Clostridium DifficileNCT03778606
Oligosaccharide for Cdiff(+) Heme-onc Patients
A study testing Potato starch in people with Clostridium Difficile and Hematologic Diseases, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Clostridium difficile causes ~453,000 infections and ~29,300 deaths per year in the US, making it the most common hospital acquired infection in the country. C. difficile is an anaerobic bacterium that has the capacity to inhabit the colon of humans and other mammals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile, Hematologic Diseases
- What is being tested?
- Potato starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all inclusion criteria to be eligible to participate in the study.
- Patients must be at least 18 years of age at time of consent.
- Positive C. difficile surveillance test.
- Absence of diarrhea or abdominal pain within the past 48 hours.
- Patient admitted in a hematology-oncology unit which for the purposes of this study will be defined as 7-CFAC and 8-CFAC.
Who cannot join
- Patients must NOT meet any exclusion criteria to be eligible to participate in the study.
- Presence of >= grade I nausea/vomiting.
- Inability to take oral medications or food.
- Expected length of hospitalization or survival less than 5 days
- Patient is only boarding in hematology-oncology units and would have not otherwise been admitted to these units.
- Unwillingness or inability to provide written informed consent.
- Women known to be pregnant or lactating during the study.
- History of inflammatory bowel disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Oligosaccharide Supplementation Among Hematology-Oncology Clostridium Difficile Colonized Patients
Clostridium difficile causes ~453,000 infections and ~29,300 deaths per year in the US, making it the most common hospital acquired infection in the country. C. difficile is an anaerobic bacterium that has the capacity to inhabit the colon of humans and other mammals. Initially thought to be a commensal, it was later found to be associated with antibiotic induced enterocolitis. Since then, it has gradually become one of the most important healthcare associated pathogens. C. difficile infection (CDI) causes colitis, which is inflammation of the colonic mucosa with a spectrum of severity from mild to more protracted diarrhea, abdominal pain, fever, toxic megacolon, sepsis, and in some instances death. Mortality occurs despite the existence of three antibiotic options. CDI is also associated with higher hospital readmission rates, and associated healthcare costs in the US are estimated at 4.8 billion dollars annually. Due to the significance of C. difficile in healthcare, hospital level C. difficile rates are publically reported and closely scrutinized by the Centers for Medicare and Medicaid. Standard infection control bundles are proving to be insufficient for controlling the national C. difficile problem. Better understanding of the biological steps preceding clinical infection and reversal of the underlying gut dysbiosis will allow us to curtail our C. difficile epidemic. The present study aims to manipulate the gut microbiota to halt the biological progression of C. difficile.
CDI is a serious problem in hematology-oncology patients. The incidence of CDI in the hematology-oncology population is much higher than in other populations and hematology-oncology inpatient units frequently have the highest incidence of CDI cases within an institution. Additionally, hematology-oncology patients have high rates of C. difficile colonization upon hospitalization and more than 50% of patients detected with C. difficile colonization before bone marrow transplantation end up diagnosed with hospital associated CDI. This finding is not trivial as CDI treatment with oral vancomycin causes major and prolonged perturbations of their intestinal microbiota, which has been associated with higher mortality. In addition to the usual complications of CDI, a higher incidence of graft-versus-host-disease has been described in patients with CDI.
Read the detailed description
Aim 1/Objective 1. Establish the feasibility of oligosaccharide supplementation and twice a week stool collections among 12 C. difficile colonized hematology-oncology inpatients. It will be determined if at least 70% of the oligosaccharide dosages are taken by at least 8 (>=66%) of the 12 enrolled patients. Additionally, the ability to collect at least 50% of the scheduled stool samples will be evaluated.
Aim 1 will provide important information about the ideal food/drink to mix the potato starch supplemented in this study. The knowledge gained in this pilot will be used to design a future phase II or III clinical trial.
Aim 2. Explore the impact of oligosaccharide supplementation on C. difficile loads and relative abundance of Firmicutes. All stool samples will undergo 16S ribosomal ribonucleic acid (rRNA) and bioinformatics at the MCW's Genomic and Precision Medicine Center and C. difficile quantitative polymerase chain reaction (qPCR) at the PI's research laboratory. Historical controls will be obtained from a group of over 450 hematology-oncology inpatients who underwent at least one C. difficile surveillance test and whose stool samples are currently being processed for 16S rRNA by the PI's team. Controls at a 3:1 ratio with cases will be matched based on underlying disease, unit of admission, antibiotic use, baseline C. difficile fecal loads, and baseline relative abundance of Firmicutes.
Objective 2a. Evaluate the impact of oligosaccharide supplementation on the change of C. difficile fecal loads when compared to historical controls.
Objective 2b. Explore the effect of oligosaccharide supplementation on the change in relative abundance of Firmicutes when compared to historical controls.
