Diarrhea Clinical Trial
— PRETECOfficial title:
The Effect of Probiotics on E. Coli Gastroenteritis
Verified date | August 2015 |
Source | NIZO Food Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | NIZO food research | Ede |
Lead Sponsor | Collaborator |
---|---|
NIZO Food Research | Danisco |
Netherlands,
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- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total daily faecal ETEC excretion with time | 1-2 days before ETEC infection and on days 1, 2, 3, 5 and 15 after ETEC infection | No | |
Primary | Total daily faecal output with time | 1-2 days before ETEC infection and on days 1, 2, 3, 5, 15 after ETEC infection | No | |
Secondary | Bowel habits | Scored daily in a diary | No | |
Secondary | Frequency and severity of gastrointestinal symptoms | Scored daily by VAS scales in a diary | No | |
Secondary | Diarrhea severity | Determined as % faecal wet weight | 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection | No |
Secondary | Opportunistic pathogens in faeces | At a single day just before ETEC infection and at a single time point in the first week after ETEC infection | No | |
Secondary | Faecal calprotectin | 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection | No | |
Secondary | Serum antibody response to CFA II | At screening (baseline) and at days 9 and 15 after ETEC infection | No | |
Secondary | Total faecal sIgA | 1-2 days before ETEC infection and on days 1, 2, 3, 5, and 15 after ETEC infection | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06283784 -
Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients
|
N/A | |
Recruiting |
NCT03851835 -
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
|
Phase 3 | |
Completed |
NCT04003181 -
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
|
N/A | |
Completed |
NCT03596827 -
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
|
N/A | |
Recruiting |
NCT05372068 -
Cement flooRs AnD chiLd hEalth (CRADLE)
|
N/A | |
Completed |
NCT03972618 -
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
|
N/A | |
Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
Not yet recruiting |
NCT05052489 -
Registry and Clinical Observation of Children With Diarrhoeal Disease
|
||
Completed |
NCT02428647 -
Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation
|
N/A | |
Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT01739231 -
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
|
Phase 1/Phase 2 | |
Completed |
NCT01968408 -
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
|
Phase 3 | |
Not yet recruiting |
NCT01382199 -
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
|
Phase 3 | |
Terminated |
NCT01472211 -
Water-based Zinc Intervention Trial in Zinc Deficient Children
|
Phase 0 | |
Terminated |
NCT01048567 -
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|
Phase 2 | |
Completed |
NCT01438645 -
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
|
N/A | |
Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT00760851 -
Yogurt Study in Children 2-4 Years Old Attending Daycare
|
Phase 3 |