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OpenTrials
Completed

NCT Number: NCT04424329

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Société des produits Nestlé/Metabolic Unit

Lausanne, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed
  • Adult men and women aged 18 to 45 years
  • Healthy based on the medical screening visit and medical questionnaire
  • BMI in the range of 18.5 to 29.9 kg/m2.

Exclusion criteria

  • Known food allergy and intolerance
  • Currently participating in another clinical trial or research project
  • Fewer than 5 spontaneous bowel movements per week on average
  • Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
  • Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
  • Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
  • Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
  • Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
  • 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.
  • Artificially sweetened beverage intake higher than 1000 ml/ per day
  • Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
  • Subject having a hierarchical or family link with the research team members.

Treatment and study plan

Fibers and probiotics

Dietary Supplement

A blend of fibers and seven probiotics

Primary outcomes

  1. Minimizing microbiota composition change

    Time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)

    Shotgum metagenomics

Secondary outcomes

  1. Increased intestinal microbiota diversity

    Time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)

    Measured by the Shannon diversity index

  2. Increased microbiota gene richness

    Time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)

    Measured by gene counts from metagenome sequencing of the fecal microbiota

  3. Gut comfort

    Time frame: Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)

    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)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.