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OpenTrials
Completed

NCT Number: NCT02461485

Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms

First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.

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Key information

Conditions

Healthy Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

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

Main eligibility criteria (non-exhaustive list) are defined as:

  • Healthy Caucasian subject of both gender, aged from 18 to 69 years
  • Subject with body mass index (BMI) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded)
  • Subjects with moderate constipation defined according to ROME III adapted criteria.
  • Subjects without ongoing or diagnosed gastrointestinal disease or complications.
  • Subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function.
  • Subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.

Treatment and study plan

Fermented milk product containing Probiotics

Other

2 pots/day during 28 days

Fermented Milk Product containing Probiotics + Fibers C

Other

2 pots/day during 28 days

Fermented Milk Product containing Probiotics + Fibers W

Other

2 pots/day during 28 days

Non fermented Milk Product

Other

2 pots/day during 28 days

Primary outcomes

  1. Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.

    Time frame: Baseline and after 4 weeks.

  2. Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.

    Time frame: Baseline and after 4 weeks.

  3. Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.

    Time frame: Baseline and during the 4th week.

  4. Change in fecal bulk (stool weight) at baseline and after 4 weeks.

    Time frame: Baseline and after 4 weeks.

  5. Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.

    Time frame: Baseline and after 2 and 4 weeks. Validated questionnaire.

  6. Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.

    Time frame: Baseline and after 2 and 4 weeks. Validated questionnaire.

  7. Study product satisfaction by questionnaire after 2 and 4 weeks.

    Time frame: after 2 and 4 weeks.

  8. Adverse events in the week before baseline, at baseline, week 3, 4 and 5.

    Time frame: Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Evaluation of Effects of Fermented Dairy Products Containing Probiotics Alone or in Association With Fibers on Bowel Functions, Constipation Symptoms and Health Related Quality of Life in Adult Subjects With Moderate Constipation: an Exploratory Randomized Double-blind, Controlled Adaptive Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2015
Registry last updated
Aug 22, 2017

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.

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