DiarrheaCORALNCT02541695
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
A study testing E. coli strain E1392-75-2A in people with Diarrhea and Gastroenteritis, run by NIZO Food Research at 2 sites in Netherlands.
Trial summary
Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, further characterization of the working-mechanism of the attenuated strain and further optimization of the study design will enable the investigators to better select those… 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, Gastroenteritis, Bacterial Infections
- What is being tested?
- E. coli strain E1392-75-2A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2015to Jan 2017
- 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
- Ability to follow verbal and written instructions;
- Age between 18 and 55 years;
- Availability of internet connection;
- BMI ≥20 and ≤27 kg/m2;
- Healthy as assessed by the NIZO food research medical questionnaire;
- Male subjects;
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- Signed informed consent;
- Voluntary participation;
- 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;
- Willingness to abstain from high calcium containing products.
- Willingness to abstain from medications that contain acetaminophen, aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs, (OTC) antacids and antimotility agents (eg, loperamide) on the three days before, during and 3 days after diarrhoeagenic E. coli challenge.
- Willingness to abstain from alcoholic beverages three days before, during and three days after diarrhoeagenic E. coli challenge.
- Willingness to give up blood donation starting 1 month prior to study start and during the entire study;
Who cannot join
- Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
- Diarrhoeagenic 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);
- Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
- High titer serum antibodies against CFA-II diarrhoeagenic 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.
- 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 allow to inform the general practitioner about abnormal results.
- Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
- 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 of NIZO food research, their partner and their first and second degree relatives;
- Reported average stool frequency of <1 or >3 per day;
- Symptoms consistent with Travelers' Diarrhoea 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), cholestyramine, antacids H2 receptor antagonists or proton pump inhibitors or 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;
- Vegetarians and vegans
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
NIZO food research
Ede, Gelderland, 6718ZB
Hospital Gelderse Vallei
Ede, Gelderland
About this study
Official title: Characterization Of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, further characterization of the working-mechanism of the attenuated strain and further optimization of the study design will enable the investigators to better select those ingredients that affect the key pathophysiological processes. The aim of the CORAL study is to further characterize and increase the discriminative power of the diarrhoeagenic E. coli challenge model.
Read the detailed description
Primary Objective:
In the CORAL study the investigators want to determine whether increasing the inoculation dose of diarrhoeagenic Escherichia coli (E. coli) to 5E10 Colony Forming Units (CFU) (at day 14) and addition of a second challenge 1E10 CFU (at day 35) will result in an increased effect-size and duration of measurable outcomes and in an expansion of the relevant clinical and biomarker readouts of the challenge model.
Secondary Objective:
By extensive biomarker and transcriptome analysis of blood and fecal samples, the investigators aim to explore the working mechanism of the non-toxin producing diarrhoeagenic E. coli strain and the kinetics of the host response to this infection. In addition, the investigators want to determine whether adding extended fasting and addition of a standardized evening meal, prior to the inoculation day, will result in a decreased between-subject variation.
Study design:
The CORAL study is a parallel 7-weeks intervention study. Subjects will be randomly assigned to one of two inoculation dosages of a live attenuated diarrhoeagenic E. coli (n=20 per group). 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 a standardized evening meal and an overnight fast, subjects will be orally infected with a live, but attenuated, diarrhoeagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose will be either 1E10 CFU (n=22) or 5E10 CFU (n=22) at study day 14). At study day 35, after a standardized evening meal and an overnight fast, all subjects will receive a second inoculation of 1E10 CFU of the ETEC vaccine (n=44).
At various time points before and after both diarrhoeagenic E. coli challenges an online diary will be kept to record all food and drinks consumption to assess dietary macronutrient intake. Moreover, subjects will report information on stool consistency, frequency and severity of symptoms. At various time points before and after both diarrhoeagenic E. coli challenges venous blood and (complete) stool samples will be collected. Blood and fecal samples are collected to quantify several infection- and immune system markers.
Study population:
Healthy male subjects, 18-55 years of age who fulfil all of the inclusion criteria and none of the exclusion criteria will participate in the CORAL study.
