DiarrheaMIRRENCT03596827
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
A study testing E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU and E. coli strain E1392-75-2A dose 1E8 CFU in people with Diarrhea, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. 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
- Diarrhea
- What is being tested?
- E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU and E. coli strain E1392-75-2A dose 1E8 CFU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Sep 2018to 28 Feb 2019
- 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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Male
- Age between 18 and 55 years.
- BMI ≥18.5 and ≤30.0 kg/m2.
- Healthy as assessed by the NIZO health questionnaire.
- Ability to follow Dutch verbal and written instructions.
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- Availability of internet connection.
- 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 and blood samples.
- Willingness to abstain from high calcium containing products.
- Willingness to abstain from alcoholic beverages three days before, during and for 4 days after diarrheagenic E. coli challenge.
- Willingness to abstain from medications that contain acetaminophen, aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs, (OTC) antacids and antimotility agents (eg, loperamide) on the three days before, during and for 4 days after diarrheagenic E. coli challenge.
- Willingness to abstain from probiotics and prebiotic/fibers starting from runin and during the whole study.
- Willingness to give up blood donation starting at run-in and during the entire study.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Acute gastroenteritis in the 2 months prior to inclusion
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
- Disease of the GI tract, liver, gall bladder, kidney, thyroid gland (self-reported), except for appendicitis.
- History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion.
- 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 inclusion, OR planned travel to endemic countries during the length of the study.
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- Vaccination for, or ingestion of cholera within 3 years prior to inclusion, including studies at NIZO.
- Occupation involving handling of ETEC or Vibrio cholerae currently, or within 3 years prior to inclusion.
- Vaccination for, or ingestion of ETEC or E coli heat labile toxin, including E. coli challenge studies at NIZO.
- Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use, and not willing/able to stop this during the study.
- Known allergy to the following antibiotics: ciprofloxacin, trimethoprim, sulfamethoxazole, and penicillins.
- Reported average stool frequency of >3 per day or <1 per 2 days.
- Use of antibiotics, (during 6 months prior to inclusion), norit, laxatives, cholestyramine, antacids H2 receptor antagonists or proton pump inhibitors (during 3 months prior to inclusion).
- Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies).
- Vegans.
- Mental status that is incompatible with the proper conduct of the study.
- Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allowing to inform the general practitioner about abnormal results.
- Participation in any clinical trial including blood sampling and/or administration of substances starting 1 month prior to study start and during the entire study.
- Personnel that is part of the study team at NIZO, their partner and their first and second degree relatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection in Healthy Human Subjects: A Pilot Study
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. In order to make the model also suitable for dietary interventions that are aimed at support of the protective response against reinfection, the immune response triggered by the primary infection should be suboptimal. The MIRRE pilot study is set up to determine how much the primary inoculation dose of diarrheagenic E. coli should be lowered in order to result in a reduced protective response upon a secondary infection.
Read the detailed description
The MIRRE pilot study is a randomized, double-blind dose-response, parallel 7 weeks human infection study. Healthy male subjects, 18-55 years of age who fulfil all of the inclusion criteria and none of the exclusion criteria, will be randomly assigned to one of five inoculation dosages of a live attenuated diarrheagenic E. coli strain (n=6 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to reduce and standardize their dietary calcium intake. After a standardized evening meal and an overnight fast, subjects will be orally infected on day 14 and 35 with a live, but attenuated, diarrheagenic E. coli (strain E1392/75-2A; collection NIZO food research). Five groups of 6 subjects will be provided one of the following dosages at day 14: 1E10 CFU (standard dose); 1E9 CFU; 1E8 CFU; 1E7 CFU or 1E6 CFU of the E.coli strain. At study day 35, all subjects will receive a second inoculation of 1E10 CFU of the E.coli strain.
At various time points before and after diarrheagenic E. coli challenges an online diary will be kept to record information on stool consistency, frequency and severity of symptoms, and blood and stool samples are collected to quantify antibody levels and to quantify fecal infection parameters.
The hypothesis of this pilot study is that the E. coli infection dose at primary inoculation determines the outcomes of the protective immune response and the extent of clinical symptoms at a secondary inoculation.Therefore the CFA/II-specific IgG antibody response, in relation to clinical symptoms, is the main outcome.
