The effect of Lactobacillus acidophilus NCFM on E. coli gastroenteritis

Completed

• Conditions: gastroenteritis; traveler's diarrhea; 10017966; 10004018

• Registration Number: NL-OMON34373
• Lead Sponsor: Danisco Finland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

- Healthy male subjects, aged 20-55 yrs, living in the Ede/Wageningen neighbourhood
- Informed Consent

Exclusion Criteria

- Measurable serum antibody titer against enterotoxigenic E. coli
- Carrier of streptomycin-resistant E. coli (in faeces)
- Presence or former gastrointestinal diseases
- Lactose intolerance
- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressors (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion)
- Vegetarians
- Heavy alcohol use
- Drug use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Faecal ETEC excretion with time as marker of the colonization resistance<br /><br>• Total daily faecal output as marker of diarrhea</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Bowel habits<br /><br>• Frequency and severity of gastrointestinal symptoms<br /><br>• Diarrhea severity (as measured by faecal dry weight excretion and % faecal<br /><br>dry weight)<br /><br>• Opportunistic pathogens in faeces<br /><br>• Calprotectin<br /><br>• Specific serum antibody response to CFA-II<br /><br>• Total faecal sIgA</p><br>