5-54.
PubMed 17825096Rook GA, Lowry CA, Raison CL. Microbial 'Old Friends', immunoregulation and stress resilience. Evol Med Public Health. 2013 Jan;2013(1):46-64. doi: 10.1093/emph/eot004. Epub 2013 Apr 9.
PubMed 24481186Allgire E, McAlees JW, Lewkowich IP, Sah R. Asthma and posttraumatic stress disorder (PTSD): Emerging links, potential models and mechanisms. Brain Behav Immun. 2021 Oct;97:275-285. doi: 10.1016/j.bbi.2021.06.001. Epub 2021 Jun 6.
PubMed 34107349Stamper CE, Hoisington AJ, Gomez OM, Halweg-Edwards AL, Smith DG, Bates KL, Kinney KA, Postolache TT, Brenner LA, Rook GA, Lowry CA. The Microbiome of the Built Environment and Human Behavior: Implications for Emotional Health and Well-Being in Postmodern Western Societies. Int Rev Neurobiol. 2016;131:289-323. doi: 10.1016/bs.irn.2016.07.006. Epub 2016 Sep 6.
PubMed 27793224von Hertzen L, Beutler B, Bienenstock J, Blaser M, Cani PD, Eriksson J, Farkkila M, Haahtela T, Hanski I, Jenmalm MC, Kere J, Knip M, Kontula K, Koskenvuo M, Ling C, Mandrup-Poulsen T, von Mutius E, Makela MJ, Paunio T, Pershagen G, Renz H, Rook G, Saarela M, Vaarala O, Veldhoen M, de Vos WM. Helsinki alert of biodiversity and health. Ann Med. 2015 May;47(3):218-25. doi: 10.3109/07853890.2015.1010226. Epub 2015 Apr 23.
PubMed 25904094Ruokolainen L, von Hertzen L, Fyhrquist N, Laatikainen T, Lehtomaki J, Auvinen P, Karvonen AM, Hyvarinen A, Tillmann V, Niemela O, Knip M, Haahtela T, Pekkanen J, Hanski I. Green areas around homes reduce atopic sensitization in children. Allergy. 2015 Feb;70(2):195-202. doi: 10.1111/all.12545.
PubMed 25388016Hanski I, von Hertzen L, Fyhrquist N, Koskinen K, Torppa K, Laatikainen T, Karisola P, Auvinen P, Paulin L, Makela MJ, Vartiainen E, Kosunen TU, Alenius H, Haahtela T. Environmental biodiversity, human microbiota, and allergy are interrelated. Proc Natl Acad Sci U S A. 2012 May 22;109(21):8334-9. doi: 10.1073/pnas.1205624109. Epub 2012 May 7.
PubMed 22566627
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Oral Supplementation With Novel Mycolicibacterium (KGA-10)
- ClinicalTrials.gov ID
- NCT07660107
- Acronym / sponsor ID
- 13830-1_KGA-10- Safety
- Conditions
- Safety, Tolerability
- Keywords
- KGA-10, Mycolicibacterium petrae, Safety, Tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kioga Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Boulder
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 22 Jun 2026 (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 clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) is safe and well tolerated for healthy adults. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects and 2) is KGA-10 well tolerated.
Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to examine any adverse side effects and tolerability of KGA-10 relative to placebo.
Participants will take KGA-10 or a placebo everyday for 1 week and keep a daily log of their supplement intake that includes the time of day. Participants will complete the Generic Assessment of Side Effects - Probiotics (GASE-P)* survey to assess side effects experienced during the trial both related and not related to the supplement at baseline, 2 hrs following their first dose, 24 hrs following their first dose, and on day-7. Participants will complete the Treatment Satisfaction Questionnaire for Medication (TSQM) survey to assess tolerability/satisfaction of the supplement at 2 hrs following their first dose, 24 hrs following their first dose, and on day-7.
*Survey was modified by replacing the work "probiotic" with "postbiotic" for accuracy.
Detailed description
Enrolled participants reported to the study site to complete onboarding, which included baseline surveys, receipt of their 1-week supply of study supplement, and ingest their first dose of their supplement. The active treatment group received capsules containing 1 mg of KGA-10 and excipient (microcrystalline cellulose) while the placebo group received capsules of excipient only. Participants remained at the study site for two hours to be under the supervision of a medical professional to evaluate and respond to any anaphylactic, allergic, or adverse events (AE). Following the two-hour observation period, participants were cleared for release by the medical professional and provided with the 24 hr contact information (mobile phone number and email address) to reach the study principal investigator (PI) and medical professional. They were then released from the study site with the remaining 1-week supply of their supplement and completed the rest of the trial remotely via the data capture platform. Participants were instructed to seek immediate medical attention for any serious adverse events and to report any additional concerns to the study PI and/or medical professional. Additionally, participants had 24 hr access to an AE reporting mechanism on the data capture platform dashboard. Participants were informed that missed doses were not to be replaced with a double dose the following day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KGA-10 | Experimental | Dietary Supplement: Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (microcrystalline cellulose)Microcrystalline cellulose in size 1 capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals between the ages of 18 and 65
- Able to provide informed consent
- Willing to take a daily supplement
- Willing to complete at-home finger prick - blood spot samples on three occasions
- English speaking
Key exclusion criteria (22 listed)
- Inability to adequately respond to questions regarding the informed consent procedure
- Currently involved in the criminal justice system as a prisoner or ward of the state
- Non-English speaking
- Current (past month) alcohol or substance abuse or dependence
- Lifetime history of bipolar disorder or psychosis
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 |
|---|---|---|
| Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)Also: NeuroAlly, KGA-10, Mycolicibacterium petrae, Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10Heat-killed bacteria are considered postbiotics. At the time of registering this clinical trial, Mycolicibacterium petrae KGA-10 is being consider by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain therefore the proper nomenclature is "Candidatus Mycolicibacterium petrae" KGA-10. | Dietary supplement | KGA-10 |
| Placebo (microcrystalline cellulose)Also: Microcrystalline CelluloseMicrocrystalline cellulose in size 1 capsule | Dietary supplement | Placebo |
Primary outcome
Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P)
Time frame: From the first dose to the end of treatment at day 7.
