Traveler's DiarrheaAPA12/PANTERNCT03301103
PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli
A study testing E. coli strain E1392-75-2A and PTM202 in people with Traveler's Diarrhea, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
The APA12/PANTER study is a parallel 3-weeks intervention study. Subjects will be randomly assigned to one of two treatment groups; placebo or PTM202 (n=36 per group). After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli at study day 14. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Traveler's Diarrhea
- What is being tested?
- E. coli strain E1392-75-2A and PTM202
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Dec 2017to 16 Mar 2018
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male;
- Age between 18 and 55 years;
- BMI ≥18 and ≤27 kg/m2;
- Healthy as assessed by the NIZO food research medical questionnaire.
- Ability to follow verbal and written instructions;
- Availability of internet connection;
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- Signed informed consent;
- Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned;
- Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years;
- Willing to comply with study procedures, including collection of stool samples;
- Willingness to abstain from high calcium containing products;
- Willingness to abstain from alcoholic beverages three days before, during and for four days after diarrheagenic E. coli challenge;
- Willingness to abstain from antibiotics, norit, laxatives, nonsteroidal anti-inflammatory drugs (OTC), opiates, antacids, proton pump inhibitors, and antimotility agents (e.g., loperamide) on the three days before, during and for four days after diarrheagenic E. coli challenge.
- Willingness to abstain from probiotics three days before, during and for four days after diarrheagenic E. coli challenge;
- Willingness to give up blood donation starting 1 month prior to study start and during the entire study;
Who cannot join
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV);
- Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
- Diarrheagenic E. coli strain (as used in the study) detected in fecal sample at screening;
- Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use);
- High titer serum antibodies against CFA-II diarrheagenic E. coli strain (as used in the study) at screening;
- History of microbiologically confirmed ETEC or cholera infection in last 3 years;
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- Known allergy to the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillins;
- Known allergy to soy, milk- and/or egg;
- Mental status that is incompatible with the proper conduct of the study;
- Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years;
- Reported average stool frequency of <1 or >3 per day;
- Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study;
- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholesterol lowering agents, antacids, proton pump inhibitors and immune suppressive agents (up till 3 months prior to inclusion);
- Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion;
- Vegans.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PTM202 and Modulation of Host Resistance to Diarrheagenic Escherichia Coli in a Randomized, Double-blind, Placebo Controlled Study in Healthy Human Subjects
The APA12/PANTER study is a parallel 3-weeks intervention study. Subjects will be randomly assigned to one of two treatment groups; placebo or PTM202 (n=36 per group). After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli at study day 14. At various time points before and after diarrheagenic E. coli challenge an online diary will be kept to record information on stool consistency, frequency and severity of symptoms and stool samples will be collected to determine total fecal wet weight and percentage of fecal wet weight.
Read the detailed description
The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. The study will include 2 arms; PTM202 and placebo. Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).
At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula containing dried bovine colostrum and dried whole egg.
Before and after the diarrheagenic E. coli challenge an online diary will be kept to record information on stool consistency, frequency, severity of symptoms and mediation intake. At various time points before and after diarrheagenic E. coli challenge stool samples will be collected. The main study parameters are Stool consistency (Bristol Stool Scale reported by the subjects in the online diary, and Percentage of fecal wet weight (% determined by freeze-drying).
Secondary study parameters are: Stool frequency (Stools per day reported by the subjects in the online diary), Total fecal wet weight (fecal weight in g/day), and the incidence and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary).
- Conditions
- Traveler's Diarrhea
- Being tested
- E. coli strain E1392-75-2A, PTM202
- Keywords
- Nutrition, Gastroenteritis, Traveler's diarrhea, E. coli
- Medical subject headings
- Gastroenteritis, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli strain E1392-75-2ABiological
After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).
PTM202Device
PTM202 is a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo will consist of low-lactose isonitrogenous soy product, and will be matched in appearance and flavour to PTM202.
After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). Receives: Biological: E. coli strain E1392-75-2A |
| PTM202 | Experimental | PTM202 is a dry powder for reconstitution, comprised of a proprietary mixture of dried bovine colostrum and dried whole egg.
