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Darmboost

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23140
Enrollment
80
Registered
2020-11-09
Start date
2020-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

gut complaints without medical diagnoses

Interventions

The intervention group receives 5.5g GOS. The control group receives the same amount of maltodextrin powder. Both groups need to use these powder supplements, portion packed in sachets, daily for 21 d

Sponsors

FrieslandCampina
Lead Sponsor

Eligibility

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 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

MeasureTime frame
- Component (summed) score of gut comfort after 4 and 14 days. - Shifts in microbial composition (through 16s sequencing) after 21 days

Contacts

Public ContactCarly Janssen

FrieslandCampina

carly.janssen@frieslandcampina.com+31 (0)6 15 658 846

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)