Effect of a Specific Blend of Fibers and Probiotics on the Microbiome

Microbiota Perturbation by an Environmental Challenge Clinical Trial

Official title:

Effect of a Specific Blend of Fibers and Probiotics on the Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424329
• Other study ID #: 19.17.NRC
• Status: Completed
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: November 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Informed consent signed

2. Adult men and women aged 18 to 45 years

3. Healthy based on the medical screening visit and medical questionnaire

4. BMI in the range of 18.5 to 29.9 kg/m2.

Exclusion Criteria:

1. Known food allergy and intolerance

2. Currently participating in another clinical trial or research project

3. Fewer than 5 spontaneous bowel movements per week on average

4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily

5. Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment

6. Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment

7. Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents

8. Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)

9. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.

10. Artificially sweetened beverage intake higher than 1000 ml/ per day

11. Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.

12. Subject having a hierarchical or family link with the research team members.

Related Conditions & MeSH terms

• Microbiota Perturbation by an Environmental Challenge

Intervention

Dietary Supplement:
• Fibers and probiotics
A blend of fibers and seven probiotics

Locations

Country	Name	City	State
Switzerland	Société des produits Nestlé/Metabolic Unit	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimizing microbiota composition change	Shotgum metagenomics	Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)
Secondary	Increased intestinal microbiota diversity	Measured by the Shannon diversity index	Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Secondary	Increased microbiota gene richness	Measured by gene counts from metagenome sequencing of the fecal microbiota	Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Secondary	Gut comfort	Assessed each Gastrointestinal Symptoms (VOMITING, NAUSEA, AUDIBLE BOWEL SOUNDS, FLATULENCE, ABDOMINAL CRAMPS, BLOATING ) with a scale (from 0 to 10, 10 being the worst outcome)	Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)