After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). Receives: Biological: E. coli strain E1392-75-2A; Device: PTM202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Change in stool consistency score (questionnaire) before and after E. coli challenge
Measured: Before challenge (Day 11-13), After challenge (Day 14-18)
Relative fecal wet weight
Change in relative fecal wet weight (freeze-drying) before and after E. coli challenge
Measured: Before challenge (Day 11-13), After challenge (Day 14-18)
Secondary outcomes (3)
Stool frequency
Change in stool frequency (questionnaire) before and after E. coli challenge
Measured: Before challenge (Day 11-13), After challenge (Day 14-18)
Total fecal wet weight
Change in total fecal wet weight (wet weight measurement) before and after E. coli challenge
Measured: Before challenge (Day 11-13), After challenge (Day 14-18)
Gastro-intestinal symptoms
Change in gastro-intestinal symptoms (questionnaire) before and after E. coli challenge
Measured: Before challenge (Day 11-13), After challenge (Day 14-18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start7 Dec 2017
- Primary completion23 Jan 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traveler's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. Subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula containing dried bovine colostrum and dried whole egg.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- PanTheryx, Inc.
- Responsible party
- Sponsor
- Investigators
- Van Schaik, Study director, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301103
- Sponsor's protocol ID
- NL62453.028.17
- Acronym
- APA12/PANTER
- Status last verified
- Jul 2018
- First submitted
- 15 Sep 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTM202 and Modulation of Host Resistance to Diarrheagenic Escherichia Coli in a Randomized, Double-blind, Placebo Controlled Study in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT03301103
- Acronym / sponsor ID
- APA12/PANTER / NL62453.028.17
- Conditions
- Traveler's Diarrhea
- Keywords
- Nutrition, Gastroenteritis, Traveler's diarrhea, E. coli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- PanTheryx, Inc.
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 4 Oct 2017 (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.
The APA12/PANTER study is a parallel 3-weeks intervention study. Subjects will be randomly assigned to one of two treatment groups; placebo or PTM202 (n=36 per group). After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli at study day 14. At various time points before and after diarrheagenic E. coli challenge an online diary will be kept to record information on stool consistency, frequency and severity of symptoms and stool samples will be collected to determine total fecal wet weight and percentage of fecal wet weight.
Detailed description
The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. The study will include 2 arms; PTM202 and placebo. Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).
At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula containing dried bovine colostrum and dried whole egg.
Before and after the diarrheagenic E. coli challenge an online diary will be kept to record information on stool consistency, frequency, severity of symptoms and mediation intake. At various time points before and after diarrheagenic E. coli challenge stool samples will be collected. The main study parameters are Stool consistency (Bristol Stool Scale reported by the subjects in the online diary, and Percentage of fecal wet weight (% determined by freeze-drying).
Secondary study parameters are: Stool frequency (Stools per day reported by the subjects in the online diary), Total fecal wet weight (fecal weight in g/day), and the incidence and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. Subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula containing dried bovine colostrum and dried whole egg.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: E. coli strain E1392-75-2AThe placebo will consist of low-lactose isonitrogenous soy product, and will be matched in appearance and flavour to PTM202. After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). |
| PTM202 | Experimental | Biological: E. coli strain E1392-75-2A, Device: PTM202PTM202 is a dry powder for reconstitution, comprised of a proprietary mixture of dried bovine colostrum and dried whole egg. After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male;
- Age between 18 and 55 years;
- BMI ≥18 and ≤27 kg/m2;
- Healthy as assessed by the NIZO food research medical questionnaire.
- Ability to follow verbal and written instructions;
Key exclusion criteria (15 listed)
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV);
- Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
- Diarrheagenic E. coli strain (as used in the study) detected in fecal sample at screening;
- Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use);
- High titer serum antibodies against CFA-II diarrheagenic E. coli strain (as used in the study) at screening;
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 |
|---|---|---|
| E. coli strain E1392-75-2AAfter an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). | Biological | PTM202, Placebo |
| PTM202PTM202 is a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg. | Device | PTM202 |
Primary outcome
Stool consistency
Time frame: Before challenge (Day 11-13), After challenge (Day 14-18)
Change in stool consistency score (questionnaire) before and after E. coli challenge
Relative fecal wet weight
Time frame: Before challenge (Day 11-13), After challenge (Day 14-18)
Change in relative fecal wet weight (freeze-drying) before and after E. coli challenge
3 secondary outcomes
Stool frequency
Time frame: Before challenge (Day 11-13), After challenge (Day 14-18)
Total fecal wet weight
Time frame: Before challenge (Day 11-13), After challenge (Day 14-18)
Gastro-intestinal symptoms
Time frame: Before challenge (Day 11-13), After challenge (Day 14-18)
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 18 Jul 2018.
- 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.
Van Schaik study director
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E. coli strain E1392-75-2A and PTM202 in people with Traveler's Diarrhea, run by NIZO Food Research at 1 site in Netherlands.
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 15 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: finished, as of the sponsor's last update on 18 Jul 2018. 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 Netherlands. 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.
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 consistency (time frame: Before challenge (Day 11-13), After challenge (Day 14-18)). 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 18 Jul 2018.