Darmboost

Completed

• Conditions: gut complaints without medical diagnoses

• Registration Number: NL-OMON23140
• Lead Sponsor: FrieslandCampina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Female
- 25-45 years of age
- Component (summed) score for gut complaints = 6 (based on bloating, flatulence, stomach ache, constipation, diarrhea)

Exclusion Criteria

- Any medical diagnosed disease underlying gut-related complaints, including Irritable Bowel Syndrome, celiac disease, Crohn’s disease, colitis, haemorrhoids, cancer, and/or any other disease considered relevant as determined during screening.
- Use of antibiotics, opiates, anti-inflammatory drugs (NSAIDs) and/or metformin, and/or other medication that are known to affect the composition of the gut microbiota during the 14 days before inclusion.
- Pregnant or lactating.
- Self-reported lactose intolerance
- Self-reported cow’s milk protein allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary parameter is the gut comfort component score at day 21 of the study (component score is based on 5 questions: bloating, flatulence, stomach ache, constipation and diarrhea in the past 7 days)

Secondary Outcome Measures

Name	Time	Method
- Component (summed) score of gut comfort after 4 and 14 days.<br>- Shifts in microbial composition (through 16s sequencing) after 21 days