The effect of galacto-oligosaccharides on gut complaints without medical diagnosis (e.g. bloating, constipation, diarrhea) in adult wome

Completed

Conditions: gut complaints
10017943

Registration Number: NL-OMON50012

Lead Sponsor: Campina

Brief Summary: Not available

Detailed Description: Not available

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
<p>The primary parameter is a component score of gut comfort feelings based on 5<br /><br>questions regarding bloating, flatulence, stomach ache, constipation and<br /><br>diarrhea of the past 7 days (each answer ranging from 0 -3; thus component<br /><br>score can range from 0-15). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to assess the effects of GOS on the component<br /><br>score of gut comfort at days 4 and 14 and the shifts in microbial composition<br /><br>after 21 days.</p><br>