GastroenteritisPRETECNCT01225042
The Effect of Probiotics on E. Coli Gastroenteritis
A study testing probiotics in people with Gastroenteritis and Bacterial Infection, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
Background: The incidence of gastrointestinal infections is very high. In European countries 10-25% of the population suffers from at least one foodborne infection per year. Probiotics may strengthen human resistance to gut infections as they may beneficially modulate the intestinal microbiota composition and… Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastroenteritis, Bacterial Infection, Diarrhea
- What is being tested?
- probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Apr 2011
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Male
- Age 20-55 yrs
- Willingness to replace habitual dairy product intake with the supplied low- calcium soy milk products
- Willingness to abstain from products with high amounts of prebiotic fibers and products with probiotics (except for the supplied one)
Who cannot join
- Current or previous underlying disease of the GI tract
- lactose intolerance
- Use of antibiotics, norit, laxatives, cholestyramine, acid burn inhibitors, immune suppressiva, prebiotics, probiotics
- detectable serum antibodies against ETEC
- carriage of streptomycin-resistant E. coli in faeces (only relevant when culturing technique for ETEC will be applied instead of specific RT-PCR)
- vegetarians
- heavy alcohol use
- drug use
Trial locations and contacts
1 site in 1 country.
About this study
Background:
The incidence of gastrointestinal infections is very high. In European countries 10-25% of the population suffers from at least one foodborne infection per year. Probiotics may strengthen human resistance to gut infections as they may beneficially modulate the intestinal microbiota composition and activity, and the immune function upon intestinal infection.
Read more
Aim:
To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli (ETEC).
Study design:
The PRETEC study is a parallel, double-blind, placebo-controled 4-weeks intervention with probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs placebo on several infection markers in response to an ETEC challenge is investigated. Participants will be randomly assigned to the probiotic or placebo group (n=21 per group). Subjects will be instructed to maintain their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose will be 10E10 CFU). This ETEC strain induces mild and short-lived infectious diarrhea symptoms. Before and after infection, a diary will be kept to write down all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also be used for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. Blood is sampled for immune response analyses and multiple faecal samples are collected to quantify several infection- and immune system markers, to determine probiotic excretion, and to verify dietary calcium intake.
Study population:
Healthy males of 20-55 yrs of age.
Interventions:
Probiotics (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material powder of identical appearance).
Primary outcomes:
Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per day).
Secondary outcomes:
Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic persistence and levels of opportunistic pathogens in the endogenous microbiota.
Read the detailed description
The timeframes for analysis of the primary and secondary outcomes is mentioned below in the Outcome Measures section.
- Conditions
- Gastroenteritis, Bacterial Infection, Diarrhea
- Being tested
- probiotics, placebo
- Keywords
- infectious diarrhea, probiotics, prevention, dietary intervention, E. coli infection, intestinal infection, intestinal resistance
- Medical subject headings
- Gastroenteritis, Bacterial Infections, Diarrhea, Dysentery, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
Freeze-dried powder, dose 10E9 CFU twice daily for 4 weeks
placeboDietary supplement
placebo consisting of carrier material powder of identical appearance
| Study group | Role | What they receive |
|---|---|---|
| probiotics | Experimental | Freeze-dried powder, dose 10E9 CFU twice daily for 4 weeks Receives: Dietary Supplement: probiotics |
| placebo | Placebo comparator | Carrier material powder of identical appearance Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily faecal ETEC excretion with time
Measured: 1-2 days before ETEC infection and on days 1, 2, 3, 5 and 15 after ETEC infection
Total daily faecal output with time
Measured: 1-2 days before ETEC infection and on days 1, 2, 3, 5, 15 after ETEC infection
Secondary outcomes (7)
Bowel habits
Measured: Scored daily in a diary
Frequency and severity of gastrointestinal symptoms
Measured: Scored daily by VAS scales in a diary
Diarrhea severity
Determined as % faecal wet weight
Measured: 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection
Opportunistic pathogens in faeces
Measured: At a single day just before ETEC infection and at a single time point in the first week after ETEC infection
Faecal calprotectin
Measured: 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection
Serum antibody response to CFA II
Measured: At screening (baseline) and at days 9 and 15 after ETEC infection
Total faecal sIgA
Measured: 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco
- Responsible party
- Sponsor
- Investigators
- Ingeborg Bovee-Oudenhoven, PhD, Principal investigator, NIZO Food ResearchSandra ten Bruggencate, PhD, Principal investigator, NIZO Food ResearchArthur Ouwehand, PhD, Principal investigator, Danisco Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225042
- Sponsor's protocol ID
- N132716.081.10
- Acronym
- PRETEC
- Status last verified
- Aug 2015
- First submitted
- 15 Oct 2010
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ouwehand 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 23930950
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on E. Coli Gastroenteritis
- ClinicalTrials.gov ID
- NCT01225042
- Acronym / sponsor ID
- PRETEC / N132716.081.10
- Conditions
- Gastroenteritis, Bacterial Infection, Diarrhea
- Keywords
- infectious diarrhea, probiotics, prevention, dietary intervention, E. coli infection, intestinal infection, intestinal resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- Danisco
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Oct 2010 (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.
