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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50012
Enrollment
80
Registered
2020-11-04
Start date
2021-01-09
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gut complaints

Interventions

The intervention group receives 5.5 g GOS in powder form. The control group receives the same amount of maltodextrin powder. Both groups need to use these powder supplements, portion packed in sache

Sponsors

Campina
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
The secondary objectives are to assess the effects of GOS on the component score of gut comfort at days 4 and 14 and the shifts in microbial composition after 21 days.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)