Gastrointestinal benefit of dairy ingredients to prevent symptoms of gut infection in healthy adult subjects

Recruiting

• Conditions: Enterotoxigenic E. coliGut infectionsDiarrheaDairy ingredientsEnterotoxische E. coliDarm infectiesDiarreeZuivel ingredienten

• Registration Number: NL-OMON22648
• Lead Sponsor: FrieslandCampina Nederland BV

Brief Summary

Ten Bruggencate SJ, Frederiksen PD, Pedersen SM, Floris-Vollenbroek EG, Lucas-van de Bos E, van Hoffen E, Wejse PL. Dietary Milk-Fat-Globule Membrane Affects Resistance to Diarrheagenic Escherichia coli in Healthy Adults in a Randomized, Placebo-Controlled, Double-Blind Study. J Nutr 2016;146:249-55<br><br> - Ten 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;69:385-91. <br><br> - 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;111(3):465-73. <br><br> - 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;125: 469–76.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Male

2. Age between 18 and 55 years.

Exclusion Criteria

1. Acute gastroenteritis in the 2 months prior to inclusion.

2. Any confirmed or suspected immunosuppressive or immunodeficient condition including human
immunodeficiency virus infection (HIV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main study parameters:<br /><br>-Stool frequency: number of stools per<br>day, recorded in online diary<br /><br>- Diarrhea complaints as measured by GSRS questionnaire (Gastro-intestinal Symptom Rating Scale, domain diarrhea), recorded in online diary<br>

Secondary Outcome Measures

Name	Time	Method
Secondary parameter:<br /><br>- Stool consistency as measured by Bristol Stool Score (BSS, scale 1-7, recorded in<br>online diary)