Intervention:
At study day 14 and 35, after a standardized evening meal and an overnight fast, all subjects will receive an inoculation of the diarrhoeagenic E. coli (1E10 CFU (n=22) or 5E10 CFU (n=22) at study day 14; 1E10 CFU (n=40) at study day 35) Subjects will be instructed to maintain their habitual diet, except for their dairy intake. Dairy has a high calcium content and contributes significantly to total daily calcium intake. These dietary guidelines will limit calcium intake on average to 500 mg/day. From our previous studies, we know that calcium can significantly reduce the gastro-intestinal symptoms induced by the E. coli strain.
Main study parameter:
- Percentage of faecal dry weight (% determined by freeze-drying)
Secondary study parameters:
- Total faecal wet weight (faecal weight in g/day)
- Time to first diarrhoeal stool (reported by the subjects in the online diary)
- Stool consistency (Bristol Stool Scale reported by the subjects in the online diary
- Number of stools with Bristol Stool Scale >4 (Bristol Stool Scale reported by the subjects in the online diary)
- Stool frequency (Stools per day reported by the subjects in the online diary)
- Incidence and duration of WHO-defined diarrhoea (Calculated from the Bristol Stool Scale and the Stool frequency reported by the subjects in the online diary)
- The incidence, duration and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary).
- In addition, the study contains an explorative phase consisting of biomarker and transcriptome analysis, in order to further explore and identify the mechanism and kinetics of the host response to the infection.
- Being tested
- E. coli strain E1392-75-2A
- Keywords
- Experimental challenge trial
- 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 E1392-75-2ABiological
Also called Escherichia coli, E1392-75-2A
At study day 14, after a standardized evening meal and an overnight fast, subjects will receive a single oral dose of the attenuated diarrhoeagenic E. coli strain E1392-75-2A (dose will be either 1E10 CFU (n=22) or 5E10 CFU (n=22)). Oral challenge will occur at 10.00 AM. Under supervision of the project team, subjects will get a NaHCO3 solution (100 ml 2% NaHCO3) to neutralize the gastric acid. After 5 minutes, they get a fruit juice (100 ml) containing the attenuated diarrhoeagenic E. coli strain at the above-mentioned dose. Subjects go home, but are not allowed to drink or eat for 1 hour.
At study day 35, after a standardized evening meal and an overnight fast, all subjects will receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli.
| Study group | Role | What they receive |
|---|---|---|
| 1E10 CFU Escherichia coli (E. coli) | Active comparator | 1E10 Colony Forming Units (CFU) Diarrhoeagenic E. coli (strain E1392-75-2A; collection NIZO food research). 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.
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 |
| 5E10 CFU Escherichia coli (E. coli) | Experimental | 5E10 Colony Forming Units (CFU) Diarrhoeagenic E. coli (strain E1392-75-2A; collection NIZO food research). 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 (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain.
At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 5E10 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of faecal dry weight from baseline
% of faecal dry weight determined by freeze-drying
Measured: Day 14-17 and Day 35-38
Secondary outcomes (3)
Change in total faecal wet weight from baseline
Total faecal weight in g/day
Measured: Day 14-17 and Day 35-38
Time to first diarrhoeal stool
Time to first diarrhoeal stool reported by subjects
Measured: Day 14-15 and Day 35-36
Change in Stool frequency from baseline
Stools per day reported the subjects
Measured: Day 14-17 and Day 35-38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra TenBruggencate, PhD, Principal investigator, NIZO Food ResearchEls VanHoffen, PhD, Principal investigator, NIZO Food ResearchAlwine Kardinaal, PhD, Principal investigator, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541695
- Sponsor's protocol ID
- NL54064.081.15
- Acronym
- CORAL
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2015
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 12891550Ouwehand AC, ten Bruggencate SJ, Schonewille AJ, Alhoniemi E, Forssten SD, Bovee-Oudenhoven IM. Lactobacillus acidophilus supplementation in human subjects and their resistance to enterotoxigenic Escherichia coli infection. Br J Nutr. 2014 Feb;111(3):465-73. doi: 10.1017/S0007114513002547. Epub 2013 Aug 12.