- Conditions
- Diarrhea
- Being tested
- E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU, E. coli strain E1392-75-2A dose 1E8 CFU, E. coli strain E1392-75-2A dose 1E7 CFU, E. coli strain E1392-75-2A dose 1E6 CFU
- Keywords
- Diarrhea, Gastroenteritis, Bacterial Infections, Escherichia Coli Infections, E.coli
- Medical subject headings
- Diarrhea, Gastroenteritis, Bacterial Infections, 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 E1392-75-2A dose 1E10 CFUBiological
Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain
E. coli strain E1392-75-2A dose 1E9 CFUBiological
Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain
E. coli strain E1392-75-2A dose 1E8 CFUBiological
Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain
E. coli strain E1392-75-2A dose 1E7 CFUBiological
Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat
E. coli strain E1392-75-2A dose 1E6 CFUBiological
Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat
| Study group | Role | What they receive |
|---|---|---|
| 1E10 CFU Escherichia coli (E. coli) | Active comparator | At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E10 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. Receives: Biological: E. coli strain E1392-75-2A dose 1E10 CFU |
| 1E9 CFU Escherichia coli (E. coli) | Experimental | At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E9 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. Receives: Biological: E. coli strain E1392-75-2A dose 1E9 CFU |
| 1E8 CFU Escherichia coli (E. coli) | Experimental | At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E8 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. Receives: Biological: E. coli strain E1392-75-2A dose 1E8 CFU |
| 1E7 CFU Escherichia coli (E. coli) | Experimental | At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E7 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. Receives: Biological: E. coli strain E1392-75-2A dose 1E7 CFU |
| 1E6 CFU Escherichia coli (E. coli) | Experimental | At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E6 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. Receives: Biological: E. coli strain E1392-75-2A dose 1E6 CFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in specific antibody titer
Serum IgG-CFA/II antibody levels in relation to clinical symptoms at second E.coli inoculation
Measured: Day 14,21,28 and Day 35,42,49
Secondary outcomes (4)
Change in percentage of faecal wet weight from baseline
% of faecal wet weight determined by freeze-drying
Measured: Day 11,12 and Day 15-17. Day 33,34 and 36-38
Change in Stool consistency (Bristol stool scale) from baseline
Stool consistency for all stools reported by the subjects
Measured: Day 11-17 and Day 32-38
Change in Stool frequency from baseline
Stools per day reported by the subjects
Measured: Day 11-17 and Day 32-38
Change in incidence, duration and severity of Gastro-intestinal symptoms from baseline
Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary
Measured: Day 11-17 and Day 32-38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start26 Sep 2018
- Primary completion13 Nov 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The MIRRE pilot study is a randomized, double-blind dose-response, parallel human infection study in 30 healthy adults
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
- Investigators
- Melle van Schaik, Study director, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596827
- Sponsor's protocol ID
- NL66039.028.18
- Acronym
- MIRRE
- Status last verified
- Mar 2019
- First submitted
- 12 Jul 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bovee-Oudenhoven IM, Lettink-Wissink ML, Van Doesburg W, Witteman BJ, Van Der Meer R. Diarrhea caused by enterotoxigenic Escherichia coli infection of humans is inhibited by dietary calcium. Gastroenterology. 2003 Aug;125(2):469-76. doi: 10.1016/s0016-5085(03)00884-9.
PubMed 12891550Ten Bruggencate SJ, Girard SA, Floris-Vollenbroek EG, Bhardwaj R, Tompkins TA. The effect of a multi-strain probiotic on the resistance toward Escherichia coli challenge in a randomized, placebo-controlled, double-blind intervention study. Eur J Clin Nutr. 2015 Mar;69(3):385-91. doi: 10.1038/ejcn.2014.238. Epub 2014 Nov 5.
PubMed 25369827
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection in Healthy Human Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT03596827
- Acronym / sponsor ID
- MIRRE / NL66039.028.18
- Conditions
- Diarrhea
- Keywords
- Diarrhea, Gastroenteritis, Bacterial Infections, Escherichia Coli Infections, E.coli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 24 Jul 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.
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. In order to make the model also suitable for dietary interventions that are aimed at support of the protective response against reinfection, the immune response triggered by the primary infection should be suboptimal. The MIRRE pilot study is set up to determine how much the primary inoculation dose of diarrheagenic E. coli should be lowered in order to result in a reduced protective response upon a secondary infection.
Detailed description
The MIRRE pilot study is a randomized, double-blind dose-response, parallel 7 weeks human infection study. Healthy male subjects, 18-55 years of age who fulfil all of the inclusion criteria and none of the exclusion criteria, will be randomly assigned to one of five inoculation dosages of a live attenuated diarrheagenic E. coli strain (n=6 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to reduce and standardize their dietary calcium intake. After a standardized evening meal and an overnight fast, subjects will be orally infected on day 14 and 35 with a live, but attenuated, diarrheagenic E. coli (strain E1392/75-2A; collection NIZO food research). Five groups of 6 subjects will be provided one of the following dosages at day 14: 1E10 CFU (standard dose); 1E9 CFU; 1E8 CFU; 1E7 CFU or 1E6 CFU of the E.coli strain. At study day 35, all subjects will receive a second inoculation of 1E10 CFU of the E.coli strain.