A symptom endorsement on the GASE-P was evaluated as an adverse event if it was "Severe", endorsed as related to the supplement, and not present in the baseline GASE-P evaluation. A serious adverse event was defined as any unexpected event resulting in death, life threatening illness, suicide attempt, hospitalization or prolonged hospitalization, and/or persistent/significant disability resulting from participation in the study.
1 secondary outcome
Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).
Time frame: From the first dose to end of the treatment period at day-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 21442687Rief W, Barsky AJ, Glombiewski JA, Nestoriuc Y, Glaesmer H, Braehler E. Assessing general side effects in clinical trials: reference data from the general population. Pharmacoepidemiol Drug Saf. 2011 Apr;20(4):405-15. doi: 10.1002/pds.2067. Epub 2010 Nov 8.
- Background: PubMed 20381876Franzen PL, Buysse DJ, Rabinovitz M, Pollock BG, Lotrich FE. Poor sleep quality predicts onset of either major depression or subsyndromal depression with irritability during interferon-alpha treatment. Psychiatry Res. 2010 May 15;177(1-2):240-5. doi: 10.1016/j.psychres.2009.02.011. Epub 2010 Apr 9.
- Background: PubMed 17825096Farivar SS, Cunningham WE, Hays RD. Correlated physical and mental health summary scores for the SF-36 and SF-12 Health Survey, V.I. Health Qual Life Outcomes. 2007 Sep 7;5:54. doi: 10.1186/1477-7525-5-54.
- Background: PubMed 24481186Rook GA, Lowry CA, Raison CL. Microbial 'Old Friends', immunoregulation and stress resilience. Evol Med Public Health. 2013 Jan;2013(1):46-64. doi: 10.1093/emph/eot004. Epub 2013 Apr 9.
- Background: PubMed 34107349Allgire E, McAlees JW, Lewkowich IP, Sah R. Asthma and posttraumatic stress disorder (PTSD): Emerging links, potential models and mechanisms. Brain Behav Immun. 2021 Oct;97:275-285. doi: 10.1016/j.bbi.2021.06.001. Epub 2021 Jun 6.
- Background: PubMed 27793224Stamper CE, Hoisington AJ, Gomez OM, Halweg-Edwards AL, Smith DG, Bates KL, Kinney KA, Postolache TT, Brenner LA, Rook GA, Lowry CA. The Microbiome of the Built Environment and Human Behavior: Implications for Emotional Health and Well-Being in Postmodern Western Societies. Int Rev Neurobiol. 2016;131:289-323. doi: 10.1016/bs.irn.2016.07.006. Epub 2016 Sep 6.
- Background: PubMed 25904094von Hertzen L, Beutler B, Bienenstock J, Blaser M, Cani PD, Eriksson J, Farkkila M, Haahtela T, Hanski I, Jenmalm MC, Kere J, Knip M, Kontula K, Koskenvuo M, Ling C, Mandrup-Poulsen T, von Mutius E, Makela MJ, Paunio T, Pershagen G, Renz H, Rook G, Saarela M, Vaarala O, Veldhoen M, de Vos WM. Helsinki alert of biodiversity and health. Ann Med. 2015 May;47(3):218-25. doi: 10.3109/07853890.2015.1010226. Epub 2015 Apr 23.
- Background: PubMed 25388016Ruokolainen L, von Hertzen L, Fyhrquist N, Laatikainen T, Lehtomaki J, Auvinen P, Karvonen AM, Hyvarinen A, Tillmann V, Niemela O, Knip M, Haahtela T, Pekkanen J, Hanski I. Green areas around homes reduce atopic sensitization in children. Allergy. 2015 Feb;70(2):195-202. doi: 10.1111/all.12545.
- Background: PubMed 22566627Hanski I, von Hertzen L, Fyhrquist N, Koskinen K, Torppa K, Laatikainen T, Karisola P, Auvinen P, Paulin L, Makela MJ, Vartiainen E, Kosunen TU, Alenius H, Haahtela T. Environmental biodiversity, human microbiota, and allergy are interrelated. Proc Natl Acad Sci U S A. 2012 May 22;109(21):8334-9. doi: 10.1073/pnas.1205624109. Epub 2012 May 7.
- Individual participant dataSharing planned: Yes. IPD that underlie the results will be made available upon request after signing NDA.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly) in people with Safety and Tolerability, run by Kioga Inc. at 1 site in United States.
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 5 inclusion and 22 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P) (time frame: From the first dose to the end of treatment at day 7.). 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 NCT07660107, which also lists 9 linked publications.
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 22 Jun 2026.