Background:
The incidence of gastrointestinal infections is very high. In European countries 10-25% of the population suffers from at least one foodborne infection per year. Probiotics may strengthen human resistance to gut infections as they may beneficially modulate the intestinal microbiota composition and activity, and the immune function upon intestinal infection.
Aim:
To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli (ETEC).
Study design:
The PRETEC study is a parallel, double-blind, placebo-controled 4-weeks intervention with probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs placebo on several infection markers in response to an ETEC challenge is investigated. Participants will be randomly assigned to the probiotic or placebo group (n=21 per group). Subjects will be instructed to maintain their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose will be 10E10 CFU). This ETEC strain induces mild and short-lived infectious diarrhea symptoms. Before and after infection, a diary will be kept to write down all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also be used for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. Blood is sampled for immune response analyses and multiple faecal samples are collected to quantify several infection- and immune system markers, to determine probiotic excretion, and to verify dietary calcium intake.
Study population:
Healthy males of 20-55 yrs of age.
Interventions:
Probiotics (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material powder of identical appearance).
Primary outcomes:
Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per day).
Secondary outcomes:
Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic persistence and levels of opportunistic pathogens in the endogenous microbiota.
Detailed description
The timeframes for analysis of the primary and secondary outcomes is mentioned below in the Outcome Measures section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics | Experimental | Dietary Supplement: probioticsFreeze-dried powder, dose 10E9 CFU twice daily for 4 weeks |
| placebo | Placebo comparator | Dietary Supplement: placeboCarrier material powder of identical appearance |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Male
- Age 20-55 yrs
- Willingness to replace habitual dairy product intake with the supplied low- calcium soy milk products
- Willingness to abstain from products with high amounts of prebiotic fibers and products with probiotics (except for the supplied one)
Key exclusion criteria (8 listed)
- Current or previous underlying disease of the GI tract
- lactose intolerance
- Use of antibiotics, norit, laxatives, cholestyramine, acid burn inhibitors, immune suppressiva, prebiotics, probiotics
- detectable serum antibodies against ETEC
- carriage of streptomycin-resistant E. coli in faeces (only relevant when culturing technique for ETEC will be applied instead of specific RT-PCR)
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 |
|---|---|---|
| probioticsFreeze-dried powder, dose 10E9 CFU twice daily for 4 weeks | Dietary supplement | probiotics |
| placeboplacebo consisting of carrier material powder of identical appearance | Dietary supplement | placebo |
Primary outcome
Total daily faecal ETEC excretion with time
Time frame: 1-2 days before ETEC infection and on days 1, 2, 3, 5 and 15 after ETEC infection
Total daily faecal output with time
Time frame: 1-2 days before ETEC infection and on days 1, 2, 3, 5, 15 after ETEC infection
7 secondary outcomes
Bowel habits
Time frame: Scored daily in a diary
Frequency and severity of gastrointestinal symptoms
Time frame: Scored daily by VAS scales in a diary
Diarrhea severity
Time frame: 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection
Opportunistic pathogens in faeces
Time frame: At a single day just before ETEC infection and at a single time point in the first week after ETEC infection
Faecal calprotectin
Time frame: 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection
Serum antibody response to CFA II
Time frame: At screening (baseline) and at days 9 and 15 after ETEC infection
Total faecal sIgA
Time frame: 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection
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 27 Aug 2015.
- Results publication: 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.
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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.
Ingeborg Bovee-Oudenhoven, PhD principal investigator
NIZO Food Research
Sandra ten Bruggencate, PhD principal investigator
NIZO Food Research
Arthur Ouwehand, PhD principal investigator
Danisco Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Gastroenteritis and Bacterial Infection, 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 5 inclusion and 8 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 27 Aug 2015. 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?
Total daily faecal ETEC excretion with time (time frame: 1-2 days before ETEC infection and on days 1, 2, 3, 5 and 15 after ETEC infection). 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?
On the ClinicalTrials.gov record for NCT01225042, which also lists 1 linked publication.
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 27 Aug 2015.