Early CirrhosisNCT03855956
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
A study testing KB174 and Maltodextrin in people with Early Cirrhosis, run by Kaleido Biosciences at 4 sites in United States.
Trial summary
This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Early Cirrhosis
- What is being tested?
- KB174 and Maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Feb 2019to 1 Oct 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able and willing to provide written informed consent
- Be male or female, 18 to 70 years of age (inclusive)
- Have a body mass index (BMI) ≥ 20.0 and < 40.0 kg/m2
- Well-compensated cirrhosis
- Negative for hepatocellular carcinoma (HCC)
- Adequate safety laboratory values at Screening.
Show all 9Show fewer
- Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine
- If of child bearing potential must follow contraceptive requirements of the protocol
- Have reliable internet access
Who cannot join
- Have evidence of decompensated liver disease.
- History or active GI disease.
- Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.
- Subject has a history of drug and/or alcohol abuse.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Centers of America
Hollywood, Florida, 33024
Advanced Pharma CR, LLC
Miami, Florida, 33147
Delta Research Partners
Monroe, Louisiana, 71201
Marquez Clinical Site Partners, LLC Florida Premier Research Institute
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis
This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.
- Conditions
- Early Cirrhosis
- Being tested
- KB174, Maltodextrin
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB174Other
KB174 is a novel mixture of oligosaccharides.
MaltodextrinOther
Maltodextrin is a commercially available easily digestible polysaccharide.
| Study group | Role | What they receive |
|---|---|---|
| KB174 Arm | Experimental | KB174 is a novel mixture of oligosaccharides. Receives: Other: KB174 |
| Maltodextrin Arm | Other | Maltodextrin is a commercially available easily digestible polysaccharide. Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.
Measured: Day -3 to Day 28.
Secondary outcomes (12)
Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N in stool in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post 28-day study compound consumption.
Measured: Day -3 to Day 29.
Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total nitrogen in blood in response to an amino acid challenge during Baseline [pre-study compound consumption] versus post 28-day study compound consumption.
Measured: Day -3 to Day 27.
Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total nitrogen in urine in response to an amino acid challenge during Baseline [pre study compound consumption] versus post 28-day study compound consumption.
Measured: Day -3 to Day 29.
. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total nitrogen in stool in response to an amino acid challenge during Baseline [pre study compound consumption] versus post 28-day study compound consumption.
Measured: Day -3 to Day 29.
Change in ammonia in blood for KB174 compared to Maltodextrin.
Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin
Measured: Day -3 to Day 43.
Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in total urea in urine in response to an amino acid challenge during baseline [pre study compound consumption] versus post 28-day compound consumption.
Measured: Day -3 to Day 29.
Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N-urea in urine in response to an amino acid challenge from baseline [pre study compound consumption ] versus post 28-day compound consumption.
Measured: Day -3 to Day 29.
Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Change in 15N-urea in stool in response to an amino acid challenge from baseline [pre study compound consumption ] versus post 28-day compound consumption.
Measured: Day -3 to Day 29.
Incidence of treatment-emergent adverse events from baseline to end of study.
Measured: Day -7 through Day 43 visit.
Incidence of serious adverse events from base baseline to end of study.
Measured: Day -7 through Day 43.
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.
Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions.
Measured: Day -7 through Day 43.
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid).
Measured: Day -7 through Day 43.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start27 Feb 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early CirrhosisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaleido Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855956
- Sponsor's protocol ID
- K022-118
- Status last verified
- May 2020
- First submitted
- 25 Feb 2019
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT03855956
- Acronym / sponsor ID
- K022-118
- Conditions
- Early Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 27 Feb 2019 (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.
This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KB174 Arm | Experimental | Other: KB174KB174 is a novel mixture of oligosaccharides. |
| Maltodextrin Arm | Other | Other: MaltodextrinMaltodextrin is a commercially available easily digestible polysaccharide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able and willing to provide written informed consent
- Be male or female, 18 to 70 years of age (inclusive)
- Have a body mass index (BMI) ≥ 20.0 and < 40.0 kg/m2
- Well-compensated cirrhosis
- Negative for hepatocellular carcinoma (HCC)
Key exclusion criteria (4 listed)
- Have evidence of decompensated liver disease.
- History or active GI disease.
- Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.
- Subject has a history of drug and/or alcohol abuse.
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 |
|---|---|---|
| KB174KB174 is a novel mixture of oligosaccharides. | Other | KB174 Arm |
| MaltodextrinMaltodextrin is a commercially available easily digestible polysaccharide. | Other | Maltodextrin Arm |
Primary outcome
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 28.
Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.
12 secondary outcomes
Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 29.
Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 27.
Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 29.
. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 29.
Change in ammonia in blood for KB174 compared to Maltodextrin.
Time frame: Day -3 to Day 43.
Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 29.
Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 29.
Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time frame: Day -3 to Day 29.
Incidence of treatment-emergent adverse events from baseline to end of study.
Time frame: Day -7 through Day 43 visit.
Incidence of serious adverse events from base baseline to end of study.
Time frame: Day -7 through Day 43.
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.
Time frame: Day -7 through Day 43.
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
Time frame: Day -7 through Day 43.
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 14 May 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB174 and Maltodextrin in people with Early Cirrhosis, run by Kaleido Biosciences at 4 sites 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 9 inclusion and 4 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. (time frame: Day -3 to Day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2020.