PubMed 23930950Ten 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 25369827van Hoffen E, Mercenier A, Vidal K, Benyacoub J, Schloesser J, Kardinaal A, Lucas-van de Bos E, van Alen I, Roggero I, Duintjer K, Berendts A, Albers R, Kleerebezem M, Ten Bruggencate S. Characterization of the pathophysiological determinants of diarrheagenic Escherichia coli infection using a challenge model in healthy adults. Sci Rep. 2021 Mar 15;11(1):6060. doi: 10.1038/s41598-021-85161-1.
PubMed 33723346
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization Of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
- ClinicalTrials.gov ID
- NCT02541695
- Acronym / sponsor ID
- CORAL / NL54064.081.15
- Keywords
- Experimental challenge trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Sep 2015 (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.
Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, further characterization of the working-mechanism of the attenuated strain and further optimization of the study design will enable the investigators to better select those ingredients that affect the key pathophysiological processes. The aim of the CORAL study is to further characterize and increase the discriminative power of the diarrhoeagenic E. coli challenge model.
Detailed description
Primary Objective:
In the CORAL study the investigators want to determine whether increasing the inoculation dose of diarrhoeagenic Escherichia coli (E. coli) to 5E10 Colony Forming Units (CFU) (at day 14) and addition of a second challenge 1E10 CFU (at day 35) will result in an increased effect-size and duration of measurable outcomes and in an expansion of the relevant clinical and biomarker readouts of the challenge model.
Secondary Objective:
By extensive biomarker and transcriptome analysis of blood and fecal samples, the investigators aim to explore the working mechanism of the non-toxin producing diarrhoeagenic E. coli strain and the kinetics of the host response to this infection. In addition, the investigators want to determine whether adding extended fasting and addition of a standardized evening meal, prior to the inoculation day, will result in a decreased between-subject variation.
Study design:
The CORAL study is a parallel 7-weeks intervention study. Subjects will be randomly assigned to one of two inoculation dosages of a live attenuated diarrhoeagenic E. coli (n=20 per group). 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 a standardized evening meal and an overnight fast, subjects will be orally infected with a live, but attenuated, diarrhoeagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose will be either 1E10 CFU (n=22) or 5E10 CFU (n=22) at study day 14). At study day 35, after a standardized evening meal and an overnight fast, all subjects will receive a second inoculation of 1E10 CFU of the ETEC vaccine (n=44).
At various time points before and after both diarrhoeagenic E. coli challenges an online diary will be kept to record all food and drinks consumption to assess dietary macronutrient intake. Moreover, subjects will report information on stool consistency, frequency and severity of symptoms. At various time points before and after both diarrhoeagenic E. coli challenges venous blood and (complete) stool samples will be collected. Blood and fecal samples are collected to quantify several infection- and immune system markers.
Study population:
Healthy male subjects, 18-55 years of age who fulfil all of the inclusion criteria and none of the exclusion criteria will participate in the CORAL study.
Intervention:
At study day 14 and 35, after a standardized evening meal and an overnight fast, all subjects will receive an inoculation of the diarrhoeagenic E. coli (1E10 CFU (n=22) or 5E10 CFU (n=22) at study day 14; 1E10 CFU (n=40) at study day 35) Subjects will be instructed to maintain their habitual diet, except for their dairy intake. Dairy has a high calcium content and contributes significantly to total daily calcium intake. These dietary guidelines will limit calcium intake on average to 500 mg/day. From our previous studies, we know that calcium can significantly reduce the gastro-intestinal symptoms induced by the E. coli strain.
Main study parameter:
- Percentage of faecal dry weight (% determined by freeze-drying)
Secondary study parameters:
- Total faecal wet weight (faecal weight in g/day)
- Time to first diarrhoeal stool (reported by the subjects in the online diary)
- Stool consistency (Bristol Stool Scale reported by the subjects in the online diary
- Number of stools with Bristol Stool Scale >4 (Bristol Stool Scale reported by the subjects in the online diary)
- Stool frequency (Stools per day reported by the subjects in the online diary)
- Incidence and duration of WHO-defined diarrhoea (Calculated from the Bristol Stool Scale and the Stool frequency reported by the subjects in the online diary)
- The incidence, duration and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary).
