Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women

Microbial Colonization Clinical Trial

— Denali  

Official title:

Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762965
• Other study ID #: 6239229900
• Status: Completed
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: July 7, 2023

Study information

• Verified date: February 2024
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.

Description:

This randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Apparently healthy women

• Aged between 40 - 70 year

• Body Mass Index (BMI) between 18.5 - 30 kg/m2

Exclusion Criteria:

• Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, Ulcerative colitis, or diagnosed irritable bowel syndrome;

• Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy;

• Diagnosed with diabetes mellitus;

• Use of medication that may influence the study results, such as laxatives, lactase preparations, metformin, antibiotics, proton pomp inhibitors, antipsychotics, NSAID's (judged by our research physician);

• Self-perceived and diagnosed constipation;

• Having a food allergy to cow's milk or being lactose intolerant;

• Self-reported slimming, medically prescribed or other diets

• Reported weight loss or weight gain of >5kg in the month prior to screening

• Use of (foods with) pre-, pro-, syn- and/or postbiotics* (should be stopped at least 4 weeks before the start of the study), or other supplements that can influence the study results (to be determined by the medical investigator);

• History of side effects with the use of prebiotic supplements

• Use of antibiotic treatment less than 3 months before start of the study

• Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported);

• Not able to comply with study procedures;

• Use of drugs (should be stopped at least 4 weeks before the study);

• Alcohol intake =7 glasses of alcoholic beverages per week, on average

• Participation in another clinical trial at the same time;

• Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or employee of FrieslandCampina R&D.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• GOS 1
1 sachet each morning
• GOS 2
1 sachet each morning

Locations

Country	Name	City	State
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University and Research	FrieslandCampina

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	faecal abundance of Bifidobacterium	faecal abundance of Bifidobacterium.	At week -3 (start control)
Primary	faecal abundance of Bifidobacterium	faecal abundance of Bifidobacterium.	At week 0 (end control)
Primary	faecal abundance of Bifidobacterium	faecal abundance of Bifidobacterium.	At week 3 (end intervention)
Secondary	Faecal microbiota composition	Gene-based microbiota profiling of faecal samples	At week -3 (start control)
Secondary	Faecal microbiota composition	Gene-based microbiota profiling of faecal samples	At week 0 (end control)
Secondary	Faecal microbiota composition	Gene-based microbiota profiling of faecal samples	At week 3 (end intervention)