Clostridium Difficile-Associated DiarrheaPhase 2/3NCT00747071
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
A Phase 2/3 study testing Colostrum in people with Clostridium Difficile-Associated Diarrhea, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile-Associated Diarrhea
- What is being tested?
- Colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Nov 2013
- Phase
- Phase 2/3
- 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
- Age 18 or older
- Written informed consent
- At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
- Confirmed diagnosis of C. difficile associated diarrhea
Who cannot join
- Pregnant or breast feeding women
- Known allergy to milk or milk products
- Other etiology of diarrhea
- Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
- Pseudomembranous colitis
- White blood count > 50,000
Show all 14Show fewer
- Blood in stools
- Laxatives or motility drugs within 12 hours
- Inability to participate in adequate follow up
- Clinically unstable
- Investigator deems unsuitable
- Immune suppression (disease or treatment)
- GI surgery
- Past intestinal parasites
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).
- Being tested
- Colostrum
- Keywords
- Clostridium difficile, diarrhea, colostrum
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColostrumDrug
Daily administration of Colostrum derived antibodies against C. difficile.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hospitalized patients with Clostridium difficile associated diarrhea. Receives: Drug: Colostrum |
| 2 | Experimental | Close hospital contacts of each index case Receives: Drug: Colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of active Clostridium difficile associated diarrhea in index cases
Measured: 60 days
New cases of Clostridium difficile associated diarrhea in close hospital contacts.
Measured: 60 days
Secondary outcomes (2)
Disease severity - duration, maximal intensity (number of stools) in index cases.
Measured: 60 days
Eradication of Clostridium difficile from stools
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Sponsors decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile-Associated DiarrheaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747071
- Sponsor's protocol ID
- 0180-08-HMO - CTIL
- Status last verified
- Jun 2011
- First submitted
- 3 Sep 2008
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
- ClinicalTrials.gov ID
- NCT00747071
- Acronym / sponsor ID
- 0180-08-HMO - CTIL
- Keywords
- Clostridium difficile, diarrhea, colostrum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsors decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 4 Sep 2008 (estimated)
- 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 clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ColostrumHospitalized patients with Clostridium difficile associated diarrhea. |
| 2 | Experimental | Drug: ColostrumClose hospital contacts of each index case |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Written informed consent
- At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
- Confirmed diagnosis of C. difficile associated diarrhea
Key exclusion criteria (14 listed)
- Pregnant or breast feeding women
- Known allergy to milk or milk products
- Other etiology of diarrhea
- Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
- Pseudomembranous colitis
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 |
|---|---|---|
| ColostrumDaily administration of Colostrum derived antibodies against C. difficile. | Drug | 1, 2 |
Primary outcome
Recurrence of active Clostridium difficile associated diarrhea in index cases
Time frame: 60 days
New cases of Clostridium difficile associated diarrhea in close hospital contacts.
Time frame: 60 days
2 secondary outcomes
Disease severity - duration, maximal intensity (number of stools) in index cases.
Time frame: 60 days
Eradication of Clostridium difficile from stools
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
Related trials for Clostridium Difficile-Associated Diarrhea
RecruitingObservational study
Natural History of Clostridioides Difficile Infection
Clostridium Difficile Infection, Health Care Associated Infection
Recruiting
Fecal Microbiota Transplantation for C Diff Infection
Clostridium Difficile Infection
Recruiting
Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
Clostridium; Difficile, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
RecruitingObservational study
Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Intestinal Infection, Clostridioides Difficile Infection
RecruitingObservational study
Washed Microbiota Transplantation for Clostridioides Difficile Infection
Clostridioides Difficile Infection
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 Phase 2/3 study testing Colostrum in people with Clostridium Difficile-Associated Diarrhea, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 28 Aug 2012. 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 Israel. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Recurrence of active Clostridium difficile associated diarrhea in index cases (time frame: 60 days). The study lists 2 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 28 Aug 2012.