- In addition, the study contains an explorative phase consisting of biomarker and transcriptome analysis, in order to further explore and identify the mechanism and kinetics of the host response to the infection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1E10 CFU Escherichia coli (E. coli) | Active comparator | Biological: E. coli strain E1392-75-2A1E10 Colony Forming Units (CFU) Diarrhoeagenic E. coli (strain E1392-75-2A; collection NIZO food research). 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. 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. |
| 5E10 CFU Escherichia coli (E. coli) | Experimental | Biological: E. coli strain E1392-75-2A5E10 Colony Forming Units (CFU) Diarrhoeagenic E. coli (strain E1392-75-2A; collection NIZO food research). 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 (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain. At day 14, after a standardized evening meal and overnight fast, subjects receive a single oral dose of 5E10 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 (15 listed)
- Ability to follow verbal and written instructions;
- Age between 18 and 55 years;
- Availability of internet connection;
- BMI ≥20 and ≤27 kg/m2;
- Healthy as assessed by the NIZO food research medical questionnaire;
Key exclusion criteria (17 listed)
- Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
- Diarrhoeagenic 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);
- Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
- High titer serum antibodies against CFA-II diarrhoeagenic 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 E1392-75-2AAlso: Escherichia coli, E1392-75-2AAt study day 14, after a standardized evening meal and an overnight fast, subjects will receive a single oral dose of the attenuated diarrhoeagenic E. coli strain E1392-75-2A (dose will be either 1E10 CFU (n=22) or 5E10 CFU (n=22)). Oral challenge will occur at 10.00 AM. Under supervision of the project team, subjects will get a NaHCO3 solution (100 ml 2% NaHCO3) to neutralize the gastric acid. After 5 minutes, they get a fruit juice (100 ml) containing the attenuated diarrhoeagenic E. coli strain at the above-mentioned dose. Subjects go home, but are not allowed to drink or eat for 1 hour. At study day 35, after a standardized evening meal and an overnight fast, all subjects will receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli. | Biological | 1E10 CFU Escherichia coli (E. coli), 5E10 CFU Escherichia coli (E. coli) |
Primary outcome
Change in percentage of faecal dry weight from baseline
Time frame: Day 14-17 and Day 35-38
% of faecal dry weight determined by freeze-drying
3 secondary outcomes
Change in total faecal wet weight from baseline
Time frame: Day 14-17 and Day 35-38
Time to first diarrhoeal stool
Time frame: Day 14-15 and Day 35-36
Change in Stool frequency from baseline
Time frame: Day 14-17 and Day 35-38
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 13 Jan 2017.
- 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 23930950Ouwehand AC, ten Bruggencate SJ, Schonewille AJ, Alhoniemi E, Forssten SD, Bovee-Oudenhoven IM. Lactobacillus acidophilus supplementation in human subjects and their resistance to enterotoxigenic Escherichia coli infection. Br J Nutr. 2014 Feb;111(3):465-73. doi: 10.1017/S0007114513002547. Epub 2013 Aug 12.
- 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.
- Derived from this study: PubMed 33723346van Hoffen E, Mercenier A, Vidal K, Benyacoub J, Schloesser J, Kardinaal A, Lucas-van de Bos E, van Alen I, Roggero I, Duintjer K, Berendts A, Albers R, Kleerebezem M, Ten Bruggencate S. Characterization of the pathophysiological determinants of diarrheagenic Escherichia coli infection using a challenge model in healthy adults. Sci Rep. 2021 Mar 15;11(1):6060. doi: 10.1038/s41598-021-85161-1.
- Study locationLink provided by the sponsor.
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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.
Sandra TenBruggencate, PhD principal investigator
NIZO Food Research
Els VanHoffen, PhD principal investigator
NIZO Food Research
Alwine Kardinaal, PhD principal investigator
NIZO Food Research
2 sites 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 in people with Diarrhea and Gastroenteritis, run by NIZO Food Research at 2 sites 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 17 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 percentage of faecal dry weight from baseline (time frame: Day 14-17 and Day 35-38). 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 NCT02541695, which also lists 4 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 13 Jan 2017.