GIGA Study: Gastrointestinal benefit of dairy Ingredients to prevent symptoms of Gut infection in healthy Adult subjects

Completed

• Conditions: Gastroenteritis; Travelers diarrhea; 10004018

• Registration Number: NL-OMON48558
• Lead Sponsor: FrieslandCampina Nederland BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-03
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Male
2. Age between 18 and 55 years.
3. BMI *18.5 and *30.0 kg/m2.
4. Healthy as assessed by the NIZO food research medical questionnaire.

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).
3. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported), except for appendicitis.
4. History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion.
5. Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to inclusion, OR planned travel to endemic countries during the length of the study.
6. Vaccination for, or ingestion of cholera within 3 years prior to inclusion, including studies at NIZO.
7. Occupation involving handling of ETEC or Vibrio cholerae currently, or within 3 years prior to inclusion.
8. Vaccination for, or ingestion of ETEC or E coli heat labile toxin, including E. coli challenge studies at NIZO.
9. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use, and not willing/able to stop this during the study.
10. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim, sulfamethoxazole, and penicillins.
11. Reported average stool frequency of >3 per day or <1 per 2 days.
12. Use of antibiotics (up till 6 months prior to inclusion), norit, laxatives, cholestyramine, antacids H2 receptor antagonists or proton pump inhibitors (during 3 months prior to inclusion).
13. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies).
14. Vegans.
15. Mental status that is incompatible with the proper conduct of the study.
16. A self-reported milk allergy, lactose intolerance or sensitivity to dairy ingredients.;For the subgroup of participants for exhaled breath analysis, the following additional exclusion criterion applies for participation in the VOC feasibility analysis:
History of or current self-reported or doctor-diagnosed disease of the lungs, such as asthma or COPD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters:<br /><br>* Stool frequency at day 16 (2 days after infection) compared to day 15 (1 day<br /><br>after infection): number of stools per day, recorded in online diary<br /><br>* Diarrhea complaints at day 16 compared to day 15, as measured by GSRS<br /><br>questionnaire (Gastro-intestinal Symptom Rating Scale, domain diarrhea),<br /><br>recorded in online diary</p><br>