Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT04121169
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 18 to 89
* In good general health as evidenced by medical history or Diagnosed with specific condition/disease or Exhibits specific clinical signs or symptoms or physical/oral examination findings
* Participant has a diagnosis of CDI defined as (i) presence of diarrhea with 4 or more unformed stools within 24 hours and (ii) positive test for toxigenic C. difficile from stools collected within 7 days.
* Participants received \< 24 h of SOC therapy for CDI.
* Participants presented with primary CDI episode or any number of CDI relapse recurrence of CDI
* Participants comply with the eligibility criteria and willing to participate in the study including the 8 week post treatment follow up period.
* White Blood Cell absolute neutrophil count \<15 x 109/L,
* Women of reproductive potential must use highly effective contraception. For those with child bearing potential, the following methods of birth control are required from Visit 1 up to at least 30 days after study treatment discontinuation: 1). Diaphragm, female condom or cervical cap, partner's use of a condom, any of which must be used in combination with a spermicide; 2). Intra-uterine device; 3). Oral or injectable contraceptive agent, implant, or transdermal contraceptive hormone patches. If a hormonal contraceptive is used, it must have been taken for at least one month prior to enrolment/randomization; 4). Sterilization method (tubal ligation/occlusion, or partner's vasectomy); 5). True abstinence from intercourse with a male partner only when this is in line with the preferred lifestyle of the subject.
* Men of reproductive potential must use condoms-
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* known allergic reactions to chicken egg components.
* Female of child bearing potential and not receiving contraception; pregnant or lactating persons.
* severe CDI defined as \>10 unformed bowel movements (UBMs)/24 h period, fever \>38.5 o C, White Blood Cell count \> 15 x 109/L, abdominal pain and tenderness on physical examination, toxic megacolon, ileus, nausea, vomiting.
* receipt of \> 24 h of SOC treatment of CDI, or fecal microbial transplant (FMT) prior to enrollment.
* treatment with another investigational drug or other intervention within 30 days prior to enrollment including intravenous immunoglobulin (IVIG) or monoclonal intravenous (IV) antibody.
* received vaccine for C. difficile.
* concurrent use of probiotics of any type during treatment and follow up.
* unable to discontinue use of opiates for diarrhea control.
* co-infection with another gastrointestinal (GI) pathogen.
* presence of Inflammatory Bowel Disease (IBS), IBS with diarrhea (IBS-D), chronic diarrhea of unknown cause.
* any condition that hinders oral consumption. Exception: nasogastric tubes can be used to administer the product.
* death likely within study interval.
* any circumstance or medical condition under the Investigator's opinion that precludes participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT04121169
Study Brief:
Protocol Section:
NCT04121169