At various time points before and after diarrheagenic E. coli challenges an online diary will be kept to record information on stool consistency, frequency and severity of symptoms, and blood and stool samples are collected to quantify antibody levels and to quantify fecal infection parameters.
The hypothesis of this pilot study is that the E. coli infection dose at primary inoculation determines the outcomes of the protective immune response and the extent of clinical symptoms at a secondary inoculation.Therefore the CFA/II-specific IgG antibody response, in relation to clinical symptoms, is the main outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- The MIRRE pilot study is a randomized, double-blind dose-response, parallel human infection study in 30 healthy adults
| Arm | Type | Receives |
|---|---|---|
| 1E10 CFU Escherichia coli (E. coli) | Active comparator | Biological: E. coli strain E1392-75-2A dose 1E10 CFUAt day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E10 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. |
| 1E9 CFU Escherichia coli (E. coli) | Experimental | Biological: E. coli strain E1392-75-2A dose 1E9 CFUAt day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E9 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. |
| 1E8 CFU Escherichia coli (E. coli) | Experimental | Biological: E. coli strain E1392-75-2A dose 1E8 CFUAt day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E8 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. |
| 1E7 CFU Escherichia coli (E. coli) | Experimental | Biological: E. coli strain E1392-75-2A dose 1E7 CFUAt day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E7 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. |
| 1E6 CFU Escherichia coli (E. coli) | Experimental | Biological: E. coli strain E1392-75-2A dose 1E6 CFUAt day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 1E6 CFU of the attenuated diarrhoeagenic E. coli strain E1392-75-2A. At day 35, after a standardized evening meal and overnight fast, all subjects receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Male
- Age between 18 and 55 years.
- BMI ≥18.5 and ≤30.0 kg/m2.
- Healthy as assessed by the NIZO health questionnaire.
Key exclusion criteria (19 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Acute gastroenteritis in the 2 months prior to inclusion
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
- Disease of the GI tract, liver, gall bladder, kidney, thyroid gland (self-reported), except for appendicitis.
- History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion.
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 E1392-75-2A dose 1E10 CFUDiarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain | Biological | 1E10 CFU Escherichia coli (E. coli) |
| E. coli strain E1392-75-2A dose 1E9 CFUDiarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain | Biological | 1E9 CFU Escherichia coli (E. coli) |
| E. coli strain E1392-75-2A dose 1E8 CFUDiarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain | Biological | 1E8 CFU Escherichia coli (E. coli) |
| E. coli strain E1392-75-2A dose 1E7 CFUDiarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat | Biological | 1E7 CFU Escherichia coli (E. coli) |
| E. coli strain E1392-75-2A dose 1E6 CFUDiarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat | Biological | 1E6 CFU Escherichia coli (E. coli) |
Primary outcome
Change in specific antibody titer
Time frame: Day 14,21,28 and Day 35,42,49
Serum IgG-CFA/II antibody levels in relation to clinical symptoms at second E.coli inoculation
4 secondary outcomes
Change in percentage of faecal wet weight from baseline
Time frame: Day 11,12 and Day 15-17. Day 33,34 and 36-38
Change in Stool consistency (Bristol stool scale) from baseline
Time frame: Day 11-17 and Day 32-38
Change in Stool frequency from baseline
Time frame: Day 11-17 and Day 32-38
Change in incidence, duration and severity of Gastro-intestinal symptoms from baseline
Time frame: Day 11-17 and Day 32-38
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 20 Mar 2019.
- Background: PubMed 12891550Bovee-Oudenhoven IM, Lettink-Wissink ML, Van Doesburg W, Witteman BJ, Van Der Meer R. Diarrhea caused by enterotoxigenic Escherichia coli infection of humans is inhibited by dietary calcium. Gastroenterology. 2003 Aug;125(2):469-76. doi: 10.1016/s0016-5085(03)00884-9.
- Background: PubMed 25369827Ten Bruggencate SJ, Girard SA, Floris-Vollenbroek EG, Bhardwaj R, Tompkins TA. The effect of a multi-strain probiotic on the resistance toward Escherichia coli challenge in a randomized, placebo-controlled, double-blind intervention study. Eur J Clin Nutr. 2015 Mar;69(3):385-91. doi: 10.1038/ejcn.2014.238. Epub 2014 Nov 5.
- Sponsor informationLink provided by the sponsor.
- 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.
Melle 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 dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU and E. coli strain E1392-75-2A dose 1E8 CFU in people with 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 16 inclusion and 19 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 20 Mar 2019. 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. 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?
Change in specific antibody titer (time frame: Day 14,21,28 and Day 35,42,49). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596827, which also lists 2 linked publications.
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 20 Mar 2019.