It is expected a reduction will occur in C. difficile fecal loads during oligosaccharide supplementation when compared to matched controls. Conversely, it is expected an increase in the relative abundance of Firmicutes (or some of its operational taxonomic units; OTUs) during oligosaccharide replacement will occur when compared to matched controls. The knowledge gained with Objectives 2a and 2b will be used to determine the sample size needed to design future phase II or phase III clinical trials.
- Conditions
- Clostridium Difficile, Hematologic Diseases
- Being tested
- Potato starch
- Keywords
- Clostridium difficile, Asymptomatic carrier, Potato starch, Non digestable oligosaccharide
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato starchDietary supplement
Potato starch will be given twice a day for up to 14 days, discharge, or death, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Potato starch supplementation | Experimental | Twelve patients found to be colonized with C. difficile will undergo twice a day potato starch supplementation. Receives: Dietary Supplement: Potato starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool samples will be collected twice a week while on potato starch supplementation and 1 time at 7-days post- starch supplementation to assess any changes in the frequency of collection during the 21-day period.
Samples will be collected twice a week (4-5 times during supplementation) and one time at day 21 or discharge, whichever happens first.
Measured: Day 1- Day 21
Oligosaccharide intake assessed by a patient diary to measure supplementation feasibility
Patients will be provided with a diary in which they will document compliance with oligosaccharide intake. It is anticipated ≥70% of intended doses to be fully administered by the patient.
Measured: Day 1-Day 14
The feasibility of collecting all available stool samples stool will be assessed. A rate ≥50% of correctly collected and processed samples will be considered feasible.
It is expected ≥50% of stool samples to be correctly collected and processed.
Measured: Day 1-Day 14
Secondary outcomes (2)
Changes in C. difficile loads will be assessed using C. difficile quantitative polymerase chain reaction (qPCR).
Stool samples collected for diagnosis and any additional stool collections will be thawed in batches and one cc aliquot will be extracted refreezing the remaining sample at -80 degrees F. One cc aliquot will then be divided into 4 sub-samples of equal volume and with the same unique identifier. This identifier will be able to chronologically cluster samples by each unique patient. A sample will be used for C. difficile qPCR quantitative determination.
Measured: Day 1-Day 14
Changes in Firmicutes' relative abundance due to oligosaccharide supplementation measured by 16S rRNA gene sequencing
Sub-sample of stool from diagnosis, and additional stool collections will be used for 16S ribosomal ribonucleic acid gene sequencing to determine the microbiome community structure
Measured: Day 1-Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jun 2019
- Primary completion31 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Munoz-Price, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778606
- Sponsor's protocol ID
- PRO00033794
- Status last verified
- Oct 2021
- First submitted
- 30 Nov 2018
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oligosaccharide Supplementation Among Hematology-Oncology Clostridium Difficile Colonized Patients
- ClinicalTrials.gov ID
- NCT03778606
- Acronym / sponsor ID
- PRO00033794
- Conditions
- Clostridium Difficile, Hematologic Diseases
- Keywords
- Clostridium difficile, Asymptomatic carrier, Potato starch, Non digestable oligosaccharide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 Dec 2018 (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.
Clostridium difficile causes ~453,000 infections and ~29,300 deaths per year in the US, making it the most common hospital acquired infection in the country. C. difficile is an anaerobic bacterium that has the capacity to inhabit the colon of humans and other mammals. Initially thought to be a commensal, it was later found to be associated with antibiotic induced enterocolitis. Since then, it has gradually become one of the most important healthcare associated pathogens. C. difficile infection (CDI) causes colitis, which is inflammation of the colonic mucosa with a spectrum of severity from mild to more protracted diarrhea, abdominal pain, fever, toxic megacolon, sepsis, and in some instances death. Mortality occurs despite the existence of three antibiotic options. CDI is also associated with higher hospital readmission rates, and associated healthcare costs in the US are estimated at 4.8 billion dollars annually. Due to the significance of C. difficile in healthcare, hospital level C. difficile rates are publically reported and closely scrutinized by the Centers for Medicare and Medicaid. Standard infection control bundles are proving to be insufficient for controlling the national C. difficile problem. Better understanding of the biological steps preceding clinical infection and reversal of the underlying gut dysbiosis will allow us to curtail our C. difficile epidemic. The present study aims to manipulate the gut microbiota to halt the biological progression of C. difficile.
CDI is a serious problem in hematology-oncology patients. The incidence of CDI in the hematology-oncology population is much higher than in other populations and hematology-oncology inpatient units frequently have the highest incidence of CDI cases within an institution. Additionally, hematology-oncology patients have high rates of C. difficile colonization upon hospitalization and more than 50% of patients detected with C. difficile colonization before bone marrow transplantation end up diagnosed with hospital associated CDI. This finding is not trivial as CDI treatment with oral vancomycin causes major and prolonged perturbations of their intestinal microbiota, which has been associated with higher mortality. In addition to the usual complications of CDI, a higher incidence of graft-versus-host-disease has been described in patients with CDI.
