Clostridium Difficile DiarrheaPhase 1NCT03793686
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
A Phase 1 study testing PBCLN-003 in people with Clostridium Difficile Diarrhea, run by Prolacta Bioscience at 1 site in United States.
Trial summary
This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Diarrhea
- What is being tested?
- PBCLN-003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to 1 Sep 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment episode of CDAD diagnosed based on > 3 loose stools per day and detection of CD toxin by nucleic acid amplification tests (NAAT), EIA or GDH
- Mild to moderate CDAD during enrollment episode (per Society of Hospital Epidemiologists of America (SHEA)/lnfectious Disease Society of America(ISDA) criteria)
- Current therapy with standard of care antibiotics for recurrent CDAD(vancomycin, metronidazole, fidaxomicin)
- BMI > 18.5 and < 40
- Age 18 years or older
- Agreement to adhere to the study protocol
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- Informed consent is obtained
- Women who are capable of bearing children must have a negative pregnancy test at the time of screening
- Female subjects of childbearing potential must use birth control (defined as oral or injectable contraceptives, intrauterine devices, surgical sterilization or a combination of a condom and spermicide) during the study period and for up to 8 weeks after the first drug of study.
Who cannot join
- Severe CDAD during enrollment episode (per SHEA/ISDA criteria) characterized as follows:
- History of five (5) or more recurrences of CDAD within the past 12 months prior to potential study enrollment
- History of fecal microbiome transplant or other microbiome directed experimental intervention for CDAD
- History (ever) of CD complicating inflammatory bowel disease (Crohn's disease, ulcerative colitis), or history of bowel resection surgery (other than uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea of unknown etiology since the initial episode of CDAD
- Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
- Initiating a new diet or weight loss amounting to 10% within two weeks prior to date of study entry
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- Enrolled in another clinical study for the therapy of CDAD or affecting nutritional management during the study period
- Enrolled or has been enrolled in another experimental (IND) study within two weeks prior to date of study entry
- Is pregnant or lactating
- History of swallowing difficulties, including dysphagia or odynophagia for liquids or solids
- Use of any Probiotics (any formulation) within the two weeks prior to date of study entry
- New, or a change in the consumption of the following prescription medications or over-the-counter (OTC) medications within two weeks prior to date of study entry:
- Proton pump inhibitors (for example: Prilosec®, Nexium®)
- Histamine-2 receptor antagonists (for example: Zantac®, Pepcid®)
- Consumption of the following prescription medications during the current enrollment episode: • Bezlotuxamab/Zinplava®
Trial locations and contacts
1 site in 1 country.
United States1 site
Infectious Disease Specialist
Idaho Falls, Idaho, 83404
About this study
Official title: A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea
This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.
- Conditions
- Clostridium Difficile Diarrhea
- Being tested
- PBCLN-003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBCLN-003Drug
Investigational drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts Receives: Drug: PBCLN-003 |
| Placebo | Placebo comparator | Placebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Adverse Events in a dose escalation study of PBCLN-003
Comparison of adverse event reporting and grading results between groups using physical exams, safety related blood tests, and urinalysis, adverse event reports, and subject complaint logs.
Measured: Up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start6 Dec 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Unable to enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile DiarrheaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolacta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Rechtman, MD, Study director, Vice President, Medical Affairs, Prolacta Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793686
- Sponsor's protocol ID
- 18-CT-001
- Status last verified
- Oct 2020
- First submitted
- 27 Dec 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea
- ClinicalTrials.gov ID
- NCT03793686
- Acronym / sponsor ID
- 18-CT-001
- Conditions
- Clostridium Difficile Diarrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll subjects
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 4 Jan 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 Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: PBCLN-003PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Enrollment episode of CDAD diagnosed based on > 3 loose stools per day and detection of CD toxin by nucleic acid amplification tests (NAAT), EIA or GDH
- Mild to moderate CDAD during enrollment episode (per Society of Hospital Epidemiologists of America (SHEA)/lnfectious Disease Society of America(ISDA) criteria)
- Current therapy with standard of care antibiotics for recurrent CDAD(vancomycin, metronidazole, fidaxomicin)
- BMI > 18.5 and < 40
- Age 18 years or older
Key exclusion criteria (15 listed)
- Severe CDAD during enrollment episode (per SHEA/ISDA criteria) characterized as follows:
- Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
- Initiating a new diet or weight loss amounting to 10% within two weeks prior to date of study entry
- Enrolled in another clinical study for the therapy of CDAD or affecting nutritional management during the study period
- Enrolled or has been enrolled in another experimental (IND) study within two weeks prior to date of study entry
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 |
|---|---|---|
| PBCLN-003Investigational drug | Drug | Experimental |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Characterization of Adverse Events in a dose escalation study of PBCLN-003
Time frame: Up to 8 Weeks
Comparison of adverse event reporting and grading results between groups using physical exams, safety related blood tests, and urinalysis, adverse event reports, and subject complaint logs.
Results and safety
The study was stopped early (reason given: Unable to enroll subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
David J Rechtman, MD study director
Vice President, Medical Affairs, Prolacta Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBCLN-003 in people with Clostridium Difficile Diarrhea, run by Prolacta Bioscience 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 19 Oct 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to enroll subjects). Results are not available in the source record.
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?
Characterization of Adverse Events in a dose escalation study of PBCLN-003 (time frame: Up to 8 Weeks). 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 19 Oct 2020.