Detailed description
Aim 1/Objective 1. Establish the feasibility of oligosaccharide supplementation and twice a week stool collections among 12 C. difficile colonized hematology-oncology inpatients. It will be determined if at least 70% of the oligosaccharide dosages are taken by at least 8 (>=66%) of the 12 enrolled patients. Additionally, the ability to collect at least 50% of the scheduled stool samples will be evaluated.
Aim 1 will provide important information about the ideal food/drink to mix the potato starch supplemented in this study. The knowledge gained in this pilot will be used to design a future phase II or III clinical trial.
Aim 2. Explore the impact of oligosaccharide supplementation on C. difficile loads and relative abundance of Firmicutes. All stool samples will undergo 16S ribosomal ribonucleic acid (rRNA) and bioinformatics at the MCW's Genomic and Precision Medicine Center and C. difficile quantitative polymerase chain reaction (qPCR) at the PI's research laboratory. Historical controls will be obtained from a group of over 450 hematology-oncology inpatients who underwent at least one C. difficile surveillance test and whose stool samples are currently being processed for 16S rRNA by the PI's team. Controls at a 3:1 ratio with cases will be matched based on underlying disease, unit of admission, antibiotic use, baseline C. difficile fecal loads, and baseline relative abundance of Firmicutes.
Objective 2a. Evaluate the impact of oligosaccharide supplementation on the change of C. difficile fecal loads when compared to historical controls.
Objective 2b. Explore the effect of oligosaccharide supplementation on the change in relative abundance of Firmicutes when compared to historical controls.
It is expected a reduction will occur in C. difficile fecal loads during oligosaccharide supplementation when compared to matched controls. Conversely, it is expected an increase in the relative abundance of Firmicutes (or some of its operational taxonomic units; OTUs) during oligosaccharide replacement will occur when compared to matched controls. The knowledge gained with Objectives 2a and 2b will be used to determine the sample size needed to design future phase II or phase III clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potato starch supplementation | Experimental | Dietary Supplement: Potato starchTwelve patients found to be colonized with C. difficile will undergo twice a day potato starch supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must meet all inclusion criteria to be eligible to participate in the study.
- Patients must be at least 18 years of age at time of consent.
- Positive C. difficile surveillance test.
- Absence of diarrhea or abdominal pain within the past 48 hours.
- Patient admitted in a hematology-oncology unit which for the purposes of this study will be defined as 7-CFAC and 8-CFAC.
Key exclusion criteria (8 listed)
- Patients must NOT meet any exclusion criteria to be eligible to participate in the study.
- Presence of >= grade I nausea/vomiting.
- Inability to take oral medications or food.
- Expected length of hospitalization or survival less than 5 days
- Patient is only boarding in hematology-oncology units and would have not otherwise been admitted to these units.
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 |
|---|---|---|
| Potato starchPotato starch will be given twice a day for up to 14 days, discharge, or death, whichever occurs first. | Dietary supplement | Potato starch supplementation |
Primary outcome
Stool samples will be collected twice a week while on potato starch supplementation and 1 time at 7-days post- starch supplementation to assess any changes in the frequency of collection during the 21-day period.
Time frame: Day 1- Day 21
Samples will be collected twice a week (4-5 times during supplementation) and one time at day 21 or discharge, whichever happens first.
Oligosaccharide intake assessed by a patient diary to measure supplementation feasibility
Time frame: Day 1-Day 14
Patients will be provided with a diary in which they will document compliance with oligosaccharide intake. It is anticipated ≥70% of intended doses to be fully administered by the patient.
The feasibility of collecting all available stool samples stool will be assessed. A rate ≥50% of correctly collected and processed samples will be considered feasible.
Time frame: Day 1-Day 14
It is expected ≥50% of stool samples to be correctly collected and processed.
2 secondary outcomes
Changes in C. difficile loads will be assessed using C. difficile quantitative polymerase chain reaction (qPCR).
Time frame: Day 1-Day 14
Changes in Firmicutes' relative abundance due to oligosaccharide supplementation measured by 16S rRNA gene sequencing
Time frame: Day 1-Day 14
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 13 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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 Potato starch in people with Clostridium Difficile and Hematologic Diseases, run by Medical College of Wisconsin 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 8 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 13 Oct 2021. 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. 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?
Stool samples will be collected twice a week while on potato starch supplementation and 1 time at 7-days post- starch supplementation to assess any changes in the frequency of collection during the 21-day period. (time frame: Day 1- Day 21). 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?
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 Oct 2021.